Canada Gazette, Part I, Volume 158, Number 22: Controlled Substances Regulations

June 1, 2024

Statutory authority
Controlled Drugs and Substances Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Executive summary

Issues

The Canadian legislative and regulatory framework for controlled substances has evolved over decades to address emerging issues and meet international commitments under the United Nations international drug control conventions. This evolution has resulted in a series of regulations that, while containing broadly similar provisions, also feature gaps and inconsistencies with respect to the authorizations and requirements that apply to the four different categories of controlled substances. While these regulations have been amended from time to time, the current regulatory framework for controlled substances presents the following issues:

• Challenges have been identified in the administration of the regulations and the compliance with them. Inconsistencies in the regulations for various categories of controlled substances can cause confusion and create unnecessary burden for Health Canada and regulated parties to administer the regulations or comply with them. For example, a pharmacist conducting activities with narcotics and targeted substances must comply with similar but sometimes different requirements under the Narcotic Control Regulations and the Benzodiazepines and Other Targeted Substances Regulations, respectively. As well, Health Canada inspectors must follow different compliance guidance when conducting an inspection as requirements may vary for different categories of controlled substances under different regulations.
• In the absence of applicable authorizations in the current regulations (the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations, Parts G and J of the Food and Drug Regulations, and the New Classes of Practitioners Regulations), certain activities have been authorized through class exemptions issued pursuant to subsection 56(1) of the Controlled Drugs and Substances Act. This causes challenges for regulated parties who must be aware of the regulatory requirements as well as the various class exemptions that have been issued, resulting in further confusion regarding the manner in which to comply.
• Health Canada, through various forms of consultations, has heard that the regulatory provisions pertaining to pharmacists should be amended to allow pharmacy technicians to independently conduct activities with controlled substances in a pharmacy setting, in line with their scope of practice, and that barriers to central fill services with controlled substances should be removed.

Background

Legislative framework for controlled substances

The Controlled Drugs and Substances Act (CDSA) provides a legislative framework for the control of substances that can alter mental processes and that pose risks to public health and public safety when used inappropriately or diverted to the illegal market. Defined as controlled substances, these substances are listed in Schedules I, II, III, IV and V to the CDSA. Some controlled substances have legitimate uses, for example, as marketed drugs that have been authorized pursuant to the Food and Drugs Act and its regulations for the treatment of various medical conditions further to a scientific review of their safety, efficacy and quality. Among other things, the CDSA enables the Governor in Council to make regulations with respect to authorizing legitimate activities with controlled substances for medical, scientific or industrial purposes and to minimize the risk of them being diverted to the illegal market or activities.

The CDSA is one of the means by which Canada, as a signatory, fulfills its obligations under the United Nations Single Convention on Narcotic Drugs, 1961 (1961 Convention), the Convention on Psychotropic Substances, 1971 (1971 Convention) and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (1988 Convention). These conventions form the basis for the current international drug control system and require the signatories to, among other things, place national controls on legitimate activities conducted by authorized persons or businesses with substances listed in the schedules to the conventions.

In general, and depending on which schedule a substance is listed, the CDSA prohibits any person from conducting activities such as production, sale/provision, importation and exportation of controlled substances unless authorized by regulation or an exemption. The CDSA also specifies the range of offences and penalties associated with conducting unauthorized activities with specific controlled substances.

The CDSA was enacted in 1996 by consolidating the Narcotic Control Act and Parts III and IV of the Food and Drugs Act, along with regulations made under them at the time. Since then, additional regulations have been made under the CDSA. Following the coming into force of the CDSA and its regulations, changes have been made to various provisions to address emerging issues and allow Canada to meet its international obligations under the above-mentioned United Nations conventions.

There are currently nine sets of regulations made or deemed to have been made under the legislative authority of the CDSA. Among them, the following regulations provide a regulatory framework governing legitimate activities with four categories of controlled substances (i.e. narcotics, controlled drugs, targeted substances, and restricted drugs) conducted by regulated parties such as licensed dealers, pharmacists, practitioners and hospitals:

• Narcotic Control Regulations (NCR): Originally made pursuant to the Narcotic Control Act, the NCR set out the circumstances and requirements under which producers, distributors, importers, exporters, pharmacists, practitioners and hospitals may conduct regulated activities with narcotics (mainly opioids such as morphine, codeine and fentanyl, and other substances such as cocaine).
• Food and Drug Regulations — Part G (FDR-G): Originally made under the Food and Drugs Act but deemed to be made under the CDSA, the FDR-G sets out circumstances and requirements under which producers, distributors, importers, exporters, pharmacists, practitioners and hospitals may conduct activities with controlled drugs (mainly stimulants such as certain amphetamines with approved medical use, sedatives such as phenobarbital and anabolic steroids such as testosterone).
• Benzodiazepines and Other Targeted Substances Regulations (BOTSR): Made under the CDSA, the BOTSR, similar to the NCR, set out the circumstances and requirements under which producers, distributors, importers, exporters, pharmacists, practitioners and hospitals may conduct regulated activities with targeted substances (mainly central nervous system depressants such as benzodiazepines).
• Food and Drug Regulations — Part J (FDR-J): Originally made under the Food and Drugs Act, but deemed to be made under the CDSA, the FDR-J sets out circumstances and requirements for producers, distributors, importers, exporters and researchers to conduct regulated activities with restricted drugs (stimulants such as certain amphetamines with no approved medical use and psychedelics such as psilocybin and LSD) for scientific research purposes. As restricted drugs have no approved therapeutic uses, the FDR-J contains no provisions in relation to pharmacists, practitioners and hospitals. Rather, these regulations set out a unique mechanism whereby researchers can be authorized to obtain a restricted drug for scientific purposes, including for the purpose of clinical trials evaluating the safety and efficacy of restricted drugs.
• New Classes of Practitioners Regulations (NCPR): Made under the CDSA, the NCPR expand the definition of practitioner under the CDSA to include midwives, nurse practitioners and podiatrists so that they are authorized to conduct activities, including the prescribing of marketed drugs containing a controlled substance, in accordance with the NCR, the BOTSR and the FDR-G (with the exclusion of certain controlled substances).
• The Regulations Exempting Certain Precursors and Controlled Substances from the Application of the Controlled Drugs and Substances Act (Exemption Regulations) came into force at the same time as the CDSA. The objective of the Exemption Regulations was to exempt certain precursors and controlled substances from the application of the CDSA until such a time as they could be scheduled under regulations. While most of the precursors and controlled substances have since been removed from the Exemption Regulations, three substances remain. Of these, two (bezitramide and piritramide) are opioids, and both are scheduled internationally. While currently there are no approved drugs containing these substances in Canada, it is possible that such drugs may be available in the future since they are marketed in other countries. Thus it is proposed that both of these substances be added to the new schedule in the proposed CSR for narcotics, thus ensuring that they are subject to the CDSA and its regulations moving forward. The third substance, propylhexedrine, was previously scheduled internationally, but was removed from Schedule IV of the 1971 Convention in 1991. This substance would remain uncontrolled in Canada.

Legitimate activities with controlled substances can be authorized either through regulations or exemptions issued pursuant to section 56 of the CDSA. In order to address situations not captured by the regulations, Health Canada has issued class exemptions, including the following:

• Section 56 Class Exemption For Travellers Who Are Importing or Exporting Prescription Drug Products Containing a Narcotic or a Controlled Drug: Modelled after relevant provisions in the BOTSR, this exemption allows travellers to come into and depart from Canada with prescription drugs containing cannabis, a narcotic, or a controlled drug for their medical use.
• Subsection 56(1) Class Exemption for Pharmacists, Practitioners, Persons in Charge of a Hospital and Licensed Dealers for the Provision and Destruction of Unserviceable Stock and Post-consumer Returns: This exemption authorizes pharmacists, practitioners and hospitals to destroy controlled substances and cannabis on-site or to send them to a licensed dealer for the purpose of destruction. This exemption also permits individuals to take a prescription drug containing a controlled substance or cannabis to a retail pharmacy for the purpose of destruction.
• Subsection 56(1) class exemption for patients, practitioners and pharmacists prescribing and providing controlled substances in Canada: Originally issued in response to the COVID-19 pandemic, this exemption expands certain authorities set out in the regulations under the CDSA with respect to the practice of pharmacists, such as prescribing and selling a controlled substance to a patient in order to extend or renew an existing prescription, and allowing practitioners to verbally prescribe any controlled substance.
• Subsection 56(1) class exemption for practitioners, agents, pharmacists, persons in charge of a hospital, hospital employees, and licensed dealers to conduct activities with psilocybin and MDMA in relation to a special access program authorization: Health Canada’s Special Access Program (SAP) allows practitioners to request access to drugs that have shown promise in clinical trials or have been approved in other countries, but that have not been authorized for sale in Canada. This program provides access to non-marketed drugs for the emergency treatment of patients with serious or life-threatening conditions in instances where conventional therapies have failed, are unsuitable or are unavailable. The ability for health care practitioners to request access to restricted drugs such as N-methyl-3,4-methylenedioxyamphetamine (MDMA) and psilocybin through the SAP was restored in January 2022 through regulatory amendments to Part C of the Food and Drug Regulations (FDR). This exemption authorizes the relevant regulated parties mentioned above to conduct activities with psilocybin and MDMA if the sale of the drug has been authorized through the SAP for the emergency treatment of a patient.
• Subsection 56(1) Class Exemption for Certain Practitioners to Administer Designated Drugs for Therapeutic Use: This exemption enables practitioners of medicine, dentistry or veterinary medicine and nurse practitioners to administer a prescription medication containing a designated drug (a term defined in the FDR-G referring to amphetamine, benzphetamine, methamphetamine, phenmetrazine and phendimetrazine) to a patient under their professional treatment if they decide the designated drug is required for the condition for which the patient is receiving treatment.
• Subsection 56(1) Class Exemption for Nurse Practitioners to Prescribe Anabolic Steroids for Therapeutic Use: This exemption enables nurse practitioners to prescribe and possess a prescription medication containing an anabolic steroid other than testosterone, provided this is allowed under their provincial scope of practice.

Recognizing the need to modernize the regulations for controlled substances to improve the administration of and compliance with the regulations, Health Canada started a strategic regulatory modernization initiative with a view to modernizing, harmonizing and eventually consolidating the above-mentioned regulations. As a first step, Health Canada modernized the licensing and permitting scheme in the NCR, the BOTSR, the FDR-G and the FDR-J in 2019. Subsequently, Health Canada conducted public consultations on certain aspects of the regulations, such as individuals travelling with controlled substances, and provisions pertaining to pharmacists and test kits. Health Canada is now proceeding with the consolidation of the above-mentioned regulations.

Legislative framework for cannabis

The Cannabis Act and the Cannabis Regulations create a framework for the legal production, distribution, sale and possession of cannabis in Canada. When the legislation came into force in 2018, cannabis was removed from under the CDSA and the NCR, and placed under the Cannabis Act and the Cannabis Regulations.

Since legitimate activities with cannabis were previously regulated under the NCR, provisions in the Cannabis Regulations on drugs containing cannabis and test kits were modelled after certain provisions of the NCR.

In accordance with transitional provisions under the Cannabis Act, the Section 56 Class Exemption for Travellers Who are Importing or Exporting Prescription Drug Products Containing a Narcotic or a Controlled Drug applies to prescribed drugs containing cannabis (e.g. Sativex and Epidiolex) and controlled substances until this exemption expires or is revoked. It is important to note that it remains illegal to take other cannabis, such as cannabis products and cannabis for medical purposes, across the Canadian border. The Subsection 56(1) Class Exemption for Pharmacists, Practitioners, Persons in Charge of a Hospital and Licensed Dealers for the Provision and Destruction of Unserviceable Stock and Post-consumer Returns also applies to controlled substances and cannabis until this exemption expires or is revoked.

Objective

The objectives of this regulatory proposal are

• To further improve the administration of and compliance with the regulations by harmonizing, consolidating and modernizing provisions in the current regulations for controlled substances and by improving alignment between the Cannabis Regulations and the proposed CSR;
• To support pharmacy innovation in Canada and enable pharmacists and pharmacy technicians to more fully use their expertise as medication experts; and
• To further enhance the clarity and readability of the regulations by consolidating and improving alignment across the regulatory frameworks for controlled substances, drugs containing cannabis, and test kits containing a controlled substance or cannabis with the application of up-to-date legislative drafting conventions.

Description

Controlled Substances Regulations

With a view to maintaining and modernizing the regulations for controlled substances, the proposed CSR have been drafted with the following approach:

• Consolidating the current regulations into one new set of regulations for controlled substances, while harmonizing provisions as needed, and streamlining and removing out-of-date provisions where appropriate;
• Incorporating authorizations granted through the section 56 class exemptions listed in the “Background” section above;
• Creating new provisions to address gaps and issues identified by Health Canada and through public consultations; and
• Applying up-to-date legislative drafting conventions.

The proposed CSR would contain the following parts.

Interpretation

This part contains definitions for terms used in the regulations. Most of the definitions are consolidated from the current regulations; however, new definitions are also provided with respect to certain terms now used in the proposed CSR and to enhance clarity and improve readability of the regulatory text. For example, in addition to definitions for categories of controlled substances, definitions are added for finished products and mixtures, to improve clarity with respect to requirements that apply to forms of products that contain controlled substances.

General

Consolidating and streamlining provisions in the current regulations, this part contains a provision regarding non-application for members of a police force and a provision regarding non-application for agricultural implants containing anabolic steroids (which are regulated as veterinary drugs under the FDR). For greater clarity, this part also includes a provision setting out authorizations and requirements for agents and mandataries of a person regulated under the proposed CSR.

Possession

Because the possession of controlled substances listed in Schedules I, II and III of the CDSA is prohibited unless authorized, this part consolidates provisions in the current regulations that provide authorizations for regulated persons such as licensed dealers, pharmacists, practitioners, and hospitals, as well as members of a police force, certain government employees, persons exempted under subsection 56(1) of the CDSA, and other authorized individuals to legally possess such substances.

Licensed dealers

This part sets out a licensing scheme governing the activities conducted by producers, distributors, importers and exporters with controlled substances. As the part related to licensed dealers was streamlined and modernized in 2019, provisions regarding licensed dealers in the proposed CSR would remain largely the same in comparison with those of the current regulations. The following key elements of this part would remain unchanged:

• With specified eligibility, a business or individual must obtain a licence to produce, sell or provide to other regulated or exempted parties, import, export, send, deliver and transport controlled substances.
• Only licensed dealers can import or export controlled substances; to do so, they must first obtain an import or export permit.
• A licensed dealer must comply with requirements with respect to responsible personnel, record-keeping, security for storage and during transportation, and reporting on regulated activities and loss or theft. Non-compliance may result in the suspension or revocation of their licence or permit.
• This part sets out circumstances in which a licensed dealer may destroy a controlled substance.

Additional regulatory changes are being proposed, including the following:

• Instead of requiring that a licensed dealer report unexplainable losses of controlled substances to both a member of a police force and Health Canada, as in the current regulations, the proposed CSR would require a licensed dealer to report such losses only to Health Canada. As is currently the case, the proposed CSR would require licensed dealers to report thefts to both police and Health Canada.
• The current regulations require annual reports on regulated activities, even though in practice such reports are provided monthly. To align the regulations with current practice, the proposed CSR would require that such reports be submitted monthly.
• Further to the authorization in the current regulations that allows a licensed dealer whose licence permits them to do so to sell or provide a restricted drug to a researcher, the proposed CSR would allow them to sell or provide a restricted drug to a practitioner if a letter of authorization has been granted by Health Canada’s SAP in accordance with section C.08.010 of the FDR.
• Adding to the existing requirements with respect to record-keeping, the proposed CSR would establish a simplified record-keeping requirement for controlled substances returned by an individual to a pharmacy as set out in the class exemption regarding destruction by health care professionals. A licensed dealer would not need to record information such as name and quantity of the returned controlled substance prior to its destruction.
• The current regulations require designated responsible personnel to provide proof of a criminal record check conducted by a police force. The proposed CSR would allow the submission of proof of a criminal record check conducted by a fingerprinting service that is accredited to reflect the fact that such companies are now accredited by the Royal Canadian Mounted Police for conducting criminal record checks and issuing reports.
• The proposed CSR would require additional information on a permit application with respect to the shipment, such as proposed port of entry/exit and mode of transportation, so that Health Canada could conduct a better informed review of the application.
• Finally, further to the authorization in the current regulations that allows a pharmacist or hospital to return a controlled substance to the licensed dealer who sold or provided it or to a licensed dealer who is specialized in destruction, the proposed CSR would authorize a pharmacist, practitioner or hospital to sell or provide a controlled substance to any licensed dealers (for purposes such as return or destruction).

Pharmacists

As with the current regulations, this part sets out circumstances in which pharmacists may conduct activities with controlled substances (other than restricted drugs). This part is not applicable to pharmacists working in a hospital. As is currently the case, pharmacists working in a hospital would be considered hospital employees who must conduct activities with controlled substances in compliance with the provisions in the part for hospitals.

By consolidating relevant provisions in the current regulations, the proposed CSR would continue to authorize a pharmacist to, among other activities,

• Sell or provide a controlled substance to a patient pursuant to a prescription issued by a practitioner;
• Sell or provide a controlled substance to a person exempted in accordance with subsection 56(1) of the CDSA, provided the exemption contemplates the sale or provision;
• Sell a controlled substance to another pharmacist for emergency purposes;
• Sell or provide a controlled substance to a hospital; and
• Return a controlled substance to a licensed dealer who sold or provided the substance to the pharmacist.

For consistency and where appropriate, the proposed CSR would contain more detailed requirements regarding record-keeping, protective measures and reporting of losses or thefts, as well as provisions regarding restrictions on sale under specified circumstances. Modelled after relevant provisions in the BOTSR, the proposed CSR would further authorize a pharmacist to compound, send, deliver and transport a controlled substance to a patient pursuant to a prescription, sell or provide a controlled substance to a practitioner or the Minister, and transfer a prescription to another pharmacist.

The proposed CSR would also incorporate authorizations for pharmacists conducting certain activities currently permitted pursuant to certain subsection 56(1) class exemptions, such as extending a prescription issued by a practitioner, destroying a controlled substance on site or sending such products to a licensed dealer who is specialized in destruction.

In addition to the above, the proposed CSR would allow a pharmacist to sell or provide a controlled substance to another pharmacist for the purpose of filling a prescription. This authorization would provide additional flexibility with respect to how prescriptions are filled and would enable models such as central fill services for controlled substances.

Finally, in response to stakeholders’ requests, the proposed CSR would also authorize a pharmacy technician to independently conduct many of the activities that a pharmacist is authorized to conduct. This would enable pharmacy technicians to independently conduct certain activities with controlled substances in accordance with their scope of practice. These authorized activities would include compounding, sending, delivering or transporting a controlled substance, transferring a prescription to a pharmacist or another pharmacy technician, or destroying a controlled substance on site. Similar to pharmacists, pharmacy technicians would assume the legal responsibility to comply with requirements on record-keeping and security for storage and during transportation. It is proposed that only pharmacists would be authorized to independently conduct the activities of selling and providing controlled substances (on the current understanding that overall oversight for these activities would rest with the pharmacist rather than the pharmacy technician).

Practitioners

This part sets out circumstances in which “practitioners,” as defined in the CDSA and prescribed in the proposed CSR (currently: physicians, dentists, veterinarians, nurse practitioners, midwives and podiatrists), could conduct activities with controlled substances, similar to the current regulations.

By consolidating the current regulations, the proposed CSR would continue to authorize a practitioner to prescribe, administer, sell or provide a narcotic, controlled drug or targeted substance to a patient who is under their professional care.

In addition, the proposed CSR would contain more detailed requirements regarding record-keeping, protective measures and reporting of losses or thefts. Modelled after provisions in the BOTSR that apply to targeted substances, the proposed CSR would also authorize a practitioner to send, deliver and transport a narcotic or controlled drug to a patient, and to sell or provide a controlled substance to a licensed dealer or the Minister.

The proposed CSR would also incorporate authorizations for practitioners conducting certain activities currently allowed through subsection 56(1) class exemptions, such as verbally prescribing any controlled substance, destroying a controlled substance on site or sending it to a licensed dealer who is specialized in destruction, or administering, selling or providing a restricted drug to a patient if the sale of the restricted drug has been authorized under the SAP in accordance with section C.08.010 of the FDR.

Paragraph G.04.001(3)(a) of the FDR-G limits the administration of “designated drugs” by practitioners to certain indications only (e.g. hyperkinetic disorders in children), despite additional authorized uses and off-label uses. A subsection 56(1) class exemption was put in place in 2023, which allows doctors of medicine, dentistry, or veterinary medicine and nurse practitioners to prescribe designated drugs for therapeutic use without any limitations. Consistent with this class exemption, the proposed CSR do not include any limits on how these drugs can be prescribed.

Hospitals

As with the current regulations, this part sets out circumstances in which hospitals, including pharmacists or practitioners as employees working in a hospital, can conduct activities with controlled substances (other than restricted drugs).

By consolidating the current regulations, the proposed CSR would continue to authorize a person in charge of a hospital to permit the following activities with controlled substances in that hospital:

• Administration of a controlled substance to a patient pursuant to a prescription issued by a practitioner;
• Selling or providing a controlled substance to a patient pursuant to a prescription;
• Selling or providing a controlled substance to a pharmacist or another hospital for emergency purposes; and
• Selling or providing a controlled substance to a person exempted in accordance with subsection 56(1) of the CDSA.

In addition, the proposed CSR contain provisions that would contain more detailed requirements regarding record-keeping, protective measures and reporting of losses or thefts. Modelled after provisions in the BOTSR, the proposed CSR would authorize a hospital to sell or provide a controlled substance to a practitioner for emergency purposes, a licensed dealer or the Minister, and to send, deliver and transport a controlled substance.

The proposed CSR would also allow hospitals to conduct certain activities by incorporating authorizations for a person in charge of a hospital conducting certain activities currently granted through subsection 56(1) class exemptions such as destroying a controlled substance on site or sending it to a licensed dealer who is specialized in destruction.

To align with the authorized activities for pharmacists in the pharmacists part described above, this part would authorize the person in charge of a hospital to allow compounding of controlled substances in the hospital.

For improved clarity and readability, the proposed CSR would include a new definition for person in charge of a hospital and a new provision setting out the following persons who can conduct activities with controlled substances if allowed by the person in charge of a hospital:

• Health care professionals in accordance with their scope of practice; and
• Other hospital employees in accordance with their duties and functions.

Minister

Modelled after provisions in the current regulations, this part would authorize the Minister to communicate factual information that has been obtained under the CDSA or the proposed CSR about a pharmacist, pharmacy technician, practitioner or any other health professional to the provincial professional licensing authority that is responsible for the authorization of the person to practise their profession.

Under the CDSA, the Minister has the authority to temporarily schedule a substance of concern for a period of one year, through a pathway known as the temporary accelerated scheduling pathway. This involves listing the substance in Schedule V to the CDSA. During the period of time the substance is temporarily scheduled, this part would also give the Minister the authority to provide, by order, that the substance is to be regulated as a restricted drug, thereby providing a pathway to enable any legitimate activities with the substance.

Consistent with regulations such as the Cannabis Regulations and the Precursor Control Regulations, the proposed CSR would include the following new provisions:

• Authorize the Minister to communicate certain information collected under the regulations with a customs officer, the International Narcotics Control Board and foreign competent authorities to mitigate the risk of diversion and fulfill Canada’s international obligations under the United Nations drug control conventions; and
• Authorize the Minister to partially suspend a licence with respect to any activities with controlled substances.

Individuals

This part would authorize an individual to sell, provide, import, export, send, deliver or transport a controlled substance under certain circumstances.

Modelled after provisions in the BOTSR and incorporating the section 56 class exemption, which currently allows individuals to import or export prescription drugs containing cannabis, a narcotic or a controlled drug when entering or leaving Canada, the proposed CSR would authorize an individual to import or export a prescription drug containing a controlled substance that has been prescribed to them for their personal use at the time of entering or leaving Canada. The proposed new authorization would allow for up to a 90-day supply of the prescription drug to be imported or exported, which is longer than the 30 days that applies currently for narcotics and controlled drugs as set out in the section 56 class exemption, but consistent with the provisions in the BOTSR that apply to targeted substances.

The proposed CSR would also incorporate authorizations to conduct activities that are currently permitted through subsection 56(1) class exemptions, namely, allowing an individual to bring a controlled substance to a retail pharmacy for its destruction, and delivering a prescription drug containing a controlled substance to a patient on behalf of a pharmacist.

Test kits

As with the current regulations, this part would exempt certain activities from the application of the proposed CSR with respect to test kits.

While streamlining provisions in the current regulations, the proposed CSR sets out the same scheme under which, with a registration number issued by Health Canada, any person could sell, provide, import, export, send, deliver or transport a test kit.

In addition, similar to paragraph 9(2)(b) of the BOTSR, the proposed CSR would provide further clarity regarding the permitted activities with a test kit that may continue in the situation where Health Canada has cancelled the registration number upon request by the registration number holder. These provisions would make it clear that any test kits remaining after the cancellation of the registration number can continue to be sold, imported and exported.

Miscellaneous provisions

As in the current regulations, this part contains a provision which would prohibit advertising of a controlled substance to the general public and imposes restrictions on such advertising to regulated parties (i.e. a licensed dealer, pharmacist, pharmacy technician or practitioner). This part also contains a provision that outlines the prior notification requirements in the case where an application to a justice is being made by a person whose controlled substance was seized or acquired in accordance with the CDSA for the return of that substance pursuant to subsection 24(1) of the CDSA.

Coming into force and repeal

The proposed CSR would come into force 365 days after the day they are published in the Canada Gazette, Part II, to provide an appropriate transition period. On the day the proposed CSR would come into force, the NCR, the BOTSR, the FDR-G, the FDR-J, the NCPR and the Exemption Regulations, along with the above-mentioned section 56 class exemptions, would be repealed or revoked, as the case may be.

Schedules

Currently, each of the NCR, BOTSR, FDR-G, and FDR-J include a schedule with one or more parts. Substances listed in the schedule to the NCR, for instance, are considered “narcotics.” Under the proposed CSR, there would continue to be separate schedules for the different categories of controlled substances, as follows:

• Schedule 1 — Narcotics
• Schedule 2 — Controlled Drugs (Part 1, Part 2 and Part 3)
• Schedule 3 — Targeted Substances
• Schedule 4 — Restricted Drugs (Part 1, Part 2 and Part 3)

Additional changes

It is proposed that the following provisions in the current regulations would not be included in the proposed CSR, either because they do not align with the best available scientific evidence or because they are redundant.

Restrictions on activities with diacetylmorphine in the NCR

The NCR authorize a doctor of medicine or nurse practitioner to prescribe, administer, sell or provide diacetylmorphine and restrict a dentist or veterinarian to conducting activities with diacetylmorphine only in a hospital setting. This restriction was established based on the approved indications for this narcotic and an assessment of the risks posed by diacetylmorphine to public health and public safety at the time. No such restrictions exist in the NCR for other narcotics, such as fentanyl, which is more potent than diacetylmorphine. This is an example of where the regulations have not kept pace with the best available science or the approved indications for this narcotic. The intent of removing these restrictions is not to expand access to diacetylmorphine. It is proposed that the current restriction on midwives and podiatrists prescribing diacetylmorphine would be maintained.

Prescribing of certain controlled substances by nurse practitioners

Currently, the NCPR do not permit nurse practitioners to prescribe opium, coca leaves or anabolic steroids (except testosterone). The proposed CSR would not contain any such restrictions for nurse practitioners, in much the same way that no such restrictions apply to physicians, veterinarians and dentists. Restrictions on prescribing opium and coca leaves are not needed since the practitioners can only prescribe marketed drugs. Furthermore, consistent with the subsection 56(1) class exemption authorizing nurse practitioners to conduct activities with any anabolic steroid within their scope of practice, the proposed CSR would not restrict the prescribing of anabolic steroids by nurse practitioners. Of note, since the NCPR were put in place in 2012, two additional marketed drugs containing anabolic steroids have been authorized by Health Canada. This is another example of where the regulations have not kept pace with the best available science or approved indications for this category of drugs.

Provisions in the NCR and the FDR-G regarding analysis and identification of controlled substances by practitioners

Available information shows that these provisions have not been used for decades and are no longer relevant.

Requirement in the BOTSR with respect to permits for transit and transhipment of targeted substances

Since the BOTSR came into force in 2001, no permit has been requested nor issued under this provision; therefore, this provision is no longer relevant. Note that in the Canadian context, a transhipment is considered to be “importation.”

Part J research authorization for restricted drugs

Currently, most research with controlled substances is authorized through subsection 56(1) exemptions. Restricted drugs are an exception to this, in that the FDR-J requires an institution or researcher to request an authorization from the Minister in order to obtain a restricted drug for scientific purposes. These two separate authorization schemes for research with controlled substances create confusion for both applicants and the regulator. In the case of a researcher requiring different categories of controlled substances for one research project, they may have to obtain authorizations through separate procedures. Removing the FDR-J research authorization pathway means that subsection 56(1) would be the mechanism by which Health Canada would authorize researchers to obtain any controlled substances for scientific purposes. In the future, Health Canada will consider developing an alternate authorization scheme that would apply to research with controlled substances.

Notice of prohibition of sale

The NCR, the BOTSR and the FDR-G provide the Minister with the authority to restrict the sale of a controlled substance to a pharmacist or practitioner who requests such a restriction or who is not in compliance with the CDSA regulations or provincial professional licensing practice requirements. Over the years, all notices were issued at the request of provincial licensing authorities that have a similar and more effective mechanism as part of their health professional practice monitoring system. Usually, the notices issued by Health Canada in accordance with these provisions are not as comprehensive and timely in comparison with the restrictions imposed by provincial licensing authorities. Health Canada has identified that the notice of restriction in the current regulations is redundant and proposes it be removed.

Test kits that are subject to the CDSA regulations as well as the Medical Devices Regulations (MDR) as in vitro diagnostic devices

Under the current regulations, a test kit registration number must be cancelled if its authorization as a medical device is revoked under the MDR. Given that the current regulations and the MDR regulate test kits from different perspectives (prevention of diversion and inappropriate use vs. quality control), revoking an authorization for a test kit under the MDR may not necessarily provide the proper grounds for the cancellation of the test kit registration number issued under the current regulations. Therefore, authorization revocation under the MDR would not be reflected in the proposed CSR as grounds for the test kit registration number cancellation under the CDSA by the Minister.

Possession authorization provisions for persons exempted in accordance with subsection 56(1) of the CDSA in the current regulations

These provisions are redundant as possession is already authorized when a subsection 56(1) exemption is issued.

Schedule II of the BOTSR

Schedules I and II of the BOTSR contain the same information with respect to targeted substances, but Schedule II refers to the name of a substance as “specified name.” With no differences between the two schedules and with Schedule II adding no value, it is proposed that Schedule II not be maintained.

Regulations Amending Certain Regulations Concerning Controlled Substances

Consequential and coordinating amendments to the following regulations are needed to replace references to the current regulations with reference to the proposed CSR and to ensure consistency between regulations:

• Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations
• Fees in Respect of Dealer’s Licences Regulations
• Food and Drug Regulations
• Medical Devices Regulations
• Precursor Control Regulations

Regulations Amending the Cannabis Regulations (Harmonization with Certain Provisions of the Controlled Substances Regulations)

Consequential and coordinating amendments would also be made to the Cannabis Regulations, in particular in Part 8 (Drugs Containing Cannabis) and Part 13 (Test Kits).

Test kits containing cannabis

Relevant provisions would be amended to make a series of changes to support continued alignment with certain requirements pertaining to test kits under the proposed CSR.

Drugs containing cannabis

Amendments would be made to certain provisions to

• Ensure consistent use of the terms “prescription drug,” “drug containing cannabis,” “name,” “brand name,” “common name,” “proper name,” “attestation,” and “declaration”;
• Expand authorities to allow pharmacists, practitioners, and hospitals to sell and distribute drugs containing cannabis for the purpose of destruction to all licensed dealers^{footnote 1} (currently these parties are only authorized to distribute drugs containing cannabis to licensed dealers specialized in destruction) and introduce corresponding record-keeping requirements to enable review and compliance activities conducted under these expanded authorizations;
• Expand authorities to allow licensed dealers who are not specialized in destruction to possess, distribute and sell drugs containing cannabis in certain circumstances, and introduce corresponding record-keeping requirements to enable review and compliance activities;
• Allow pharmacists to sell and distribute prescription drugs containing cannabis to another pharmacist for the purpose of filling a prescription to enable services such as central fill services, and for the purpose of depleting stock in certain circumstances (e.g. closure of pharmacy). Corresponding record-keeping requirements would be introduced to enable review and compliance activities;
• Improve alignment between the Cannabis Regulations and the proposed CSR with respect to requirements for witness qualifications for on-site destruction by licensed dealers specialized in destruction; and
• Introduce a requirement for cannabis licence holders and licensed dealers to record the drug identification number (DIN) for prescription drugs containing cannabis when they conduct certain activities with these drugs (e.g. import, export, sale, distribution) to support review and compliance activities. Recording a DIN would not be required for the destruction of these drugs.

Unlike the proposed CSR, the Cannabis Regulations would not be amended to authorize activities specifically for pharmacy technicians. This is because a pharmacy technician can already be authorized under the Cannabis Act to conduct activities with drugs containing cannabis as an agent, mandatary or employee of a pharmacist.

Destruction of cannabis that an individual brings to a pharmacist

In alignment with the proposed CSR, the Cannabis Regulations would be amended to authorize an individual to distribute cannabis to a pharmacist for the purpose of destruction under certain circumstances. Pharmacists would also be authorized to possess cannabis provided by an individual for the purpose of destruction, by considering cannabis received by a pharmacist to be a controlled substance for the purpose of its destruction only. This way, a pharmacist would be authorized to either destroy this cannabis on site or sell or provide it to a licensed dealer specialized in destruction. This change would maintain authorizations with respect to cannabis that are currently granted through the subsection 56(1) class exemption for post-consumer returns that would be revoked upon the coming into force of the proposed CSR.

Individuals importing or exporting drugs containing cannabis for personal medical use

The Cannabis Regulations would also be amended to authorize individuals to travel with up to a 90-day supply of prescribed drugs containing cannabis (e.g. Sativex or Epidiolex) for personal medical use subject to specific requirements. Note that under the Cannabis Act, it remains illegal for an individual to enter Canada or leave Canada with other cannabis, such as cannabis products and cannabis for medical purposes. This change would maintain authorizations currently granted through the section 56 class exemption for travellers that would be revoked upon the coming into force of the proposed CSR, and would improve alignment with the proposed CSR.

Other changes

The Cannabis Regulations would be amended to replace references to the Narcotic Control Regulations with references to the “former Narcotic Control Regulations” or the proposed CSR, as appropriate, following the repeal of the NCR. The Cannabis Regulations would also be amended to clarify certain wording, better align English and French terms, and improve readability without substantively changing requirements (e.g. clarify wording on qualification requirements for the position of qualified person in charge and define the term “drug identification number”).

Regulatory development

Consultation

Health Canada has consulted stakeholders on a series of notices of intent related to certain portions of this regulatory proposal since 2017.

These notices related to the destruction of controlled substances by health care professionals and hospitals, test kits, and provisions pertaining to pharmacists. Feedback received in response to those consultations was generally supportive. In particular, stakeholders indicated that regulations made under the CDSA should enable pharmacists to fully practise their profession, that pharmacy technicians should be authorized to independently conduct certain activities with controlled substances, and that central fill services should be enabled.

In addition, certain gaps in the current regulations identified by stakeholders have previously been addressed through subsection 56(1) class exemptions. Stakeholders have generally noted that the exemptions have had positive impacts and have helped Health Canada identify areas that need to be further addressed in regulations. For instance, pharmacists, pharmacist associations, provincial regulatory authorities for pharmacists and some provincial governments have expressed strong support for the subsection 56(1) class exemption authorizing, among other things, pharmacists to conduct additional activities with controlled substances.

During the development of this regulatory proposal, Health Canada has consulted on multiple occasions with targeted stakeholder groups to solicit their views on issues that the proposed CSR would address, in particular with respect to the practice of pharmacists. Input by these groups was considered by Health Canada to inform approaches to address relevant issues in the proposed CSR.

Health Canada acknowledges that some of the feedback received from pharmacy stakeholders in particular has not been fully addressed, as further consultations and analysis of impacts are needed. Health Canada is committed to undertaking additional consultations with health care professionals and associations, including pharmacist stakeholders, as well as provinces and territories, on provisions pertaining to practitioners and hospitals that will inform future regulatory amendments.

Modern treaty obligations and Indigenous engagement and consultation

The regulatory proposal would consolidate and modernize the existing regulatory framework for controlled substances and improve alignment between the Cannabis Regulations and the proposed CSR. While the proposed CSR would include amended or modernized provisions to respond to stakeholder comments and to reflect current practice by businesses and pharmacies, this regulatory proposal is aimed at all people in Canada and would not have any targeted impacts on any groups, including Indigenous groups. Similarly, the proposed amendments to the Cannabis Regulations would improve alignment with the proposed CSR and ensure clarity and consistency of provisions, but they would not specifically target Indigenous peoples. As part of its consultations with Canadians during the Canada Gazette, Part I, consultation period, Health Canada welcomes feedback from all impacted and interested stakeholders, including Indigenous peoples and organizations.

As per the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, a preliminary assessment of modern treaty implications has been conducted, which examined the geographical scope and subject matter of the regulatory proposals in relation to modern treaties in effect. The preliminary assessment did not identify any potential impact on the rights of Indigenous peoples recognized and affirmed under section 25 of the Constitution Act, 1982, and no impacts related to modern treaties with the Indigenous peoples of Canada are expected. The preliminary assessment concluded that the regulatory proposals would not trigger any modern treaty obligations, including a duty to consult with Indigenous peoples.

Instrument choice

To address the issues and to meet the objectives outlined above, it was determined that the only viable option would be to consolidate the implicated regulations and exemptions with necessary alignments and additional authorizations.

Maintaining the status quo or taking voluntary approaches were not considered to be viable options since the issues and gaps that resulted during the course of the long history of the development of regulations made under the CDSA would continue to pose challenges to Health Canada and regulated parties in terms of administration and compliance with the current regulations.

By also incorporating authorizations specified in various class exemptions, the streamlined and updated proposed CSR would provide a unified regulatory framework for all controlled substances. Covering all authorizations and requirements, the proposed CSR would enable Health Canada to better administer the regulatory regime and facilitate compliance with the proposed CSR by regulated parties, with reduced administrative burden and improved clarity and readability of the regulatory provisions.

Further, regulatory amendments are the only viable option to ensure that the Cannabis Regulations and other federal regulations that make reference to regulations for controlled substances remain aligned where necessary and that consistency across regulations is maintained.

Regulatory analysis

Summary of the cost-benefit analysis

The proposed CSR and the proposed amendments to the Cannabis Regulations would bring benefits to licensed dealers, pharmacists, holders of test kit registration numbers, researchers, individuals, and Health Canada. Most of the benefits would be in the form of time savings related to the initial examination of the proposed CSR and the reduced compliance and administrative burden to some regulated parties (e.g. licensed dealers, holders of test kit registration numbers, and pharmacists providing central fill services), as well as a reduction in activities by Health Canada to administer the proposed CSR. The present value (PV) of the total monetized savings to regulated parties and Health Canada is estimated to be $4.85 million over 10 years (or $690,035 in annualized value).

The proposed CSR and the proposed amendments to the Cannabis Regulations would also impose incremental administrative and compliance costs on regulated parties (e.g. licensed dealers, cannabis licence holders, and central fill pharmacies), albeit less significant compared to the benefits. These costs would mainly be related to time spent recording information and submitting notifications to Health Canada. Health Canada would also bear costs to implement the proposed CSR and proposed amendments to the Cannabis Regulations, such as for compliance promotion and providing training to inspectors. The total costs to regulated parties and Health Canada are estimated to be $4.09 million (PV) over 10 years (or $581,689 in annualized value). The proposed CSR and the proposed amendments to the Cannabis Regulations would result in a monetized net benefit of $0.76 million (PV) or an annualized net benefit of $108,346.

In addition to the monetized costs and benefits, the proposed CSR and the proposed amendments to the Cannabis Regulations would result in a number of unquantifiable benefits. By consolidating the current regulations and exemptions into one set of regulations governing all categories of controlled substances, the proposed CSR would increase harmonization, clarity and consistency of the regulatory requirements for all controlled substances, where appropriate. This is expected to reduce confusion and provide additional certainty to regulated parties and Health Canada, which would in turn contribute to greater compliance with the proposed CSR and facilitate their administration. In addition, regulated parties would save time during subsequent consultations of the proposed CSR as compared to doing so for multiple regulations and exemptions. Further, amendments to the Cannabis Regulations would improve harmonization between the regulatory approach taken for drugs containing cannabis and those containing a controlled substance. There would be additional non-quantifiable benefits to pharmacy technicians as they would be allowed to independently conduct most of the activities with controlled substances that are currently only enabled for pharmacists, as long as the activity is authorized under their scope of practice. There would also be benefits to people in Canada since certain activities (e.g. transporting controlled substances) would be formally authorized, and convenience would be improved for individuals travelling internationally with prescription drugs containing cannabis or a controlled substance as they would be authorized to carry up to a 90-day supply of these prescribed drugs during travel.

Analytical framework

A cost-benefit analysis was conducted to estimate the impacts of the proposed CSR and proposed amendments to the Cannabis Regulations on licensed dealers, cannabis licence holders, holders of test kit registration numbers, pharmacists and pharmacy technicians, practitioners, hospitals, researchers, individuals, provincial and territorial governments and professional regulatory authorities, and the Government of Canada. All identified costs and benefits were assessed by considering incremental impacts to affected parties that would only occur as a result of the proposed CSR and the proposed amendments to the Cannabis Regulations. It should be noted that authorizations and requirements that are already in place through the section 56 class exemptions (e.g. returning controlled substances to a pharmacy for destruction) that are being formalized through the proposed CSR would not result in any incremental impacts.

Health Canada sought information from selected stakeholders through questionnaires to validate assumptions and to collect additional data. The collected information was used in developing the cost-benefit analysis. All identified impacts are quantified and monetized to the extent possible. Where this is not possible due to data limitations or inability to make reasonable assumptions for quantification, the impacts are described qualitatively. Together, the monetized and non-quantified impacts provide a more accurate picture of the costs and benefits to stakeholders and allow for an adequate assessment of the net impact of the proposed CSR and the proposed amendments to the Cannabis Regulations.

All costs and benefits are estimated over 10 periods of 12 months commencing at the time of publication of the proposed CSR and the proposed amendments to the Cannabis Regulations in the Canada Gazette, Part II. The majority of these costs and benefits would start occurring during period 2, which corresponds to the year of coming into force. However, starting period 1, regulated parties would assume costs associated with reviewing the proposed CSR and the proposed amendments to the Cannabis Regulations, and pharmacists would experience some benefits related to the fact that they would no longer have to become a licensed dealer in order to provide central fill services. All incremental costs and benefits are expressed in constant 2022 Canadian dollars and are discounted to period 1 using a 7% discount rate. A copy of the cost-benefit analysis report is available upon request from csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca.

Benefits and costs

Benefits

The proposed CSR and proposed amendments to the Cannabis Regulations would result in a number of benefits to regulated parties, researchers, individuals who are prescribed drugs containing cannabis or a controlled substance, and Health Canada.

Benefits to all parties

Improved alignment, clarity and consistency of the regulations

There are currently different regulations that govern activities with the four categories of controlled substances. While these activities are similar, the regulatory requirements are not completely harmonized across these regulations, leading to confusion for many regulated parties with respect to interpreting the authorizations and the manner in which to comply with some of the regulatory requirements. To add further complexity, certain regulatory gaps that have been identified over the years have been addressed through the use of class exemptions provided in accordance with section 56 of the CDSA. The proposed CSR would result in the same authorizations and requirements being applied to activities with all categories of controlled substances, with some exceptions, and would clarify authorizations and requirements for agents/mandataries of regulated persons. This consolidation is expected to result in a more streamlined and efficient regulatory framework for controlled substances, thereby providing additional certainty and clarity for regulated parties, and facilitating compliance with the regulations. Similarly, the regulatory consolidation would help improve the administration of the regulatory scheme by Health Canada and other federal government departments.

Through the proposed CSR and the proposed amendments to the Cannabis Regulations, harmonization between the Cannabis Regulations and the regulations for controlled substances would be improved, further facilitating stakeholder compliance with the two regulatory regimes and removing unnecessary differences in regulatory requirements. For instance, the proposed CSR and the proposed amendments to the Cannabis Regulations would benefit licensed dealers by improving alignment of witness requirements for on-site destruction of drugs containing cannabis under the Cannabis Regulations with the witness requirements under the proposed CSR for destruction of controlled substances by a licensed dealer at the site specified in their licence. There would be additional benefits to certain regulated parties in the form of increased operational flexibility for pharmacists, practitioners, and hospitals, as they would be authorized to sell or distribute drugs containing cannabis (other than post-consumer returns) for the purpose of destruction to any licensed dealers.

Time saved reviewing one set of regulations instead of multiple regulations

There would be one-time cost savings to new regulated parties (e.g. a new licensed dealer or a new pharmacist) entering the market for controlled substances after the final publication of the proposed CSR because they would review the proposed CSR instead of the current regulations and applicable class exemptions. Considering that the length of the proposed CSR is less than that of the combined existing regulations and class exemptions, regulated parties would thus spend less time on reviewing the proposed CSR. The monetized benefits to regulated parties in time saved by reviewing and periodically consulting only one set of consolidated regulations are estimated to be $2.85 million present value (PV) or $405,914 annually.

In addition, from time to time, regulated parties spend time consulting the current CDSA regulations or the class exemptions to confirm their understanding of the requirements in relation to certain activities and implicated controlled substances. This practice is expected to continue over time. Therefore, going forward, regulated parties would save time as, instead of consulting multiple regulations and exemptions, they would consult only one set of modernized regulations.

Benefits to licensed dealers

Reduced administrative burden related to reporting losses and thefts

Licensed dealers would no longer be required to report unexplainable losses of controlled substances to a police force, though they would continue to report such losses to Health Canada. In addition, licensed dealers would no longer have to include unexplainable loss and theft information in their monthly reports.

According to Health Canada’s administrative data, on average per year, there are approximately 500 reports of unexplainable losses to police and about 60 licensed dealers that experience losses and thefts. It is assumed that 15 minutes and 20 minutes, respectively, would be spent on reporting one incidence of unexplainable loss to a police force and to record incidences of losses and thefts in a monthly report. Once the proposed CSR are implemented, the affected licensed dealers would no longer need to take these actions and would save the associated time. The monetized benefits to these regulated parties as a result of reducing this administrative burden are estimated to be $30,353 (PV) or $4,322 annually.

Economic benefit to licensed dealers providing third-party distribution service for drugs containing cannabis destined for destruction

Currently, licensed dealers specialized in destruction (but no other licensed dealers) are authorized to possess drugs containing cannabis for the purpose of destruction. The proposed amendments to the Cannabis Regulations would expand authorization for possession, distribution and sale of drugs containing cannabis that are unserviceable stock for the purpose of destruction to licensed dealers who are not specialized in destruction. This would benefit these licensed dealers, as they would be able to collect revenues from providing this service as intermediaries to both the sender (e.g. health professionals such as pharmacists) and licensed dealers specialized in destruction.

Benefits to holders of test kit registration numbers

Administrative savings associated with only notifying the Minister of modifications to test kits

Holders of test kit registration numbers for test kits containing a controlled substance would no longer need to go through the application process to request cancellation of an existing test kit registration number and issuance of a new one when they modify their test kits. They would only need to send a notification to the Minister regarding the changes. It is estimated that about five requests for cancellation and issuance of test kit numbers, on average per year, would be submitted and that 40 minutes would be spent to prepare and submit a request. With the proposed simplified process, 30 minutes would be saved, as a test kit holder would only spend 10 minutes to prepare and submit a notification to Health Canada. The monetized benefits to holders of test kit numbers for test kits containing a controlled substance as a result of this time saved is estimated to be $523 (PV) or $75 annually.

Economic benefit associated with continued sales of test kits that are no longer medical devices

There would be additional benefits to holders of test kit registration numbers, because the regulator would no longer be required to cancel the registration numbers issued under the CDSA or the Cannabis Act for test kits containing a controlled substance or cannabis that are medical devices when these test kits are no longer authorized for sale as a medical device under the MDR. This regulatory change would ensure those test kits could still continue to be sold and used as test kits despite no longer being authorized as a medical device. The modernized regulatory provisions would also clarify that when a test kit number is cancelled following a request from the holder as a result of ending manufacture or assembly of the test kit, the remaining stock of the test kits may continue to be sold until depletion. While there might be economic benefits to some holders of these registration numbers associated with continued sales of these test kits, these benefits cannot be quantified due to a lack of data.

Benefits to pharmacists and pharmacy technicians

Enabling pharmacy technicians to independently conduct certain activities with controlled substances

The proposed CSR would provide qualitative benefits to pharmacy technicians, as these health professionals would be allowed to independently conduct certain activities with controlled substances (e.g. deliver, send, transport, destroy, or compound), as long as it is authorized under their scope of practice. Pharmacy technicians can already conduct these activities under the supervision of a pharmacist. This change would be in line with their general scope of practice.

Providing central fill services without being licensed

Currently, pharmacists are authorized by their licensing authority to fill a patient-specific prescription on behalf of another pharmacist, pursuant to an order from the originating pharmacy. This business practice, known as centralized prescription processing (or central fill) services, benefits pharmacies who utilize this service, as it enables them to improve operational efficiency or reduce operational costs (stock keeping, processing time and related activities, etc.). This activity is currently not allowed for prescription drugs containing cannabis or a controlled substance, unless the pharmacy possesses a dealer’s licence under the CDSA regulations or a cannabis drug licence under the Cannabis Regulations. Otherwise, selling of prescription drugs containing cannabis or a controlled substance between pharmacists is authorized only in the case of an emergency.

As the proposed CSR and proposed amendments to the Cannabis Regulations would now authorize patient-specific non-emergency sales of prescription drugs containing cannabis or a controlled substance between pharmacists, effectively enabling central fill services for drugs containing cannabis or a controlled substance, the removal of these regulatory barriers would provide benefits to pharmacists providing central fill services, as they would no longer need to apply for or renew their licence and would save the associated costs. It is expected that there would be about 50 pharmacists providing central fill services for controlled substances in 2025, prior to the proposed CSR coming into force, and five new dealer’s licence applications from central fill pharmacies are expected each year. Over the 10 periods of analysis, about 80 pharmacists would save about 20 hours each from no longer needing to meet the regulatory requirements (applying or renewing their licence or meeting reporting requirements) associated with being a licensed dealer. The monetized benefits to pharmacists providing central fill services for controlled substances are estimated to be $1.46 million (PV) or $207,887 annually. While the benefits of allowing pharmacists to provide central fill services for prescription drugs containing cannabis are expected to be minimal, given the number of prescription drugs containing cannabis is extremely limited, the proposed amendments to the Cannabis Regulations would align these regulations with the proposed Controlled Substances Regulations by making it possible for central fill services to be used to fill prescriptions for all of these categories of prescription drugs moving forward.

It is also assumed that there are central fill pharmacists who would decide to provide central fill services for prescription drugs containing a controlled substance if it were not for the current obligation to first obtain a controlled substances dealer’s licence. With the removal of these regulatory barriers, it is anticipated that these pharmacists may now decide to take advantage of this business model. It is not possible to make reasonable assumptions on the number of such central fill pharmacies that would enter the market. Therefore, these potential parties are not accounted for in the estimates provided above.

Reduced administrative burden associated with pharmacy closures

Pharmacists would benefit from reduced administrative burden as they would no longer need to submit a notification to the Minister when they close their pharmacies and/or transfer controlled substances to another place or pharmacist. This would result in a saving of 10 minutes per avoided notification per affected pharmacist. In monetary terms, this time savings is estimated to be $15,293 (PV) or an annualized value of $2,177.

Benefits to researchers

Currently, researchers wishing to conduct activities with a restricted drug must apply for an authorization under the FDR-J and submit an institutional support letter as part of their application. Researchers applying for an exemption under subsection 56(1) of the CDSA in order to conduct activities with other categories of controlled substances do not need to submit an institutional support letter. The requirement to submit an institutional support letter places additional burden on researchers conducting activities with restricted drugs (and their institution) and requires researchers conducting activities with restricted drugs and another category of controlled substances to hold both an exemption and a Part J research authorization. The proposed CSR would not include a stand-alone authorization scheme for research associated with restricted drugs; instead, researchers would use the subsection 56(1) exemption pathway for authorization to conduct research with any controlled substances, including restricted drugs. This would address the inconsistency between the authorizations and would eliminate the extra burden to researchers associated with securing a support letter when conducting activities with restricted drugs. According to administrative data available to Health Canada, an average of 70 applications for authorizations for research with restricted drugs are submitted every year. It is assumed that since a researcher would still need to apply for an exemption, they would save the 30 minutes they usually spend on obtaining and submitting an institutional support letter as part of their application for authorization. The monetized benefits to researchers associated with the time saved is estimated to be $12,422 (PV) or $1,769 annually.

Benefits to individuals or patients

Additional flexibility during transport of medication containing controlled substances

Patients who need assistance transporting drugs containing a narcotic or a controlled drug may benefit from the explicit authorization that allows for another individual to possess and transport these drugs on their behalf. This would provide convenience for those patients who may need other people’s assistance while receiving treatment.

Reduced inconvenience and costs to international travellers

Currently, individuals travelling internationally (entering or exiting Canada) with prescribed drugs containing cannabis, a narcotic or a controlled drug can only carry a 30-day supply. This limitation is inconsistent with what is allowed for other prescription medications, which includes targeted substances, where an individual can carry a 90-day supply. As a result of this limit, individuals travelling internationally may need to find a prescriber who can provide a new prescription to ensure continuity of care while they are out of the country, and may bear additional expenses to do so. Some of these travellers have, in the past, requested an exemption under subsection 56(1) of the CDSA, in order to meet their medical needs while travelling outside of Canada for longer than 30 days. The proposed CSR and proposed amendments to the Cannabis Regulations would improve convenience to travellers by removing a regulatory barrier to possessing the quantity of a prescription drug containing cannabis, a narcotic or a controlled drug that is deemed necessary by their physician for the duration of their trip, enabling them to carry up to a 90-day supply. This would reduce the inconvenience and potential burden to international travellers, including the burden to apply for an exemption in situations where the traveller needs to carry up to a 90-day supply and would improve consistency with authorized quantities for targeted substances.

In addition, an individual travelling with an animal would be authorized to have, in their possession, quantities of prescription drugs containing cannabis, a narcotic or a controlled drug that have been prescribed for the animal. This would reduce the inconvenience of not having enough supply of the necessary medications and having to seek additional prescriptions for their animal when they arrive at their destination.

Benefits to the Government of Canada

Health Canada would also benefit from the clarity and consistency of the proposed CSR. This would improve the administration of the regulations and result in savings to the Department. More specifically, once the proposed CSR are published and implemented, it is expected that Health Canada would

• spend less time responding to stakeholder enquiries about topics such as central fill services or tracking during transportation of controlled substances;
• no longer be required to process individual subsection 56(1) exemption requests for carrying quantities of prescription drugs containing cannabis, a narcotic or a controlled drug for periods longer than 30 days, but not exceeding 90 days during travel, review institutional support letters as part of processing research authorization requests under the FDR-J, and process notices of pharmacy closures;
• no longer process applications to cancel the registration number and provide a new one for changes to test kits;
• no longer conduct pre-licence inspections of pharmacies planning to provide central fill services with controlled substances to other pharmacies;
• no longer issue or rescind notices of prohibition of sales; and
• spend less time on providing training to new inspectors.

The total monetized savings to Health Canada associated with the benefits outlined above are estimated to amount to $476,847 (PV) or $67,892 annually.

Costs

The proposed CSR and proposed amendments to the Cannabis Regulations would result in both compliance and administrative costs to regulated parties. Licensed dealers, cannabis licence holders, pharmacists and pharmacy technicians, practitioners, hospitals, and holders of test kit registration numbers would bear costs associated with time spent familiarizing themselves with the proposed CSR or the proposed amendments to the Cannabis Regulations, as applicable. In addition, certain regulated parties (e.g. licensed dealers, cannabis licence holders) would bear incremental costs associated with the requirements to record additional information such as the drug identification number (DIN) assigned to prescription drugs containing cannabis or a controlled substance, when these drugs are distributed, received, or sold by these regulated parties. Pharmacists would also bear some costs associated with recording information for central fill transactions. Provincial and territorial governments and regulatory authorities would also bear costs to update existing regulations, policies, bylaws and guidance documents under their purview to align with the proposed CSR and proposed amendments to the Cannabis Regulations. Health Canada and other federal agencies would bear incremental costs to implement and administer the updated regulatory frameworks for controlled substances and cannabis.

Costs common to all regulated parties

One-time cost to existing regulated parties associated with reviewing the proposed CSR and proposed amendments to the Cannabis Regulations

Existing regulated parties would spend time reviewing the proposed CSR and proposed amendments to the Cannabis Regulations and determining what they would need to do to ensure compliance. It is estimated that under normal circumstances, 1.5 minutes would be spent reviewing one page of regulatory provisions. It is assumed that businesses and professional regulatory authorities and associations would update guidance and other materials to facilitate review of regulations by their members, which would greatly reduce review time. The present value of the total costs to all regulated parties associated with reviewing the proposed CSR and proposed amendments to the Cannabis Regulations is estimated to be $3.10 million (or an annualized value of $441,112).

Costs to licensed dealers

Costs associated with obtaining approval of changes to record-keeping method

Sometimes, licensed dealers make changes to the method they use to record information they are required to record under the current regulations and exemptions. Under the proposed CSR, licensed dealers would need to seek approval from the regulator before amending their record-keeping methods. It is estimated that, on average, about 30 requests would be submitted by licensed dealers each year and the time associated with preparing and submitting the request would be 30 minutes. Therefore, the total cost is estimated to be $3,140 (PV) or an annualized cost of $447.

Cost associated with recording additional information

All licensed dealers would be required to record the DIN assigned to finished products as part of the information to be recorded regarding their activities with any finished products containing a controlled substance or prescription drugs containing cannabis, with the exception of destroying those drugs. They would also have to record the name and title of individuals involved in activities such as selling, distributing, ordering and transporting controlled substances, and the brand name and quantity for prescription drugs containing cannabis. As the required information is readily available to licensed dealers under their normal course of activities, the cost associated with recording this information is expected to be minimal. It is estimated that there will be 343 licensed dealers in the first period of analysis and this number is expected to increase by 12 every period thereafter. Each licensed dealer would spend two hours on recording additional information specified above. The total costs to these regulated parties are estimated to be $167,555 (PV) or $23,856 annually.

Regulatory costs associated with conducting activities with bezitramide and the class of piritramide

There are currently no known medical, commercial or industrial activities involving these synthetic opioids in Canada. The likelihood of these synthetic opioids being imported into Canada for legitimate activities, other than for research or forensic analysis, is extremely low. However, in the unlikely event that a business decides to conduct activities with these synthetic opioids in the future, the business would need to meet the requirements (i.e. apply for a new licence or amend their licence, apply for import and/or export permits, and meet reporting and recording requirements) under the proposed CSR, and bear any associated costs. While the potential for these costs to be assumed is acknowledged, they cannot be estimated due to lack of information and the very low likelihood of activities with these synthetic opioids taking place in the foreseeable future.

Costs to cannabis licence holders

Cost associated with recording additional information

Under the proposed amendments to the Cannabis Regulations, cannabis licence holders would be required to record the DIN for prescription drugs containing cannabis when they conduct certain activities (e.g. distribute, sell, or conduct research and development activities). Assuming all cannabis licence holders would spend time creating a total of 3 150 records per year and would each spend about 10 seconds recording the DIN, they would bear an estimated $1,192 (PV) or $170 in annualized value costs.

Costs to pharmacists

Record-keeping costs related to sales between pharmacies (central fill services)

There would be record-keeping requirements associated with the authorization for a pharmacist to sell prescription drugs containing cannabis or a controlled substance to another pharmacist, pursuant to a prescription (central fill services). Both parties to the transaction would be required to meet the applicable record-keeping requirements and would bear the related administrative costs. It is assumed that 5% of central fill pharmacies, which would not have otherwise provided central fill services for prescription drugs containing a controlled substance under the baseline scenario, would now provide central fill services for these drugs and would spend 24 hours a year recording information. It is also assumed that 7.5% of all central fill pharmacies would now provide central fill services for prescription drugs containing cannabis and would spend a maximum of two hours each per year on recording the required information. The total cost associated with meeting the record-keeping requirements to pharmacies involved in central fill services is estimated to be $111,506 (PV) over 10 years, or $15,876 annually.

Costs to researchers

Costs associated with seeking authorization for conducting research with bezitramide and the class of piritramide

Health Canada is not aware of any research activities being conducted currently by researchers with the two synthetic opioids proposed to be added to Schedule 1 (narcotics) to the proposed CSR. Should a researcher wish to conduct research with any of them in the future, they would need to apply for a subsection 56(1) exemption under the CDSA. This is the case for any researcher wishing to conduct research with any narcotic. While Health Canada does not expect to receive any requests in the foreseeable future, should a researcher decide to apply for an exemption, they would need to spend time to prepare and submit an application.

Costs to provincial governments and health professional licensing authorities

Updating regulatory and guidance materials

There would be costs to provincial/territorial governments as well as to health professional licensing authorities, as they would need to update relevant regulations, bylaws, policies or guidance materials to reflect the proposed CSR (i.e. making reference to the proposed CSR, updating references and guidance with respect to new or harmonized authorizations or requirements in the proposed CSR) and the proposed amendments to the Cannabis Regulations, and, where applicable, to consolidate these materials.

Costs to the Government of Canada

Processing applications

Health Canada would bear costs for processing notifications as well as applications from licensed dealers requesting the Minister’s approval to amend their method of record-keeping under the proposed CSR. It is assumed that the number of such applications would be limited to approximately 30 per year, and that it would take three hours to process each application. The costs to Health Canada for processing these requests are estimated to be $26,314 (PV) or $3,747 annually.

To implement and administer the proposed CSR and proposed amendments to the Cannabis Regulations, Health Canada would bear costs associated with updating forms and relevant subsection 56(1) class exemptions, developing training materials for inspectors and developing compliance promotion materials and other communication tools (e.g. updating websites). Health Canada would also bear costs for conducting compliance promotion activities to raise awareness of the new/amended regulatory requirements (e.g. providing compliance promotion and other communication materials to impacted and interested stakeholders, conducting outreach activities), updating internal documents (e.g. standard operating procedures, templates and guidance documents), inspection tools and databases, as well as providing training to Health Canada inspectors and members of implicated federal agencies (e.g. Canada Border Services Agency). The costs to Health Canada associated with these activities are estimated to be $677,649 (PV) over 10 years or $96,482 annually.

The total cost to Health Canada associated with these activities are estimated to be $703,963 (PV) over 10 years or $100,228 in annualized value. These incremental costs would be mainly attributable to the proposed CSR and would be absorbed through existing budgets; no additional funding would be required.

Net impact

Hospitals, cannabis licence holders, holders of test kit registration numbers, and Health Canada would experience net cost impacts as a result of the proposed amendments, albeit small. Overall, the proposed CSR would result in a net benefit of $0.76 million (PV) or an annualized net benefit of $108,346.

Cost-benefit statement

• Number of years: 10 periods of 12 months (2025–2026 to 2034–2035)
• Price year: 2022
• Present value base year: Period 1 (2025)
• Discount rate: 7%

Table 1: Monetized costs

Impacted stakeholders	Description of cost	Base year (Period 1)	Period 2	Period 10	Total (undiscounted)	Total (PV)	Annualized value
Licensed dealers	Reviewing the proposed CSR and proposed amendments to the Cannabis Regulations	$52,797	N/A	N/A	$52,797	$49,343	$7,025
	Requesting approval before amending record keeping method	N/A	$516	$516	$4,641	$3,140	$447
	Recording additional information (e.g. DIN)	N/A	$24,551	$31,240	$251,032	$167,555	$23,856
Cannabis licence holders	Reviewing the proposed amendments to the Cannabis Regulations	$44,014	N/A	N/A	$44,014	$41,135	$5,857
	Recording additional information (e.g. DIN)	N/A	$196	$196	$1,762	$1,192	$170
Pharmacists and pharmacy technicians	Reviewing the proposed CSR and proposed amendments to the Cannabis Regulations	$904,839	N/A	N/A	$904,839	$845,644	$120,401
	Recording central fill transactions	N/A	$18,313	$18,313	$164,815	$111,506	$15,876
Practitioners	Reviewing the proposed CSR and proposed amendments to the Cannabis Regulations	$2,201,658	N/A	N/A	$2,201,658	$2,057,625	$292,959
Hospitals	Reviewing the proposed CSR and proposed amendments to the Cannabis Regulations	$110,949	N/A	N/A	$110,949	$103,690	$14,763
Holders of test kits registration number	Reviewing the proposed CSR and proposed amendments to the Cannabis Regulations	$801	N/A	N/A	$801	$748	$107
Health Canada	Implementation, compliance and enforcement	$519,529	$68,238	$14,152	$808,627	$703,963	$100,228
All	Total costs	$3,834,587	$111,813	$64,416	$4,545,934	$4,085,541	$581,689

Table 2: Monetized benefits

Impacted stakeholders	Description of cost	Base year (Period 1)	Period 2	Period 10	Total (undiscounted)	Total (PV)	Annualized value
Licensed dealers	Spending less time on initial review of the regulatory provisions	$92,373	$94,607	$110,616	$1,015,238	$705,206	$100,405
	No longer reporting unexplainable losses to a police force	N/A	$4,297	$4,297	$38,675	$26,166	$3,725
	No longer reporting unexplainable losses and thefts in monthly reports	N/A	$688	$688	$6,188	$4,187	$596
Pharmacists and pharmacy technicians	Spending less time on initial review of the regulatory provisions	$40,480	$41,695	$53,181	$465,211	$321,284	$45,744
	Providing central fill service without a dealer’s licence	$92,900	$82,198	$219,174	$2,183,816	$1,460,113	$207,887
	Not spending time to inform Health Canada about their closures	N/A	$2,512	$2,512	$22,605	$15,293	$2,177
Practitioners	Spending less time on initial review of the regulatory provisions	$221,928	$229,935	$318,329	$2,656,176	$1,824,478	$259,765
Holders of a test kit registration number	Notifying the minister instead of requiring a new registration number for modified test kit	N/A	$86	$86	$774	$523	$75
Researchers	Simplified process for research authorization	N/A	$2,040	$2,040	$18,361	$12,422	$1,769
Health Canada	Reduction in administrative activities	$15,761	$75,894	$75,894	$698,805	$476,847	$67,892
All	Total benefits	$463,443	$533,951	$786,816	$7,105,848	$4,846,520	$690,035

Table 3: Summary of monetized costs and benefits

Impacts	Base year (Period 1)	Period 2	Period 10	Total (undiscounted)	Total (PV)	Annualized value
Total costs	$3,834,587	$111,813	$64,416	$4,545,934	$4,085,541	$581,689
Total benefits	$463,443	$533,951	$786,816	$7,105,848	$4,846,520	$690,035
Net impact	−$3,371,144	$422,137	$722,401	$2,559,914	$760,979	$108,346

Small business lens

Analysis under the small business lens concluded that the proposed CSR and proposed amendments to the Cannabis Regulations would impact a significant number of small businesses (e.g. licensed dealers, cannabis licence holders, pharmacies, and holders of test kit registration numbers). It is assumed that about 98% of affected businesses are small businesses. All businesses, including small businesses, would face incremental compliance and administrative costs associated with reviewing the regulatory requirements, recording and keeping records of information and submitting notifications or requests to the Minister for approving changes to record-keeping methods, as applicable. The total cost to small businesses for meeting these requirements are estimated to be $2.35 million (PV) or $334,203 annually. Although the total cost to small businesses is not small and is driven by the large number of affected small businesses, the cost per small business would be minor and is estimated at $119 (PV) per small business over 10 years or $17 annually.

Regardless of the magnitude of the cost impacts of the proposed CSR to small businesses, no flexibility can be provided to these businesses, as, in addition to spending time understanding the regulatory requirements, the main costs would be associated with additional record-keeping requirements, which are essential for the effective administration of the regulatory scheme.

In addition to the benefits associated with improved clarity and consistency of the regulatory requirements and the ability to conduct new authorized activities, the proposed CSR and proposed amendments to the Cannabis Regulations would also result in a reduction in burden to small businesses conducting activities with controlled substances, as they would no longer need to meet certain regulatory requirements or would spend less time reviewing and consulting regulations. These benefits are estimated to be $3.26 million (PV) or $463,626 annually. On average, each small business would save $165 (PV) or $23 annually. Overall, the proposed CSR and proposed amendments to the Cannabis Regulations would result in a net benefit to small businesses.

Overall, the net impact to small businesses would be a saving of $0.91 million (PV) or $129,423 annually. Per small business, the savings are estimated to be $46 (PV) or $7 annually.

Small business lens summary

• Number of small businesses impacted: 19 774
• Number of years: 10 periods of 12 months (2025–2026 to 2034–2035)
• Base year for the estimates: 2022
• Present value base year: 2025
• Discount rate: 7%

Costs to small businesses

Table 4: Compliance costs

Activity	Present value	Annualized value
Spending time to review the proposed CSR and proposed amendments to the Cannabis Regulations (not including provisions that impose administrative burden)	$837,783	$119,282

Table 5: Administrative costs

Activity	Present value	Annualized value
Spending time to review the proposed CSR and proposed amendments to the Cannabis Regulations (provisions that impose administrative burden only)	$1,256,675	$178,922
Submitting a request for Ministerial approval before amending record-keeping methods (controlled substances only)	$2,669	$380
Recording additional information items	$143,495	$20,430
Recording information for central fill transactions	$106,681	$15,189
Total costs	$1,509,520	$214,922

Table 6: Total compliance and administrative costs

Total	Present value	Annualized value
Total costs (all impacted small businesses)	$2,347,303	$334,203
Costs per impacted small business	$119	$17

Table 7: Benefits to small businesses ^{table c7 note a}

Activity	Present value	Annualized value
Spending less time to review the regulatory provisions	$1,769,813	$251,981
No longer reporting unexplainable losses to a police force	$22,241	$3,167
No longer reporting unexplainable losses and thefts in monthly reports	$3,559	$507
Providing central fill service without a dealer’s licence	$1,445,512	$205,808
Notifying the Minister instead of requiring new registration number for modified test kits	$52	$7
Not having to inform Health Canada about pharmacy closures	$15,141	$2,156
Total benefit (all impacted small businesses)	$3,256,318	$463,626
Benefit per impacted small business	$165	$23
Table c7 note(s) Table c7 note a Only for activities with controlled substances. Return to table c7 note a referrer

One-for-one rule

The one-for-one rule applies to the proposed CSR and the proposed amendments to the Cannabis Regulations. The details of the estimates, including assumptions, are available upon request from csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca.

1. Proposed Controlled Substances Regulations

The proposed CSR would result in a net reduction in regulatory titles and in a net decrease in the administrative burden on affected businesses. The one-for-one rule applies and the proposed CSR would be considered an “OUT” under the rule.

Reduction in regulatory titles

The proposed CSR would repeal four existing regulatory titles (i.e. NCR, BOTSR, NCPR and the Exemption Regulations) and would replace them with one new regulatory title; as a result, a net of three titles out is counted under the rule.

Administrative costs to impacted businesses

As explained in the cost-benefit analysis above, affected businesses would assume the following administrative costs:

• Reviewing the regulatory provisions related to administrative requirements by existing businesses;
• Recording of information by licensed dealers and pharmacists; and
• Obtaining approval of changes to the record-keeping method by licensed dealers.

Administrative cost savings to impacted businesses

Affected businesses would also see the following administrative cost savings:

• Time saved reviewing one set of regulations instead of multiple regulations and exemptions by regulated parties entering the market after publication of the proposed CSR in the Canada Gazette, Part II;
• Reduced reporting requirements for licensed dealers regarding losses and thefts;
• Pharmacists no longer needing a licence in order to provide central fill services for controlled substances, or to notify about a pharmacy closure; and
• Holders of test kit registration numbers only needing to notify the Minister of changes made to a test kit containing a controlled substance instead of requiring new registration numbers.

As per the requirements of the Red Tape Reduction Act and the Red Tape Reduction Regulations (RTRR), the administrative impacts on all affected businesses are estimated in dollars of the year 2012 using the prescribed formula in the RTRR over 10 periods of 12 months (2025–2034) starting from the publication in the Canada Gazette, Part II, and discounted to 2012 using a 7% real discount rate.

The proposed CSR would result in an increase of $449,543 in administrative costs and a decrease of $516,869. Overall, there would be a net reduction in administrative burden costs to businesses, estimated to be a saving of $67,326 (PV) or $9,586 annually.

Net reduction in administrative burden

• Number of years: 10 periods of 12 months (2025–2026 to 2034–2035) starting from publication
• Base year for costing: 2012
• Present value base year: 2012
• Discount rate: 7%

Table 8: Net reduction in administrative costs

Net impacts	Present value	Annualized value
Total increase in administrative costs	$449,543	$64,005
Total decrease in administrative costs	$516,869	$73,591
Net reduction in administrative costs	$67,326	$9,586

2. Proposed Regulations Amending the Cannabis Regulations (Harmonization with Certain Provisions of the Controlled Substances Regulations)

The one-for-one rule applies since there is an incremental increase in the administrative burden on business and the proposed amendments to the Cannabis Regulations are considered an “IN” under the rule. No regulatory titles are repealed or introduced.

The proposed amendments to the Cannabis Regulations would result in an incremental increase in the administrative burden on businesses associated with time that would be spent to review the provisions related to administrative requirements as well as time that would be spent on recording information (e.g. recording the DIN, brand name and quantity of the prescription drug containing cannabis). More information can be found in the cost-benefit analysis above.

The proposed amendments to the Cannabis Regulations would result in an additional cost of $67,685 (PV) or an annualized $9,637 in administrative costs as estimated using the Red Tape Reduction Regulations’ prescribed method.

3. Proposed Regulations Amending Certain Regulations Concerning Controlled Substances

The one-for-one rule does not apply as there is no impact on business.

Regulatory cooperation and alignment

The CDSA, Cannabis Act, and regulations made under those Acts are the means by which Canada, as a signatory, fulfills its international obligations under the United Nations drug control conventions. Since the main focus of this regulatory proposal is to consolidate and modernize existing regulatory requirements, it is not necessary to pursue regulatory alignment or regulatory cooperation with another jurisdiction. Alignment that currently exists between the current regulations and those of any other jurisdiction would be maintained.

Strategic environmental assessment

The regulatory proposal would consolidate and modernize the current regulatory requirements for controlled substances and would improve the alignment between these requirements and those of the Cannabis Regulations to the extent necessary. The regulatory proposal would not have any negative or positive effects on the environment. In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

A sex- and gender-based analysis plus assessment was conducted as part of the regulatory development for the proposed CSR and the proposed amendments to the Cannabis Regulations to determine

• whether individual people in Canada would be affected; and
• whether the regulatory changes would affect a particular group or subgroup of people in Canada differently than others when compared to the status quo.

The proposed CSR would amalgamate several sets of regulations. While some changes to regulatory provisions are being proposed, most of the proposed provisions would not affect individual people in Canada. However, there would be additional benefits to travelling individuals, compared to the benefit the current exemption provides, as they would be able to carry greater quantities (up to a 90-day supply) of prescription medications containing cannabis, a narcotic or a controlled drug. Therefore, travellers needing to carry a quantity of prescription drugs containing cannabis or a controlled substance for more than 30 days, but up to a 90-day supply, would no longer need to apply for an individual exemption under the CDSA or the Cannabis Act. This benefit would be imparted to all categories of travellers — particularly those with chronic medical conditions requiring ongoing treatment beyond 30 days — and would apply equally to all individuals who are travelling into or out of Canada who require prescription medications containing cannabis or a controlled substance to treat their medical conditions. No subgroups of travellers would be disproportionally impacted.

There are several exemptions already in place that pertain to individuals and health care professionals that would be incorporated into the proposed CSR. The benefits that these groups currently receive from these exemptions would continue to apply under the proposed CSR. Given that these exemptions would have continued to exist in the absence of regulations, formalizing them into the proposed CSR would not lead to any changes to the benefits the exemptions provide. Therefore, no individual people in Canada or subgroups of people in Canada are expected to be affected by formalizing these exemptions in the proposed CSR and no impacts based on sex- and gender-based analysis plus factors are anticipated.

Given that the proposed CSR and proposed amendments to the Cannabis Regulations would bring additional benefits to travellers and would maintain the benefits that certain class exemptions already provide to certain categories of health professionals, no concerns are anticipated from any stakeholders or the public.

Implementation, compliance and enforcement, and service standards

Implementation

It is proposed that the CSR would come into force 365 days after the day they are published in the Canada Gazette, Part II. This delayed coming-into-force date would provide regulated parties with sufficient time to prepare for the implementation of the proposed CSR and, where necessary, make adjustments to comply with the regulatory requirements around information and record-keeping. Consultations conducted with provincial regulatory bodies to date suggest that this delayed coming-into-force date is appropriate. For consistency, a similar coming-into-force date is suggested for the proposed consequential and coordinating amendments.

While Health Canada would continue to employ the existing mechanisms to administer the proposed CSR when they come into force, certain administrative adjustments would be made for implementation, including updating application forms (e.g. application for a dealer’s licence form), updating web pages as well as certain related existing exemptions, updating internal information management systems and repealing relevant class exemptions.

The proposed CSR and the proposed amendments to the Cannabis Regulations would not alter the existing administration and compliance mechanisms for these regulatory frameworks. Health Canada would prepare communications materials to inform stakeholders about the consolidated and modernized requirements in preparation for the final publication of the regulatory proposal. Health Canada would also reply to stakeholders’ enquiries as needed.

Compliance and enforcement

Compliance promotion and outreach activities (including publication of notices and guidance documents aimed at informing and educating stakeholders about the proposed CSR) would be developed in order to increase awareness of the modernized regulatory requirements and would assist regulated parties in further achieving compliance. Limited compliance promotion activities would also be undertaken with respect to the proposed amendments to the Cannabis Regulations.

Health Canada is responsible for authorizing (through licences, permits, and exemptions) legitimate activities with controlled substances or cannabis as per the CDSA or Cannabis Act and their regulations and for monitoring compliance with regulatory requirements. The Canada Border Services Agency supports compliance monitoring for controlled substances and cannabis at the border. Federal, provincial and local law enforcement are responsible for taking enforcement action in response to contraventions of the CDSA or the Cannabis Act and their regulations.

In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, effectiveness in achieving compliance with the CDSA or the Cannabis Act and their regulations, and consistency in enforcement when deciding which enforcement measures to take. Under the CDSA and the Cannabis Act, a range of penalties apply to the offences associated with activities involving the use of controlled substances or cannabis. These could include warning letters, corrective action plans, seizures, and recommendations for prosecutions. The maximum penalty for indictable offences with respect to controlled substances is imprisonment for a term not exceeding 10 years and with respect to cannabis is imprisonment for a term not exceeding 14 years.

As the proposed CSR represents a consolidation and modernization of current regulations for controlled substances, there would be no change in the manner in which regulations are enforced under the CDSA.

Service standards

Although the proposed CSR would improve the administration of and compliance with these regulations, no changes in service standards are anticipated. The current service standards that already exist for issuing licences, permits and exemptions would remain in place and no additional service standards would be required.

Contact

Jennifer Pelley
Director
Office of Legislative and Regulatory Affairs
Controlled Substances and Overdose Response Directorate
Controlled Substances and Cannabis Branch
Health Canada
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Controlled Substances Regulations under subsection 55(1)^{footnote a} of the Controlled Drugs and Substances Act ^{footnote b}.

Interested persons may make representations concerning the proposed regulations within 60 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Office of Legislative and Regulatory Affairs, Controlled Substances Directorate, Controlled Substances and Cannabis Branch, Department of Health, Address Locator: 0302A, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9 (email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca).

Ottawa, May 23, 2024

Wendy Nixon
Assistant Clerk of the Privy Council

TABLE OF PROVISIONS

Controlled Substances Regulations

Interpretation

1 Definitions

General

2 Non-application — member of police force

3 Controlled drug — Part 3 of Schedule 2

4 Authorizations — agents and mandataries

Possession

Controlled Drugs, Narcotics and Targeted Substances

5 Authorized persons

Restricted Drugs

6 Authorized persons

Licensed Dealers

Dealer’s Licences

Requirement to Obtain

7 Activities

Preliminary Requirements

8 Senior person in charge

9 Qualified person in charge

10 Ineligibility

Issuance of Licence

11 Application

12 Issuance

13 Validity

14 Refusal

Renewal of Licence

15 Application

16 Renewal

17 Validity

18 Refusal

Amendment of Licence

19 Application

20 Amendment

21 Validity

22 Refusal

Changes Requiring Prior Approval by Minister

23 Application

24 Approval

25 Refusal

Changes Requiring Notice to Minister

26 Prior notice

27 Notice — five days

28 Notice — 10 days

29 Notice of cessation of activities

Changes to Terms and Conditions of Licence

30 Addition or modification

31 Deletion of term or condition

Suspension and Revocation of Licence

32 Suspension

33 Revocation

Import Permits

34 Application

35 Issuance

36 Validity

37 Refusal

38 Providing copy of permit

39 Declaration

40 Suspension

41 Revocation

Export Permits

42 Application

43 Issuance

44 Validity

45 Refusal

46 Providing copy of permit

47 Declaration

48 Suspension

49 Revocation

Authorizations and General Conditions Applicable to Activities

50 Authorized activities

51 Packaging — conditions

52 Destruction

53 Qualified person in charge present

54 Identification

55 Information and documents

Sale of Controlled Substances

56 Sale to another licensed dealer

57 Sale to a pharmacist

58 Sale to a practitioner

59 Sale to a hospital

60 Sale to an exempted person

61 Sale to Minister

62 Anticipated multiple sales

Verification of Identity

63 Orders

Delivery, Sending and Transportation

64 Requirements during transport

Security

65 Protective measures

66 Loss or theft — licences and permits

67 Loss or theft — agent or mandatary

68 Suspicious transaction

69 Partial protection against self-incrimination

Destruction of Controlled Substances

70 Destruction at site

71 Destruction elsewhere than at site

72 Application for approval

73 Approval

Documents

Information

74 Substances ordered and received

75 Substances sold

76 Substances produced or packaged

77 Substances in stock

78 Written orders

79 Transportation

80 Substances imported

81 Substances exported

82 Explainable loss of controlled substance

83 Destruction

84 Monthly report

Recording Information and Retention and Provision of Documents

85 Method of recording

86 Documents to retain

87 Place

88 Quality of documents

89 Providing documents

Pharmacists

Non-application

90 Pharmacists practising in a hospital

Sale of Controlled Substances

91 Sale to a licensed dealer

92 Sale to another pharmacist

93 Sale to a practitioner

94 Sale to a hospital

95 Sale to an exempted person

96 Sale to Minister

97 Sale to an individual

Compounding of Finished Products

98 Orders and prescriptions

Prescriptions

99 Extension of prescription

100 Transfer of prescription

Verification of Identity

101 Orders and prescriptions

Packaging and Labelling

102 Receipt of substance from an individual

Storage

103 Authorized access

Delivery, Sending and Transportation

104 Authorization

105 Requirements during transportation

Security

106 Protective measures

107 Loss or theft — agent or mandatary

Destruction of Controlled Substances

108 Conditions

Documents

Information

109 Substances ordered and received

110 Substances sold — individuals

111 Finished products compounded

112 Written orders and prescriptions

113 Verbal orders and prescriptions

114 Prescriptions refilled and extended

115 Prescription transfers — transferring pharmacist

116 Transportation

117 Destruction

Recording Information and Retention and Provision of Documents

118 Method of recording

119 Documents to retain

120 Place

121 Quality of documents

122 Providing documents

Practitioners

Prescriptions

123 Prescriptions

Sale of Controlled Substances

124 Sale to a licensed dealer

125 Sale to Minister

126 Sale to an individual

Administration of Controlled Substances

127 General conditions

128 Emergency supply

Storage

129 Authorized access

Delivery, Sending and Transport

130 Authorization

131 Requirements during transportation

Security

132 Protective measures

133 Loss or theft — agent or mandatary

Destruction of Controlled Substances

134 Conditions

Documents

Application

135 Scope

Information

136 Substances received

137 Substances sold — persons other than individuals

138 Substances prescribed, administered or sold — individuals

139 Emergency supply

140 Written orders

141 Transportation

142 Destruction

Recording Information and Retention and Provision of Documents

143 Method of recording

144 Documents to retain

145 Place

146 Quality of documents

147 Providing documents

Prescribed Practitioners

148 Additional conditions

149 Midwife and podiatrist

Hospitals

Application and General Conditions for Activities

150 Application

151 Non-application — restricted drugs

152 Person in charge

153 Orders placed on behalf of hospital

Sale of Controlled Substances

154 Sale to a licensed dealer

155 Sale to a pharmacist

156 Sale to a practitioner

157 Sale to another hospital

158 Sale to Minister

159 Sale to an individual

Administration to Individual

160 Conditions

Compounding of Finished Products

161 Orders and prescriptions

Verification of Identity

162 Orders

Storage

163 Authorized access

Delivery, Sending and Transport

164 Authorization

165 Requirements during transportation

Security

166 Protective measures

167 Loss or theft — agent or mandatary

Destruction of Controlled Substances

168 Conditions

Documents

Information

169 Substances received

170 Substances sold — persons other than individuals

171 Substances sold or administered — individuals

172 Finished products compounded

173 Written orders

174 Verbal orders

175 Transportation

176 Destruction

Recording Information and Retention and Provision of Documents

177 Method of recording

178 Documents to retain

179 Place

180 Quality of documents

181 Providing documents

Minister

182 Communication of information to licensing authority

183 Provision of information to customs officer

184 Communication of information to International Narcotics Control Board

185 Provision of information to competent authorities

186 Restricted drugs — temporary accelerated scheduling

Individuals

187 Transport and provision

188 Return to a pharmacist for destruction

189 Importation

190 Export

Test Kits

191 Application

192 Requirement to obtain a registration number

193 Application for registration number

194 Issuance of registration number

195 Refusal to issue registration number

196 Notice to Minister

197 Cancellation of registration number

198 Authorized activities

Miscellaneous Provisions

Advertising

199 Restrictions

Notification of Application for Order of Restoration

200 Written notification

201 Repeals

Coming into Force

206 Publication

• SCHEDULE 1
• SCHEDULE 2
  • PART 1
  • PART 2
  • PART 3
• SCHEDULE 3
  • PART 1
  • PART 2
• SCHEDULE 4
  • PART 1
  • PART 2
  • PART 3

Controlled Substances Regulations

Interpretation

Definitions

1 (1) The following definitions apply in these Regulations.

Act

means the Controlled Drugs and Substances Act. (Loi)

adult

means an individual who is 18 years of age or older. (adulte)

advertisement

includes any representation by any means for the purpose of promoting, directly or indirectly, the sale or other disposal of a controlled substance. (publicité)

cannabis offence

means

• (a) an offence under subsection 9(1) or (2), 10(1) or (2), 11(1) or (2), 12(1), (4), (5), (6) or (7), 13(1) or 14(1) of the Cannabis Act; or
• (b) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction relative au cannabis)

CAS registry number

means the identification number assigned to a chemical by the Chemical Abstracts Service, a division of the American Chemical Society. (numéro d’enregistrement CAS)

competent authority

means a public authority of a foreign country that is authorized under the laws of that country to approve the importation or exportation of controlled substances into or from that country. (autorité compétente)

container

means an immediate container of a controlled substance, unless otherwise specified, but does not include a collection container. (contenant)

controlled drug

means a substance set out in Schedule 2. (drogue contrôlée)

destroy

, in relation to a controlled substance, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction)

drug identification number

means the identification number assigned to a drug under paragraph C.01.014.2(1)(a) of the Food and Drug Regulations. (identification numérique)

emergency medical service vehicle

means any conveyance authorized under the laws of a province to transport individuals to hospitals and on which emergency medical services are provided. (véhicule de service médical d’urgence)

emergency supply

means controlled substances that are stored in a place that is either in a remote area where emergency medical treatment is not readily available or in an emergency medical service vehicle. (approvisionnement d’urgence)

finished product

means a finished product that contains a controlled substance set out in any of Schedules 1 to 4, that is in a form that is intended to be administered to an individual or animal and, in the case of a finished product that does not contain a restricted drug, that

• (a) has a drug identification number; or
• (b) is compounded by a pharmacist or pharmacy technician in accordance with these Regulations. (produit fini)

health professional

means a person who is entitled under the laws of a province to practise a profession in a field related to health and who is practising in that province. (professionnel de la santé)

hospital

means a facility

• (a) that is licensed, approved or designated by a province under the laws of the province to provide health care or treatment to individuals or animals; or
• (b) that is owned or operated by the government of Canada or of a province and that provides health services. (hôpital)

international obligation

means an obligation relative to a controlled substance set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)

letter of authorization

means the letter of authorization issued under section C.08.010 of the Food and Drug Regulations. (lettre d’autorisation)

licensed dealer

means the holder of a licence issued under subsection 12(1). (distributeur autorisé)

midwife

means a person who is entitled under the laws of a province to practise midwifery and who is practising midwifery in that province. (sage-femme)

mixture

means a mixture that contains a controlled substance set out in any of Schedules 1 to 4, but does not include a finished product. (mélange)

narcotic

means a substance set out in Schedule 1. (stupéfiant)

nurse practitioner

means a person who is entitled under the laws of a province to practise as a nurse practitioner or to practise under an equivalent designation and who is practising as such in that province. For the purpose of this definition, a designation is equivalent when it designates a person who

• (a) is a registered nurse;
• (b) possesses additional training and experience related to health care; and
• (c) can autonomously make diagnoses, request diagnostic tests and interpret their results, prescribe drugs and perform other specific procedures under the laws of a province. (infirmier praticien)

peace officer

has the same meaning as in section 2 of the Criminal Code. (agent de la paix)

person in charge of a hospital

means a person who has overall responsibility for managing a hospital’s activities with respect to controlled substances. (responsable d’un hôpital)

pharmacist

means a person who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)

pharmacy intern

means a person who is enrolled as a pharmacy student at a provincially recognized school, or who is entitled under the laws of a province to work as a pharmacy intern or to work under an equivalent designation, and who is working as such in a pharmacy in that province under the supervision of a pharmacist. (stagiaire en pharmacie)

pharmacy technician

means a person who is entitled under the laws of a province to practise as a pharmacy technician or to practise under a designation that the Minister considers equivalent and who is practising as such in that province. (technicien en pharmacie)

podiatrist

means a person who is entitled under the laws of a province to practise podiatry or chiropody and who is practising podiatry or chiropody in that province. (podiatre)

prescription

means an authorization given by a practitioner that a stated amount of a controlled substance, other than a restricted drug, be sold or provided for the individual named or the animal identified in it. (prescription)

qualified person in charge

means the individual designated under subsection 9(1). (responsable qualifié)

restricted drug

means a substance that is set out in Schedule 4. (drogue d’utilisation restreinte)

Security Directive

means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité)

send

does not include sending by mail. (expédition)

senior person in charge

means the individual designated under section 8. (responsable principal)

specialized in destruction

, in relation to a licensed dealer, describes a dealer whose licence specifies that they only deal in the destruction of controlled substances. (spécialisé en destruction)

targeted substance

means a substance set out in Schedule 3. (substance ciblée)

test kit

means a kit

• (a) that contains a controlled substance and an adulterating or denaturing agent;
• (b) that is used to test for a controlled substance; and
• (c) the contents of which are not intended or likely to be consumed by, or administered to, an individual or animal. (trousse d’essai)

Interpretation — controlled substances

(2) For the application of these Regulations, a controlled substance refers to any of the following substances:

• (a) a narcotic;
• (b) a controlled drug;
• (c) a targeted substance;
• (d) a restricted drug.

Interpretation — practitioners

(3) For the purpose of the definition practitioner in subsection 2(1) of the Act, the following persons are prescribed:

• (a) midwives;
• (b) nurse practitioners; and
• (c) podiatrists.

General

Non-application — member of police force

2 The following persons are exempt from the application of these Regulations if, in respect of their activity, they are exempt from the application of sections 5 to 7.1 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations:

• (a) a member of a police force, as defined in section 1 of those regulations; or
• (b) a person acting under the direction and control of that member.

Controlled drug — Part 3 of Schedule 2

3 The Act and these Regulations do not apply in respect of a finished product that contains a controlled drug set out in Part 3 of Schedule 2 and that is

• (a) in a form that allows the sustained release of an active ingredient over a certain period of time; and
• (b) intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency.

Authorizations — agents and mandataries

4 An agent or mandatary of a person, including an employee of that person or another person who is acting under a contract with that person, may conduct an activity if the following conditions are met:

• (a) in the case of the person,
  • (i) they are authorized under these Regulations to conduct the activity, and
  • (ii) if applicable, the provincial professional licensing authority of the province in which they are practising does not prohibit the delegation of the activity to the agent or mandatary; and
• (b) in the case of the agent or mandatary,
  • (i) if applicable, they are authorized by the provincial professional licensing authority of the province in which they are practising to conduct the activity,
  • (ii) they do so as part of their role as agent or mandatary or their employment duties and functions or in the performance of their contract, and
  • (iii) they comply with the requirements that apply to the person referred to in paragraph (a).

Possession

Controlled Drugs, Narcotics and Targeted Substances

Authorized persons

5 (1) A person referred to in subsection (2) is authorized to possess one of the following controlled substances if they have obtained the substance in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation or from a person who is exempt under subsection 56(1) of the Act from the application of subsection 5(1) of the Act with respect to that controlled substance:

• (a) a narcotic set out in Schedule 1;
• (b) a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 and 17 of Part 1 of Schedule 2; and
• (c) a targeted substance set out in Part 2 of Schedule 3.

Conditions

(2) The authorized persons are

• (a) a person who conducts an activity, with respect to the controlled substance, that is necessary for their business or the practise of their profession and who is
  • (i) a licensed dealer,
  • (ii) a pharmacist or pharmacy technician, other than one who is practising in a hospital, or
  • (iii) a practitioner who is registered and entitled to practise in
    • (A) the province in which they possess the controlled substance, or
    • (B) a province other than the province in which they possess the controlled substance, if they possess the substance for emergency medical purposes only;
• (b) a hospital;
• (c) an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada who possesses the controlled substance in connection with their employment;
• (d) the Minister; or
• (e) an individual who
  • (i) has obtained the controlled substance in accordance with a prescription that was issued or obtained in accordance with these Regulations from one of the following persons for their own use, for the use of another individual or for an animal:
    • (A) a practitioner, or
    • (B) a pharmacist, or
  • (ii) has imported the controlled substance
    • (A) for their own use,
    • (B) for the use and on the behalf of an accompanying individual, or
    • (C) for an animal for which the individual is responsible and that is accompanying the individual.

Agent or mandatary — person in paragraph (2)(c)

(3) An agent or mandatary of a person referred to in paragraph (2)(c) may only have a controlled substance set out in subsection (1) in their possession if

• (a) they have reasonable grounds to believe that person is a person referred to in paragraph (2)(c); and
• (b) they possess the controlled substance for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

Export

(4) A licensed dealer or an individual referred to in section 190 may possess a controlled substance, other than a restricted drug, for the purpose of exporting it if the substance was obtained in accordance with these Regulations.

Restricted Drugs

Authorized persons

6 (1) The following persons are authorized to possess a restricted drug listed in Part 1 of Schedule 4 if they have obtained the drug in accordance with these Regulations or in the course of activities conducted in connection with the administration or enforcement of an Act or regulation:

• (a) a licensed dealer;
• (b) a pharmacist, other than one who is practising in a hospital;
• (c) a practitioner who is named in a letter of authorization;
• (d) an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada who possesses the restricted drug in connection with their employment;
• (e) the Minister; and
• (f) an individual who has obtained the restricted drug from a practitioner named in a letter of authorization for their own use.

Agent or mandatary — person in paragraph (1)(d)

(2) An agent or mandatary of a person referred to in paragraph (1)(d) may only have a restricted drug listed in Part 1 of Schedule 4 in their possession if

• (a) they have reasonable grounds to believe that person is a person referred to in paragraph (1)(d); and
• (b) they possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

Export

(3) A licensed dealer may possess a restricted drug for the purpose of exporting it if the drug was obtained in accordance with these Regulations.

Licensed Dealers

Dealer’s Licences

Requirement to Obtain

Activities

7 (1) Persons referred to in subsection (2) are required to obtain a dealer’s licence for each site at which they intend to conduct one of the following activities:

• (a) producing a controlled substance, unless the person doing so is a pharmacist or pharmacy technician who is compounding a finished product in accordance with these Regulations;
• (b) packaging, selling, providing, delivering, sending or transporting a controlled substance, unless the person doing so is:
  • (i) a pharmacist or pharmacy technician who is not practising in a hospital,
  • (ii) a practitioner,
  • (iii) a hospital, or
  • (iv) an individual referred to in section 187 or 188;
• (c) importing or exporting a controlled substance, unless the person doing so is an individual referred to in section 189 or 190; and
• (d) only destroying a controlled substance.

Eligible persons

(2) The persons who are eligible to obtain a dealer’s licence are

• (a) an individual who ordinarily resides in Canada;
• (b) an organization that has its head office in Canada or operates a branch office in Canada; or
• (c) the holder of a position that includes responsibility for controlled substances on behalf of the government of Canada or of a province, a police force, a hospital or a university in Canada.

Preliminary Requirements

Senior person in charge

8 (1) An applicant for a dealer’s licence must designate only one individual, who may be the applicant if the applicant is an individual, as the senior person in charge who has overall responsibility for management of the activities with respect to controlled substances that are specified in the licence application.

Qualifications

(2) Only a person who has sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence application to properly carry out their duties may be designated as a senior person in charge.

Qualified person in charge

9 (1) An applicant for a dealer’s licence must designate only one individual, who may be the applicant if the applicant is an individual, as the qualified person in charge who is responsible for supervising the activities with respect to controlled substances that are specified in the licence application and for ensuring that those activities comply with these Regulations.

Alternate qualified person in charge

(2) An applicant for a dealer’s licence may designate an individual, who may be the applicant if the applicant is an individual, as an alternate qualified person in charge who is authorized to replace the qualified person in charge when that person is absent.

Qualifications

(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:

• (a) they work at the site specified in the dealer’s licence application;
• (b) they
  • (i) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
  • (ii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (i) and hold one of the following assessments that establishes the equivalency of the diploma, certificate or credential to one of the documents referred to in that subparagraph:
    • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
    • (B) an equivalency assessment issued by an institution or organization that is responsible for issuing equivalency assessments and is recognized by a province;
• (c) they have sufficient knowledge of and experience with the use and handling of the controlled substances specified in the dealer’s licence application to properly carry out their duties; and
• (d) they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence application to properly carry out their duties.

Exception

(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements set out in paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if

• (a) no other individual working at the site meets those requirements;
• (b) those requirements are not necessary for the activities specified in the licence application; and
• (c) the individual has sufficient knowledge acquired from a combination of education, training or work experience to properly carry out their duties.

Ineligibility

10 (1) An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,

• (a) in respect of a designated substance offence, a cannabis offence or any other offence referred to in subsection (2), the individual
  • (i) was convicted as an adult, or
  • (ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or
• (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence, a cannabis offence or any other offence referred to in subsection (2),
  • (i) the individual was convicted as an adult, or
  • (ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence.

Other offences

(2) For the purpose of subsection (1), the other offences are

• (a) an offence involving the financing of terrorism referred to in any of sections 83.02 to 83.04 of the Criminal Code;
• (b) an offence involving fraud referred to in any of sections 380 to 382 of the Criminal Code;
• (c) the offence of laundering proceeds of crime referred to in section 462.31 of the Criminal Code;
• (d) an offence involving a criminal organization referred to in any of sections 467.11 to 467.13 of the Criminal Code; and
• (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d).

Issuance of Licence

Application

11 (1) An application to obtain a dealer’s licence must be submitted to the Minister and must contain

• (a) if the licence is requested by
  • (i) an individual, the individual’s name,
  • (ii) an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and
  • (iii) the holder of a position described in paragraph 7(2)(c), the applicant’s name and the title of the position;
• (b) the municipal address, telephone number and, if applicable, the email address of the site specified in the licence application and, if different from the municipal address, its mailing address;
• (c) the name, date of birth, telephone number and email address of the proposed senior person in charge;
• (d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge,
  • (i) their name, date of birth, telephone number and email address,
  • (ii) the title of their position at the site,
  • (iii) the name and title of the position of their immediate supervisor at the site,
  • (iv) if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and
  • (v) their education, training and work experience that are relevant to their duties;
• (e) the activities that are to be conducted and the controlled substances in respect of which each of the activities is to be conducted;
• (f) if the licence is requested in order to produce or package a controlled substance set out in any of Schedules 1 to 4, for each substance,
  • (i) its name, its CAS registry number, if any, as well as its form, the quantity that the applicant expects to produce or package under the licence and the period during which that quantity would be produced or packaged, and
  • (ii) if it is to be produced or packaged for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer;
• (g) if the licence is requested to produce or package a mixture or finished product, for each mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container,
  • (iii) its drug identification number, if any,
  • (iv) if it is to be produced or packaged by or for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer, and
  • (v) if the applicant’s name appears on any label, as defined in section 2 of the Food and Drugs Act, of the finished product, a copy of that label;
• (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the controlled substance for which the activity is to be conducted and the purpose of the activity;
• (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and
• (j) a detailed description of the method of recording information that the applicant proposes to use for the purpose of section 85.

Documents

(2) The application must be accompanied by the following documents:

• (a) if the applicant is an organization, a copy of
  • (i) the certificate of incorporation or other constituting instrument,
  • (ii) any document filed with the province in which its site is located that states the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and
  • (iii) the permit or licence that is issued by the municipality in which its site is located that authorizes the business to operate, if applicable;
• (b) individual declarations, signed and dated by each of the proposed senior person in charge, the qualified person in charge and any proposed alternate qualified person in charge, attesting that the signatory is not ineligible for a reason specified in section 10;
• (c) a document issued by a Canadian police force or a company that is accredited by the Royal Canadian Mounted Police in relation to each person referred to in paragraph (b) indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 10(1)(a)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii);
• (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 10(1)(b)(i) or received a sentence as specified in subparagraph 10(1)(b)(ii);
• (e) a declaration, signed and dated by the proposed senior person in charge, attesting that they have the knowledge required under subsection 8(2) and that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 9(3)(c) and (d);
• (f) with respect to the proposed qualified person in charge or any proposed alternate qualified person in charge, a copy of their diploma, certificate or credential referred to in paragraph 9(3)(b) and, if applicable, the equivalency assessment referred to in subparagraph 9(3)(b)(ii); and
• (g) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement set out in paragraph 9(3)(b), a detailed description of the education, training and work experience that is required under paragraph 9(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.

Signature and attestation

(3) The application must

• (a) be signed and dated by the proposed senior person in charge; and
• (b) include an attestation by that person that
  • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
  • (ii) they have the authority to bind the applicant.

Additional information and documents

(4) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Issuance

12 (1) Subject to section 14, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains

• (a) the licence number;
• (b) if the licensed dealer is an individual, their name and, if applicable, title, or if the licensed dealer is an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence;
• (c) the specified activities and, for each activity, the name of the controlled substance that is set out in any of Schedules 1 to 4 or that is contained in a mixture or finished product;
• (d) the municipal address of the site at which the activity is to be conducted;
• (e) the security level at the site, determined in accordance with the Security Directive;
• (f) the effective date of the licence;
• (g) the expiry date of the licence, which must not be later than three years after its effective date;
• (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to
  • (i) ensure that an international obligation is respected,
  • (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or
  • (iii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use; and
• (i) if the licensed dealer produces or packages a controlled substance that is set out in any of Schedules 1 to 4, the quantity that they may produce or package and the production or packaging period.

Licence integrity

(2) A person must not alter or deface in any manner a dealer’s licence.

Validity

13 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.

Refusal

14 (1) The Minister must refuse to issue a dealer’s licence if

• (a) the applicant does not meet the requirement set out in subsection 7(2);
• (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened
  • (i) a provision of the Act, the Cannabis Act or their regulations, or
  • (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;
• (c) during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
• (d) an activity for which the licence is requested would contravene an international obligation;
• (e) in the case of a narcotic, an activity for which the licence is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;
• (f) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;
• (g) the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 85;
• (h) the applicant has not provided the Minister with the information or documents required under subsection 11(4) or by the date specified in the written request referred to in that subsection, or the information or documents that they have provided by that date are not sufficient to complete the review of the licence application;
• (i) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;
• (j) information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravenes an international obligation; or
• (k) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Exceptions

(2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (i) if the applicant meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

• (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and
• (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

Notice

(3) Before refusing to issue a licence, the Minister must provide the applicant with a written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

Renewal of Licence

Application

15 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections 11(1) and (2).

Signature and attestation

(2) The application must

• (a) be signed and dated by the senior person in charge of the site specified in the application; and
• (b) include an attestation by that person that
  • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
  • (ii) they have the authority to bind the licensed dealer.

Additional information and documents

(3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Renewal

16 (1) Subject to section 18, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in subsection 12(1).

Terms and conditions

(2) When renewing a dealer’s licence, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

• (a) ensure that an international obligation is respected;
• (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or
• (c) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Validity

17 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.

Refusal

18 (1) The Minister must refuse to renew a dealer’s licence if

• (a) the licensed dealer no longer meets the requirement set out in subsection 7(2);
• (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened
  • (i) a provision of the Act, the Cannabis Act or their regulations, or
  • (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;
• (c) during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
• (d) an activity for which the renewal is requested would contravene an international obligation;
• (e) in the case of a narcotic, an activity for which the renewal is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;
• (f) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;
• (g) the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 85;
• (h) the licensed dealer has not provided the Minister with the information or documents required under subsection 15(3) or by the date specified in the written request referred to in that subsection, or the information or documents that they have provided by that date are not sufficient to complete the review of the renewal application;
• (i) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the renewal application;
• (j) information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravened an international obligation; or
• (k) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Exceptions

(2) The Minister must not refuse to renew a licence under paragraph (1)(b) or (i) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

• (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

Notice

(3) Before refusing to renew a licence, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Amendment of Licence

Application

19 (1) Before making a change affecting any information that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in subsections 11(1) and (2) that are relevant to the proposed amendment.

Signature and attestation

(2) The application must

• (a) be signed and dated by the senior person in charge of the site specified in the application; and
• (b) include an attestation by that person that
  • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
  • (ii) they have the authority to bind the licensed dealer.

Additional information and documents

(3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Amendment

20 (1) Subject to section 22, on completion of the review of the amendment application, the Minister must amend the dealer’s licence.

Terms and conditions

(2) When amending a dealer’s licence, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

• (a) ensure that an international obligation is respected;
• (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the amendment; or
• (c) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Validity

21 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.

Refusal

22 (1) The Minister must refuse to amend a dealer’s licence if

• (a) the licensed dealer no longer meets the requirement set out in subsection 7(2);
• (b) during the 10 years before the day on which the amendment application is submitted, the senior person in charge or qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
• (c) an activity for which the amendment is requested would contravene an international obligation;
• (d) in the case of a narcotic, an activity for which the amendment is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;
• (e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the amendment is requested;
• (f) the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 85;
• (g) the licensed dealer has not provided the Minister with the information or documents required under subsection 19(3) or by the date specified in the written request referred to in that subsection, or the information or documents that they have provided by that date are not sufficient to complete the review of the amendment application;
• (h) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the amendment application; or
• (i) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Exceptions

(2) The Minister must not refuse to amend a licence under paragraph (1)(h) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

• (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

Notice

(3) Before refusing to amend a licence, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Changes Requiring Prior Approval by Minister

Application

23 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:

• (a) a change affecting the security measures in place at the site specified in the dealer’s licence;
• (b) a change affecting the method of recording information referred to in paragraph 11(1)(j);
• (c) the replacement of the senior person in charge;
• (d) the replacement of the qualified person in charge; or
• (e) the replacement or addition of an alternate qualified person in charge.

Information and documents

(2) The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1):

• (a) in the case of a change affecting the security measures in place at the site specified in the dealer’s licence or the method of recording information referred to in paragraph 11(1)(j), details of the change;
• (b) in the case of a replacement of the senior person in charge,
  • (i) the information specified in paragraph 11(1)(c), and
  • (ii) the documents specified in paragraphs 11(2)(b) to (e); and
• (c) in the case of a replacement of the qualified person in charge or a replacement or addition of an alternate qualified person in charge,
  • (i) the information specified in paragraph 11(1)(d), and
  • (ii) the documents specified in paragraphs 11(2)(b) to (f).

Additional information and documents

(3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Approval

24 (1) Subject to section 25, on completion of the review of the application for approval of the change, the Minister must approve the change.

Terms and conditions

(2) When approving a change, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete one in order to

• (a) ensure that an international obligation is respected;
• (b) ensure conformity with the requirements associated with the security level specified in the licence; or
• (c) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Refusal

25 (1) The Minister must refuse to approve the change if

• (a) during the 10 years before the day on which the application for approval of the change is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
• (b) the licensed dealer has not provided the Minister with the information or documents required under subsection 23(3) or by the date specified in the written request referred to in that subsection, or the information or documents that they have provided by that date are not sufficient to complete the review of the application for approval of the change;
• (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the application for approval of the change; or
• (d) the Minister has reasonable grounds to believe that the change would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Exceptions

(2) The Minister must not refuse to approve a change under paragraph (1)(c) if the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.

Notice

(3) Before refusing to approve a change, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Changes Requiring Notice to Minister

Prior notice

26 (1) A licensed dealer must notify the Minister in writing before

• (a) producing or packaging a mixture or finished product that is not set out in the most recent update of the information and label referred to in paragraph 11(1)(g); or
• (b) making a change to a mixture or finished product that is set out in that most recent update, if the change affects any of the information or label that has previously been submitted.

Information and documents

(2) The notice must contain the information that is necessary to update the information or label referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label referred to in that paragraph or, if applicable, a copy of the updated label.

Notice — five days

27 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice — 10 days

28 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:

• (a) a person ceases to act as the senior person in charge; or
• (b) the licensed dealer ceases to produce or package a mixture or finished product that is set out in the most recent update of the information and label referred to in paragraph 11(1)(g).

Information and document

(2) A notice concerning a change referred to in paragraph (1)(b) must contain the information that is necessary to update the information referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label for any other substances.

Notice of cessation of activities

29 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Content of notice

(2) The notice must be signed and dated by the senior person in charge and contain the following information:

• (a) the expected date of the cessation of activities at the site;
• (b) a description of the manner in which any remaining controlled substances on the site as of that date will be disposed of by the licensed dealer, including
  • (i) if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, their name and, if applicable, title,
  • (ii) if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, their name and, if applicable, title, as well as the municipal address of their site, and
  • (iii) if some or all of them will be destroyed, the anticipated date of destruction and the municipal address of the place at which the destruction is to be carried out;
• (c) the municipal address of the place at which the licensed dealer’s documents will be kept after activities have ceased; and
• (d) the name, municipal address, telephone number and, if applicable, the email address of a person whom the Minister may contact for further information after activities have ceased.

Update

(3) After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge.

Changes to Terms and Conditions of Licence

Addition or modification

30 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add or modify a term or condition if the Minister has reasonable grounds to believe that it is necessary to do so to

• (a) ensure conformity with the Act, the Cannabis Act and their regulations;
• (b) ensure that an international obligation is respected;
• (c) ensure conformity with the requirements associated with the security level specified in the licence; or
• (d) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Notice

(2) Before adding a term or condition to a licence or modifying one, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Urgent circumstances

(3) Despite subsection (2), the Minister may add a term or condition to a licence or modify one without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.

Urgent circumstances — notice

(4) The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister provides the licensed dealer with a written notice that

• (a) sets out the reasons for the addition or modification;
• (b) gives the dealer an opportunity to be heard; and
• (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

Deletion of term or condition

31 (1) The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.

Notice

(2) The deletion takes effect as soon as the Minister provides the licensed dealer with a written notice to that effect.

Suspension and Revocation of Licence

Suspension

32 (1) The Minister must suspend a dealer’s licence in respect of any authorized activities in relation to any controlled substance without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.

Notice

(2) The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that

• (a) sets out the authorized activity and controlled substance that are the subject of the suspension, as well as the reasons for the suspension;
• (b) gives the dealer an opportunity to be heard; and
• (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

Reinstatement of licence

(3) The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Revocation

33 (1) Subject to subsection (2), the Minister must revoke a dealer’s licence if

• (a) the licensed dealer no longer meets the requirement set out in subsection 7(2);
• (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence;
• (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence;
• (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice;
• (e) the licensed dealer has contravened
  • (i) a provision of the Act, the Cannabis Act or their regulations, or
  • (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;
• (f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
• (g) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of an application relating to the licence; or
• (h) information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled substance to an illicit market or use.

Exceptions

(2) The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

• (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

Notice

(3) Before revoking a licence, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Import Permits

Application

34 (1) A licensed dealer must submit to the Minister, before each importation of a controlled substance, an application for an import permit that contains the following information:

• (a) their name and, if applicable, title, as well as their municipal address;
• (b) their dealer’s licence number and their business registration number assigned by the Minister of National Revenue;
• (c) the name and municipal address of the proposed customs broker for the licensed dealer, if any;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4,
  • (i) its name as set out in the dealer’s licence,
  • (ii) its CAS registry number, if any,
  • (iii) if it is a salt, the name of the salt,
  • (iv) its form,
  • (v) its purity and anhydrous content, and
  • (vi) its quantity;
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any;
• (f) the name and municipal address, in the country of export, of the exporter from whom the controlled substance is being obtained;
• (g) the name of the customs office where the importation is anticipated and the proposed date of importation;
• (h) each proposed mode of transportation and any proposed country of transit or transhipment; and
• (i) the name of the carrier that is proposed to transport the controlled substance to the customs office where the importation is anticipated.

Signature and attestation

(2) The application must

• (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and
• (b) include an attestation by that person that, to the best of their knowledge,
  • (i) the importation does not contravene the laws of the country of exportation or any country of transit or transhipment, and
  • (ii) all of the information and documents submitted in support of the application are correct and complete.

Additional information and documents

(3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Issuance

35 (1) Subject to section 37, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains

• (a) the permit number;
• (b) the information set out in subsection 34(1);
• (c) the effective date of the permit;
• (d) the expiry date of the permit, being the earlier of
  • (i) a date specified by the Minister that is not more than 180 days after its effective date, and
  • (ii) the expiry date of the dealer’s licence; and
• (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to
  • (i) ensure that an international obligation is respected, or
  • (ii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Permit integrity

(2) A person must not alter or deface in any manner an import permit.

Validity

36 An import permit is valid until the earliest of

• (a) the expiry date set out in the permit,
• (b) the date of the suspension or revocation of the permit under section 40 or 41,
• (c) the date of the suspension or revocation of the dealer’s licence under section 32 or 33, and
• (d) the date of the expiry, suspension or revocation of the export authorization that applies to the controlled substance to be imported and that is issued by the competent authority in the country of export.

Refusal

37 (1) The Minister must refuse to issue an import permit if

• (a) the licensed dealer is not authorized by their dealer’s licence to import the relevant controlled substance or their licence will expire before the date of importation;
• (b) the Minister has reasonable grounds to believe that the importation would contravene an international obligation;
• (c) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of the importation;
• (d) the licensed dealer has not provided the Minister with the information or documents required under subsection 34(3) or by the date specified in the written request referred to in that subsection, or the information or documents that they have provided by that date are not sufficient to complete the review of the permit application;
• (e) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application;
• (f) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or
• (g) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Notice

(2) Before refusing to issue the import permit, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Providing copy of permit

38 The holder of an import permit must provide a copy of the permit to the customs office at the time of importation.

Declaration

39 The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled substance specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:

• (a) their name and, if applicable, title;
• (b) their dealer’s licence number and the number of the import permit;
• (c) in the case of a controlled substance set out in any of Schedules 1 to 4,
  • (i) its name as set out in the dealer’s licence,
  • (ii) if it is a salt, the name of the salt,
  • (iii) its form, and
  • (iv) its quantity;
• (d) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any; and
• (e) the name of the customs office from which the controlled substance was released and the date of the release.

Suspension

40 (1) The Minister must suspend an import permit without prior notice if

• (a) the dealer’s licence is suspended;
• (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or
• (c) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment.

Notice

(2) The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that

• (a) sets out the reasons for the suspension;
• (b) gives the dealer an opportunity to be heard; and
• (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

Reinstatement of permit

(3) The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Revocation

41 (1) The Minister must revoke an import permit if

• (a) the dealer’s licence has been revoked;
• (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
• (c) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 40(2)(c) by the specified date; or
• (d) the Minister has reasonable grounds to believe that the licensed dealer submitted misleading information or falsified documents in or in support of the application for the permit.

Notice

(2) Before revoking an import permit, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Export Permits

Application

42 (1) A licensed dealer must submit to the Minister, before each exportation of a controlled substance, an application for an export permit that contains the following information and document:

• (a) their name and, if applicable, title, as well as their municipal address;
• (b) their dealer’s licence number and their business registration number assigned by the Minister of National Revenue;
• (c) the name and municipal address of the proposed customs broker for the licensed dealer, if any;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4,
  • (i) its name as set out in the dealer’s licence,
  • (ii) its CAS registry number, if any,
  • (iii) if it is a salt, the name of the salt,
  • (iv) its form,
  • (v) its purity and anhydrous content, and
  • (vi) its quantity;
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any;
• (f) the name and municipal address of the importer in the country of final destination;
• (g) the name of the customs office where the exportation is anticipated and the proposed date of exportation;
• (h) each proposed mode of transportation and any proposed country of transit or transhipment;
• (i) the name of the carrier that is proposed to transport the controlled substance to the customs office where the exportation is anticipated; and
• (j) a copy of the import authorization issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Signature and attestation

(2) The application must

• (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and
• (b) include an attestation by that person that, to the best of their knowledge,
  • (i) the exportation does not contravene the laws of the country of final destination or any country of transit or transhipment, and
  • (ii) all of the information and documents submitted in support of the application are correct and complete.

Additional information and documents

(3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Issuance

43 (1) Subject to section 45, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains

• (a) the permit number;
• (b) the information set out in paragraphs 42(1)(a) to (i) and the number of the import authorization referred to in paragraph 42(1)(j);
• (c) the effective date of the permit;
• (d) the expiry date of the permit, being the earliest of
  • (i) a date specified by the Minister that is not more than 180 days after its effective date,
  • (ii) the expiry date of the dealer’s licence, and
  • (iii) the expiry date of the import authorization issued by the competent authority in the country of final destination; and
• (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to
  • (i) ensure that an international obligation is respected, or
  • (ii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Permit Integrity

(2) A person must not alter or deface in any manner an export permit.

Validity

44 An export permit is valid until the earliest of

• (a) the expiry date set out in the permit,
• (b) the date of the suspension or revocation of the permit under section 48 or 49,
• (c) the date of the suspension or revocation of the dealer’s licence under section 32 or 33, and
• (d) the date of the expiry, suspension or revocation of the import authorization that applies to the controlled substance to be exported and that is issued by the competent authority in the country of final destination.

Refusal

45 (1) The Minister must refuse to issue an export permit if

• (a) the licensed dealer is not authorized by their dealer’s licence to export the relevant controlled substance or their dealer’s licence will expire before the date of export;
• (b) the Minister has reasonable grounds to believe that the exportation would contravene an international obligation;
• (c) the licensed dealer has not provided the Minister with the information or documents required under subsection 42(3) or by the date specified in the written request referred to in that subsection, or the information or documents that they have provided by that date are not sufficient to complete the review of the permit application;
• (d) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application;
• (e) the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import authorization issued by the competent authority of the country of final destination;
• (f) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or
• (g) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Notice

(2) Before refusing to issue the export permit, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Providing copy of permit

46 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.

Declaration

47 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled substance specified in the permit, with a declaration that contains the following information:

• (a) their name and, if applicable, title;
• (b) their dealer’s licence number and the number of the export permit;
• (c) in the case of a controlled substance set out in any of Schedules 1 to 4,
  • (i) its name as set out in the dealer’s licence,
  • (ii) if it is a salt, the name of the salt,
  • (iii) its form, and
  • (iv) its quantity;
• (d) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any; and
• (e) the name of the customs office from which the controlled substance was exported and the date of export.

Suspension

48 (1) The Minister must suspend an export permit without prior notice if

• (a) the dealer’s licence is suspended;
• (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or
• (c) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.

Notice

(2) The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that

• (a) sets out the reasons for the suspension;
• (b) gives the dealer an opportunity to be heard; and
• (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

Reinstatement of permit

(3) The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Revocation

49 (1) The Minister must revoke an export permit if

• (a) the dealer’s licence has been revoked;
• (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
• (c) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 48(2)(c) by the specified date; or
• (d) the Minister has reasonable grounds to believe that the licensed dealer submitted misleading information or falsified documents in or in support of the application for the permit.

Notice

(2) Before revoking an export permit, the Minister must provide the licensed dealer with a written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Authorizations and General Conditions Applicable to Activities

Authorized activities

50 A licensed dealer may conduct the following activities if they do so in accordance with their dealer’s licence and any permit issued under these Regulations:

• (a) produce a controlled substance;
• (b) sell or provide a controlled substance to
  • (i) another licensed dealer,
  • (ii) with the exception of a restricted drug, a pharmacist, other than one who is practising in a hospital,
  • (iii) a practitioner,
  • (iv) with the exception of a restricted drug, a hospital,
  • (v) a person who is exempted under subsection 56(1) of the Act with respect to that controlled substance, if there are terms and conditions for the sale or provision by a licensed dealer that are specified in the exemption, or
  • (vi) the Minister;
• (c) transport, send or deliver a controlled substance; or
• (d) import or export a controlled substance.

Packaging — conditions

51 A licensed dealer that packages a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Destruction

52 A licensed dealer specialized in destruction that destroys a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Qualified person in charge present

53 A licensed dealer may conduct an activity in relation to a controlled substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Identification

54 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themselves in regard to their activities in relation to controlled substances, including labels, shipping documents, invoices and advertising.

Information and documents

55 A licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any relevant information or document to demonstrate their compliance with the Act and these Regulations.

Sale of Controlled Substances

Sale to another licensed dealer

56 (1) A licensed dealer that sells or provides a controlled substance, other than a restricted drug, to another licensed dealer may only do so if they first receive from the other licensed dealer a written order that is signed and dated and that contains the information set out in subsection (3).

Restricted drugs

(2) A licensed dealer that sells or provides a restricted drug to another licensed dealer may only do so if

• (a) the other licensed dealer is specialized in destruction; and
• (b) the licensed dealer first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (3).

Written orders

(3) The information that must be contained in the written order is the following:

• (a) with respect to the other licensed dealer placing the order, their name and, if applicable, title, as well as their municipal address;
• (b) with respect to the licensed dealer selling or providing the controlled substance, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any; and
• (f) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Sale to a pharmacist

57 (1) A licensed dealer that sells or provides a controlled substance to a pharmacist may only do so if they first receive from the pharmacist a written order that is signed and dated and that contains the following information:

• (a) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
• (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Exception — prohibition

(2) A licensed dealer must not sell or provide to the pharmacist a controlled substance that is the subject of a prohibition on the pharmacist’s professional practice imposed by the provincial professional licensing authority.

Sale to a practitioner

58 (1) A licensed dealer that sells or provides a controlled substance, other than a restricted drug, to a practitioner may only do so if they first receive from the practitioner a written order that is signed and dated and that contains the following information:

• (a) with respect to the practitioner, their name and the name and municipal address of the place where they practise;
• (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Restricted drugs

(2) A licensed dealer that sells or provides a restricted drug to a practitioner may only do so if

• (a) the licensed dealer first receives a letter of authorization in which they are named;
• (b) the practitioner is named in the letter of authorization and the municipal address of the place where they practise is specified in that letter; and
• (c) the licensed dealer sells or provides the restricted drug only in the quantity specified in the letter of authorization and, if applicable, in the form and strength specified in that letter.

Exception — prohibition

(3) A licensed dealer must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional licensing authority.

Sale to a hospital

59 A licensed dealer that sells or provides a controlled substance to a hospital may only do so if they first receive from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information:

• (a) with respect to the hospital, its name and municipal address, as well as the name of the person placing the order;
• (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Sale to an exempted person

60 A licensed dealer that sells or provides a controlled substance to a person who is exempted under subsection 56(1) of the Act with respect to that substance may only do so in accordance with the terms and conditions for the sale or provision by the licensed dealer that are specified in the exemption and if they first receive from the exempted person a copy of that exemption.

Sale to Minister

61 A licensed dealer that sells or provides a controlled substance to the Minister may only do so if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
• (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address and licence number;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Anticipated multiple sales

62 (1) A licensed dealer that sells or provides a controlled substance, other than a restricted drug, may do so more than once in respect of one order, within six months after the order was made, if the order indicates

• (a) the number of sales or provisions;
• (b) the specific quantity for each sale or provision; and
• (c) the intervals between each sale or provision.

Multiple sales — insufficient stock

(2) A licensed dealer may sell or provide a controlled substance more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the substance ordered, in which case the dealer may sell or provide the quantity of the substance that the dealer has available and sell or provide the balance later.

Verification of Identity

Orders

63 A licensed dealer that receives an order from a person for a controlled substance must verify the person’s name and, if applicable, their signature if it is not known to the licensed dealer.

Delivery, Sending and Transportation

Requirements during transport

64 (1) A licensed dealer that takes delivery of a controlled substance that they have imported or that delivers, sends or transports a controlled substance to another person may only do so if they

• (a) ensure that its outermost container is inconspicuous, without any mark identifying its contents, and sealed in such a manner that the container cannot be opened without breaking the seal;
• (b) ensure that all inner containers are sealed in such a manner that they cannot be opened without breaking the seal;
• (c) take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported;
• (d) use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it;
• (e) in the case of an imported controlled substance, deliver, send or transport it directly to the site specified in their licence after it is released under the Customs Act; and
• (f) in the case of a controlled substance that is to be exported, deliver, send or transport it directly from the site specified in their licence to the customs office where it will be exported.

Exception

(2) Subsection (1) does not apply to a test kit that has a registration number.

Security

Protective measures

65 A licensed dealer must take all reasonable measures to ensure the security of any controlled substance, licence or permit in their possession.

Loss or theft — licences and permits

66 A licensed dealer that becomes aware of a loss or theft of their licence or permit must provide a written report to the Minister within the following 72 hours.

Loss or theft — agent or mandatary

67 (1) An agent or mandatary of a licensed dealer who becomes aware of a loss or theft of a controlled substance must notify the licensed dealer immediately.

Written report

(2) A licensed dealer that becomes aware of a loss of a controlled substance that cannot be explained on the basis of normally accepted business activities or of a theft of a controlled substance or that is notified by their agent or mandatary of such a loss or theft, must

• (a) in the case of a loss, provide a written report to the Minister within 72 hours after becoming aware or being notified of the loss; or
• (b) in the case of a theft, provide
  • (i) a written report to a police force within 24 hours after becoming aware or being notified of the theft, and
  • (ii) a written report to the Minister within 72 hours after becoming aware or being notified of the theft, which report must include a confirmation that the report required under subparagraph (i) has been provided.

Suspicious transaction

68 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a controlled substance to an illicit market or use:

• (a) with respect to the licensed dealer,
  • (i) in the case of an individual, their name and, if applicable, title, as well as their municipal address and telephone number, or
  • (ii) in the case of an organization, its name, municipal address and telephone number, as well as the title of the position held by the individual making the report;
• (b) with respect to the other party to the transaction, their name and municipal address;
• (c) details of the transaction, including its date and time, as well as its type;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any; and
• (f) a detailed description of the reasons for the dealer’s suspicions.

Good faith

(2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure

(3) A licensed dealer must not disclose that they have provided the report or disclose details of it with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination

69 A report made under any of sections 66 to 68, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction of Controlled Substances

Destruction at site

70 A licensed dealer that intends to destroy a controlled substance at the site specified in their licence must ensure that the following conditions are met:

• (a) the licensed dealer obtains the prior approval of the Minister;
• (b) the destruction is carried out in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):
  • (i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, or
  • (ii) a person who works for or provides services to the licensed dealer and holds a senior position;
• (c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
• (d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add in printed letters their name and, if applicable, title.

Destruction elsewhere than at site

71 A licensed dealer that intends to destroy a controlled substance elsewhere than at the site specified in their licence must ensure that the following conditions are met:

• (a) the licensed dealer obtains the prior approval of the Minister;
• (b) the licensed dealer takes all reasonable measures to ensure the security of the controlled substance while it is being transported in order to prevent its diversion to an illicit market or use;
• (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods, other than a licensed dealer specialized in destruction, and in the presence of another person working for that business;
• (d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
• (e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the controlled substance was destroyed and containing
  • (i) the municipal address of the place of destruction,
  • (ii) in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity,
  • (iii) in the case of a mixture or finished product,
    • (A) subject to clause (C), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
    • (B) subject to clause (C), the total quantity of the controlled substance contained in it, and
    • (C) if the finished product has been previously returned by an individual to a pharmacist or pharmacy technician for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers,
  • (iv) the method of destruction,
  • (v) the date of destruction, and
  • (vi) the names, in printed letters, and signatures of the person who carried out the destruction and the other person who was present at the destruction.

Application for approval

72 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s approval to destroy a controlled substance:

• (a) their name and, if applicable, title, as well as their municipal address;
• (b) their dealer’s licence number;
• (c) the proposed date of destruction;
• (d) the municipal address of the place of destruction;
• (e) a brief description of the method of destruction;
• (f) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph 70(b) and information establishing that they meet the conditions of that paragraph;
• (g) in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity; and
• (h) in the case of a mixture or finished product,
  • (i) subject to subparagraph (iii), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iii), the total quantity of the controlled substance contained in it, and
  • (iii) if the finished product has been previously returned by an individual to a pharmacist or pharmacy technician for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Signature and attestation

(2) The application must

• (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and
• (b) include an attestation by that person that
  • (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and
  • (ii) all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

Additional information and documents

(3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Approval

73 On completion of the review of the approval application, the Minister must approve the destruction of the controlled substance unless

• (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purpose of paragraph 70(b) do not meet the conditions of that paragraph;
• (b) the Minister has reasonable grounds to believe that the controlled substance would not be destroyed;
• (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application;
• (d) the controlled substance or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or
• (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk that the controlled substance could be diverted to an illicit market or use.

Documents

Information

Substances ordered and received

74 A licensed dealer that orders or receives a controlled substance must record the following information:

• (a) the name and, if applicable, title of the individual placing the order for the controlled substance or receiving it;
• (b) with respect to the person from whom the controlled substance is ordered or received, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the order or receipt;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (e) in the case of a mixture or finished product,
  • (i) subject to subparagraph (iv), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iv), its form, strength, the number of containers and, if applicable, the number of units per container,
  • (iii) subject to subparagraph (iv), its drug identification number, if any, and
  • (iv) if the finished product has been previously returned by an individual to a pharmacist or pharmacy technician for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Substances sold

75 A licensed dealer that sells or provides a controlled substance must record the following information:

• (a) the name and, if applicable, title of the individual selling or providing the controlled substance;
• (b) with respect to the person to whom the controlled substance is sold or provided, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the sale or provision;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (e) in the case of a controlled substance that is a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Substances produced or packaged

76 A licensed dealer that produces or packages a controlled substance must record the following information with respect to the substance:

• (a) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (b) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name and quantity of the controlled substance they use to produce the mixture or finished product, or that is contained in the mixture or finished product that they package,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Substances in stock

77 A licensed dealer that stores a controlled substance must record the following information with respect to the substance:

• (a) in the case of a controlled substance set out in any of Schedules 1 to 4,
  • (i) its name, form and quantity, and
  • (ii) the date on which it is placed in stock; or
• (b) in the case of a mixture or finished product,
  • (i) subject to subparagraph (iv), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iv), its form, strength, the number of containers and, if applicable, the number of units per container,
  • (iii) subject to subparagraph (iv), its drug identification number, if any,
  • (iv) if the finished product has been previously returned by an individual to a pharmacist or pharmacy technician for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers, and
  • (v) the date on which it is placed in stock.

Written orders

78 A licensed dealer that receives a written order for a controlled substance must record the following information:

• (a) the name and, if applicable, title of the individual receiving the order; and
• (b) the date of the order and the date on which it was received.

Transportation

79 A licensed dealer that delivers, sends or transports a controlled substance to another person must record the following information:

• (a) the dealer’s name and, if applicable, title, as well as their municipal address;
• (b) if an agent or mandatary of the dealer delivers, sends or transports the controlled substance, their name;
• (c) with respect to the other person, their name and, if applicable, title;
• (d) the municipal address of the place where the controlled substance will be delivered, sent or transported;
• (e) the date of the delivery, sending or transportation;
• (f) the means of transportation;
• (g) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (h) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Substances imported

80 A licensed dealer that imports a controlled substance must record the following information:

• (a) the name and municipal address of the exporter;
• (b) the country of exportation and any country of transit or transhipment;
• (c) the date of the importation;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Substances exported

81 A licensed dealer that exports a controlled substance must record the following information:

• (a) the name and municipal address of the importer;
• (b) the country of final destination and any country of transit or transhipment;
• (c) the date of the exportation;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (e) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Explainable loss of controlled substance

82 A licensed dealer that becomes aware of a loss of a controlled substance that can be explained on the basis of normally accepted business activities or that is notified by their agent or mandatary of such a loss, must record the following information:

• (a) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
• (b) in the case of a mixture or finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any;
• (c) the date on which the dealer became aware or was notified of the loss; and
• (d) the explanation for the loss.

Destruction

83 A licensed dealer that destroys a controlled substance at the site specified in their licence must record the following information:

• (a) the name and, if applicable, title of the person who carried out the destruction and of the other persons who were present at the destruction;
• (b) the municipal address of the place of destruction;
• (c) the date of destruction;
• (d) the method of destruction;
• (e) in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity; and
• (f) in the case of a mixture or finished product,
  • (i) subject to subparagraph (iii), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iii), the total quantity of the controlled substance contained in it, and
  • (iii) if the finished product has been previously returned by an individual to a pharmacist or pharmacy technician for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Monthly report

84 (1) Subject to subsection (2), a licensed dealer must provide to the Minister, within 15 days after the end of each month, a monthly report that contains the name and quantity of each controlled substance

• (a) that is set out in any of Schedules 1 to 4 that they receive, produce, package, sell, provide, import, export or destroy during the month;
• (b) that is contained in a mixture or finished product that they receive, package, sell, provide, import, export or destroy during the month or that they have used to produce a mixture or finished product during the month;
• (c) that is in the physical inventory taken at the site specified in their licence at the end of the month; and
• (d) that has been lost in the course of conducting activities during the month and whose loss can be explained on the basis of normally accepted business activities.

Non-renewal or revocation of licence

(2) If a licensed dealer’s licence expires without being renewed or is revoked, the dealer must provide to the Minister, within three months after the expiration or revocation, a report in respect of the portion of the month during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Recording Information and Retention and Provision of Documents

Method of recording

85 A licensed dealer that records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.

Documents to retain

86 A licensed dealer and a former licensed dealer must

• (a) keep any document containing the information that they are required to record under these Regulations for two years after the day on which the last record is recorded in the document;
• (b) keep every written order, in sequence as to date and number, for two years after the day on which it is received; and
• (c) keep every declaration, report and letter of authorization for two years after the day on which it is provided or received.

Place

87 The documents must be accessible

• (a) at the site specified in the licensed dealer’s licence; or
• (b) in the case of a document retained by a former licensed dealer, at a place in Canada.

Quality of documents

88 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Providing documents

89 A licensed dealer and a former licensed dealer must provide any documents that the Minister requests in the time and manner that the Minister specifies.

Pharmacists

Non-application

Pharmacists practising in a hospital

90 For the purpose of sections 91 to 122, the terms pharmacist, pharmacy technician and pharmacy intern, as defined in subsection 1(1), are to be read as excluding those who are practising in a hospital, except as otherwise provided.

Sale of Controlled Substances

Sale to a licensed dealer

91 (1) A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a licensed dealer if

• (a) in the case of a controlled substance previously returned by an individual for the purposes of destruction,
  • (i) the licensed dealer is specialized in destruction, and
  • (ii) the pharmacist first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (3); and
• (b) in the case of any other controlled substance, the pharmacist first receives from the licensed dealer a written order that is signed and dated and that contains the information set out in subsection (3).

Restricted drugs

(2) A pharmacist may sell or provide a restricted drug to a licensed dealer if

• (a) the restricted drug was previously returned by an individual for the purposes of destruction;
• (b) the licensed dealer is specialized in destruction; and
• (c) the pharmacist first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (3).

Written orders

(3) The information that must be contained in the written order is the following:

• (a) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
• (b) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
• (e) in the case of a finished product,
  • (i) subject to subparagraph (iv), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iv), its form, strength, the number of containers and, if applicable, the number of units per container,
  • (iii) subject to subparagraph (iv), its drug identification number, if any, and
  • (iv) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and
• (f) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Sale to another pharmacist

92 (1) Subject to subsection (2), a pharmacist may, in the case of an emergency, sell or provide a controlled substance, other than a restricted drug, to another pharmacist if they first receive from the other pharmacist either a written order that is signed and dated and that contains the following information or a verbal order:

• (a) with respect to the other pharmacist placing the order, their name and the name and municipal address of the place where they practise;
• (b) with respect to the pharmacist selling or providing the controlled substance, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any; and
• (f) a declaration from the other pharmacist that they require the controlled substance for emergency purposes.

No emergency

(2) A pharmacist may, in circumstances other than an emergency, sell or provide a controlled substance, other than a restricted drug, to another pharmacist if they do so for the purpose of fulfilling a prescription received by the other pharmacist or if they are ceasing to practise at the place where the sale or provision is conducted and if they first receive from the other pharmacist a written order that is signed and dated and that contains the following information:

• (a) with respect to the other pharmacist placing the order, their name and the name and municipal address of the place where the sale or provision is conducted;
• (b) with respect to the pharmacist selling or providing the controlled substance, their name and the name and municipal address of the place where the sale or provision is conducted;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Exception — prohibition

(3) A pharmacist must not sell or provide to the other pharmacist a controlled substance that is the subject of a prohibition on the other pharmacist’s professional practice imposed by the provincial professional licensing authority.

Sale to a practitioner

93 (1) A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a practitioner if they first receive from the practitioner a written order that is signed and dated and that contains the following information or, in the case of an emergency, either such a written order or a verbal order:

• (a) with respect to the practitioner, their name and the name and municipal address of the place where they practise;
• (b) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Exception — prohibition

(2) A pharmacist must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional licensing authority.

Sale to a hospital

94 A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a hospital if they first receive from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information or, in the case of an emergency, either such a written order or a verbal order from that person:

• (a) with respect to the hospital, its name and municipal address, as well as the name of the person placing the order;
• (b) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Sale to an exempted person

95 A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a person exempted under subsection 56(1) of the Act with respect to that controlled substance if

• (a) the pharmacist first receives from the exempted person a copy of the exemption;
• (b) there are terms and conditions for the sale or provision by the pharmacist that are specified in the exemption; and
• (c) the sale or provision is carried out in accordance with those terms and conditions.

Sale to Minister

96 A pharmacist may sell or provide a controlled substance to the Minister if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
• (b) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Sale to an individual

97 (1) Subject to subsection (2), a pharmacist may sell or provide a controlled substance to an individual for their own use, for the use of another individual or for an animal if

• (a) the controlled substance is in the form of a finished product that does not contain a restricted drug; and
• (b) the pharmacist first receives the following in respect of the controlled substance from one of the following persons:
  • (i) in the case of the individual, a written prescription,
  • (ii) in the case of another pharmacist or a pharmacy technician,
    • (A) a written prescription, or
    • (B) a copy of the document on which the information with respect to a verbal prescription has been recorded under section 113, or
  • (iii) in the case of a practitioner, a written or verbal prescription.

Finished product containing low dose of codeine

(2) A pharmacist may sell or provide, without a prescription, a finished product containing codeine phosphate to an individual if

• (a) the finished product contains
  • (i) in the case of a finished product in solid form, not more than 8 mg or its equivalent of codeine phosphate per unit, or
  • (ii) in the case of a finished product in liquid form, not more than 20 mg or its equivalent of codeine phosphate per 30 mL;
• (b) the finished product contains
  • (i) two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half the regular minimum single dose for each such ingredient, or
  • (ii) three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third the regular minimum single dose for each such ingredient;
• (c) the pharmacist has reasonable grounds to believe that the finished product will only be used for recognized medical purposes; and
• (d) the pharmacist ensures that the following caution or its equivalent is conspicuously and legibly printed on the finished product’s inner label and outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations:

“This product contains codeine and should not be administered to children except on the advice of a physician, dentist or nurse practitioner.”

Compounding of Finished Products

Orders and prescriptions

98 (1) A pharmacist or pharmacy technician may compound a finished product, other than one containing a restricted drug, if they do so for the purpose of fulfilling a prescription and if they first receive the following with respect to the finished product from one of the following persons:

• (a) in the case of an individual, a written prescription;
• (b) in the case of another pharmacist,
  • (i) a written order that is signed and dated and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order,
  • (ii) a written prescription, or
  • (iii) a copy of the document on which the information with respect to a verbal prescription is recorded under section 113;
• (c) in the case of another pharmacy technician,
  • (i) a written prescription, or
  • (ii) a copy of the document on which the information with respect to a verbal prescription is recorded under section 113;
• (d) in the case of a practitioner,
  • (i) if they are not practising in a hospital, a written order that is signed and dated and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order, or
  • (ii) a written or verbal prescription; or
• (e) in the case of a hospital, a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order from that person.

Written orders

(2) The information that must be contained in the written order is the following:

• (a) with respect to the person placing the order,
  • (i) in the case of another pharmacist, their name and the name and municipal address of the place where they practise,
  • (ii) in the case of a practitioner, their name and the name and municipal address of the place where they practise, and
  • (iii) in the case of a hospital, its name and municipal address, as well as the name of the person permitted to place the order on its behalf;
• (b) with respect to the pharmacist or pharmacy technician compounding the finished product, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) with respect to the finished product,
  • (i) its name, and
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container; and
• (e) if applicable, a declaration from the other pharmacist that they require the finished product for emergency purposes.

Prescriptions

Extension of prescription

99 A pharmacist may extend a prescription after having fulfilled all refills authorized in the prescription.

Transfer of prescription

100 A pharmacist or pharmacy technician may transfer a prescription to another pharmacist or pharmacy technician if they provide

• (a) in the case of a controlled substance prescribed in writing, the written prescription; or
• (b) in the case of a controlled substance prescribed verbally, a copy of the document on which the information with respect to that verbal prescription is recorded under section 113.

Verification of Identity

Orders and prescriptions

101 A pharmacist or a pharmacy technician who receives an order or prescription from a person for a controlled substance must verify the person’s name and, if applicable, their signature if it is not known to the pharmacist.

Packaging and Labelling

Receipt of substance from an individual

102 A pharmacist or pharmacy technician who receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that prevents its removal from the container and is marked in a manner that is sufficient to identify the container.

Storage

Authorized access

103 A pharmacist who stores a controlled substance must ensure that

• (a) they store the controlled substance in a secure location at the place where they practise; and
• (b) only persons whom they have authorized have access to that secure location.

Delivery, Sending and Transportation

Authorization

104 A pharmacist or pharmacy technician may deliver, send or transport a controlled substance.

Requirements during transportation

105 A pharmacist or pharmacy technician who delivers, sends or transports a controlled substance to another person must

• (a) ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner sufficient to identify the container;
• (b) take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and
• (c) use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.

Security

Protective measures

106 A pharmacist or pharmacy technician must take all reasonable measures to ensure the security of any controlled substance in their possession.

Loss or theft — agent or mandatary

107 (1) An agent or mandatary of a pharmacist who becomes aware of a loss or theft of a controlled substance must notify the pharmacist immediately.

Written report

(2) A pharmacist who becomes aware of a loss or theft of a controlled substance, or who is notified by their agent or mandatary of such a loss or theft, must provide a written report to the Minister within the following 10 days.

Partial protection against self-incrimination

(3) The report or any evidence derived from it is not to be used or received to incriminate the pharmacist or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction of Controlled Substances

Conditions

108 (1) The destruction of a controlled substance in a pharmacy may only be carried out by a pharmacist or pharmacy technician and if the following conditions are met:

• (a) the destruction is witnessed by another person among the following:
  • (i) a pharmacist, pharmacy technician or pharmacy intern, including one who is practising in a hospital,
  • (ii) a practitioner, or
  • (iii) any other health professional;
• (b) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
• (c) immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.

Substance returned by an individual

(2) A pharmacist must, if the destruction of a controlled substance previously returned by an individual for the purposes of destruction was not carried out, sell or provide the substance to a licensed dealer specialized in destruction.

Documents

Information

Substances ordered and received

109 A pharmacist who orders a controlled substance or who receives a controlled substance, other than one that has been returned by an individual for the purposes of destruction, must record the following information:

• (a) their name;
• (b) with respect to the person from whom the controlled substance is ordered or received, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the order or receipt;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any.

Substances sold — individuals

110 (1) A pharmacist who sells or provides a finished product to an individual for their own use, for the use of another individual or for an animal must record the following information:

• (a) the pharmacist’s name;
• (b) the name and municipal address of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
• (c) the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise;
• (d) the number assigned to the prescription;
• (e) the date of the sale or provision;
• (f) with respect to the finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any; and
• (g) if applicable, the number of times that the prescription may be refilled and, if specified, the intervals between refills.

Substances sold — persons other than individuals

(2) A pharmacist who sells or provides a controlled substance to a person, other than an individual referred to in subsection (1), must record the following information:

• (a) the pharmacist’s name;
• (b) with respect to the person, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the sale or provision;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
• (e) in the case of a finished product,
  • (i) subject to subparagraph (iv), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iv), its form, strength, the number of containers and, if applicable, the number of units per container,
  • (iii) subject to subparagraph (iv), its drug identification number, if any, and
  • (iv) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and
• (f) if applicable, the reason for the emergency sale or provision.

Finished products compounded

111 A pharmacist or pharmacy technician who compounds a finished product must record the following information:

• (a) their name;
• (b) the date of compounding the finished product; and
• (c) with respect to the finished product,
  • (i) its name, and
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container.

Written orders and prescriptions

112 A pharmacist or a pharmacy technician who receives a written order for a controlled substance or a written prescription from a practitioner must record the following information:

• (a) the pharmacist’s or pharmacy technician’s name; and
• (b) the date of the order or prescription and the date on which it was received.

Verbal orders and prescriptions

113 A pharmacist or pharmacy technician who receives a verbal order for a controlled substance or a verbal prescription must record the following information:

• (a) their name;
• (b) with respect to the person placing the order or issuing the prescription,
  • (i) in the case of an order from another pharmacist,
    • (A) their name and the name and municipal address of the place where they practise, and
    • (B) a declaration from the other pharmacist that they require the controlled substance for emergency purposes,
  • (ii) in the case of a prescription or order from a practitioner,
    • (A) their name and the name and municipal address of the place where they practise, and
    • (B) if it is an order, a declaration from the practitioner that they require the controlled substance for emergency purposes, or
  • (iii) in the case of an order from a hospital,
    • (A) its name and municipal address, as well as the name of the person permitted to place the order on its behalf, and
    • (B) a declaration from that person that the hospital requires the controlled substance for emergency purposes;
• (c) the date of receipt of the order or prescription;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container, and
  • (iii) its drug identification number, if any; and
• (f) if applicable, the number of refills authorized in the prescription and, if specified, the interval between refills.

Prescriptions refilled and extended

114 A pharmacist who refills or extends a prescription must record the following information:

• (a) their name;
• (b) the number assigned to the original prescription;
• (c) the date of the prescription refill or extension; and
• (d) if applicable, the new expiration date of the extended prescription.

Prescription transfers — transferring pharmacist

115 (1) A pharmacist or pharmacy technician who transfers a prescription to another pharmacist or pharmacy technician must record the following information:

• (a) their name;
• (b) with respect to the other pharmacist or pharmacy technician, their name and the name and municipal address of the place where they practise;
• (c) the number assigned to the prescription;
• (d) the date of the prescription transfer;
• (e) the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and the specified interval between refills; and
• (f) if applicable, the date of the prescription extension and the new expiration date of the extended prescription.

Pharmacist receiving transfer

(2) The pharmacist or pharmacy technician who receives the transferred prescription must record the following information:

• (a) their name;
• (b) with respect to the pharmacist or pharmacy technician from whom they receive the transferred prescription, their name and the name and municipal address of the place where they practise;
• (c) the number assigned to the prescription;
• (d) the date of receipt of the prescription;
• (e) the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and the specified interval between refills; and
• (f) if applicable, the date of the prescription extension and the new expiration date of the extended prescription.

Transportation

116 A pharmacist who delivers, sends or transports a controlled substance must record the following information:

• (a) their name and the name and municipal address of the place where they practise;
• (b) if an agent or mandatary of the pharmacist delivers, sends or transports the controlled substance, their name;
• (c) if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:
  • (i) if they are not a person referred to in subparagraph (ii), their name and, if applicable, title, or
  • (ii) if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal;
• (d) the municipal address of the place where the controlled substance is delivered, sent or transported;
• (e) the date of the delivery, sending or transportation and, if applicable, the date on which the pharmacist ceased practising at the place from where the controlled substance was delivered, sent or transported;
• (f) the means of transportation;
• (g) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (h) in the case of a finished product,
  • (i) subject to subparagraph (iv), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iv), its form, strength, the number of containers and, if applicable, the number of units per container,
  • (iii) subject to subparagraph (iv), its drug identification number, if any, and
  • (iv) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Destruction

117 A pharmacist or pharmacy technician who destroys a controlled substance must record the following information:

• (a) their name;
• (b) the name of the witness to the destruction;
• (c) the municipal address of the place of destruction;
• (d) the date of destruction;
• (e) the method of destruction;
• (f) in the case of a controlled substance set out in any of Schedules 1 to 3, its name and quantity; and
• (g) in the case of a finished product,
  • (i) subject to subparagraph (iii), its name or, if applicable, its brand name, as well as the name of the controlled substance contained in it,
  • (ii) subject to subparagraph (iii), the total quantity of the controlled substance contained in it, and
  • (iii) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Recording Information and Retention and Provision of Documents

Method of recording

118 A pharmacist or pharmacy technician who records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.

Documents to retain

119 (1) Subject to subsection (2), a pharmacist and a pharmacy technician, including one who is no longer practising, must

• (a) keep any document containing the information that they are required to record under these Regulations for two years after the day on which the last record is recorded in the document;
• (b) keep every written order and prescription, in sequence as to date and number, for two years after the day on which it is received; and
• (c) keep every declaration and report for two years after the day on which it is provided or received.

Substances sold or provided

(2) All documents regarding the sale or provision of controlled substances must be kept separately, in sequence as to date and number.

Place

120 The documents must be accessible

• (a) at the place where the pharmacist or pharmacy technician practises; or
• (b) in the case of a document retained by a pharmacist or pharmacy technician who is no longer practising, at a place in Canada.

Quality of documents

121 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Providing documents

122 A pharmacist and a pharmacy technician, including one who is no longer practising, must provide any documents that the Minister requests in the time and manner that the Minister specifies.

Practitioners

Prescriptions

Prescriptions

123 A practitioner may issue a written prescription that they sign and date or a verbal prescription if

• (a) the practitioner is treating, in their professional capacity, the individual for whom or animal for which the prescription is issued; and
• (b) the controlled substance set out in the prescription is needed to treat the individual’s or animal’s medical condition.

Sale of Controlled Substances

Sale to a licensed dealer

124 A practitioner may sell or provide a controlled substance to a licensed dealer if they first receive from that licensed dealer a written order that is signed and dated and that contains the following information:

• (a) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
• (b) with respect to the practitioner, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any; and
• (f) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Sale to Minister

125 A practitioner may sell or provide a controlled substance to the Minister if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
• (b) with respect to the practitioner, their name and the name and municipal address of the place where they practise;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Sale to an individual

126 (1) A practitioner may sell or provide a controlled substance, other than a restricted drug, to an individual for their own use, for the use of another individual or for an animal if they first issue a written prescription for the individual for whom or animal for which the controlled substance is sold or provided.

Restricted drugs

(2) A practitioner may sell or provide a restricted drug to an individual for their own use if

• (a) the practitioner is treating the individual in their professional capacity; and
• (b) the practitioner has received a copy of the letter of authorization in which they are named.

Administration of Controlled Substances

General conditions

127 (1) A practitioner may administer a controlled substance, other than a restricted drug, to an individual or animal if the practitioner first issues a written prescription.

Restricted drugs

(2) A practitioner may administer a restricted drug to an individual if

• (a) the practitioner is treating the individual in their professional capacity; and
• (b) the practitioner has received a copy of the letter of authorization in which they are named.

Emergency supply

128 (1) A practitioner of medicine who is responsible for an emergency supply must ensure that

• (a) the emergency supply does not contain a restricted drug; and
• (b) they have an agent or mandatary who is present at the place where the emergency supply is stored and who will, under their direction, administer the controlled substances under their control.

Administration — conditions

(2) In an emergency, the agent or mandatary of the practitioner of medicine may administer a controlled substance from the emergency supply to an individual if

• (a) the practitioner of medicine has directed the agent or mandatary to administer the controlled substance; or
• (b) the agent or mandatary follows written directives provided by the practitioner of medicine with respect to the administration of the controlled substance.

Storage

Authorized access

129 (1) Subject to subsection (2), a practitioner who stores a controlled substance must ensure that

• (a) they store the controlled substance in a secure location in the place where they practise; and
• (b) only persons whom they have authorized have access to that secure location.

Emergency supply

(2) A practitioner of medicine who stores an emergency supply need only ensure that

• (a) they take all reasonable measures to ensure that the place of storage is secure; and
• (b) only the practitioner of medicine and their agent or mandatary have access to that secure place.

Delivery, Sending and Transport

Authorization

130 A practitioner may deliver, send or transport a controlled substance.

Requirements during transportation

131 A practitioner who delivers, sends or transports a controlled substance to another person must

• (a) ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner that is sufficient to identify the container;
• (b) take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and
• (c) use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.

Security

Protective measures

132 A practitioner must take all reasonable measures to ensure the security of any controlled substance in their possession.

Loss or theft — agent or mandatary

133 (1) An agent or mandatary of a practitioner who becomes aware of a loss or theft of a controlled substance must notify the practitioner immediately.

Written report

(2) A practitioner who becomes aware of a loss or theft of a controlled substance, or who is notified by their agent or mandatary of such a loss or theft, must provide a written report to the Minister within the following 10 days.

Partial protection against self-incrimination

(3) The report or any evidence derived from it is not to be used or received to incriminate the practitioner or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction of Controlled Substances

Conditions

134 A practitioner who destroys a controlled substance may only do so if

• (a) the destruction is witnessed by another person among the following:
  • (i) a pharmacist, pharmacy technician or pharmacy intern,
  • (ii) a practitioner, or
  • (iii) any other health professional;
• (b) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
• (c) immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.

Documents

Application

Scope

135 The requirements set out in sections 136 to 147 apply to a practitioner with respect to the following controlled substances:

• (a) if the practitioner is not practising in a hospital, a narcotic, controlled drug or targeted substance; and
• (b) a restricted drug.

Information

Substances received

136 A practitioner who receives a controlled substance must record the following information:

• (a) with respect to the person from whom the controlled substance is received, their name and, if applicable, title, as well as their municipal address;
• (b) the date of receipt;
• (c) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (d) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Substances sold — persons other than individuals

137 A practitioner who sells or provides a controlled substance to a person, other than an individual referred to in section 138, must record

• (a) the practitioner’s name;
• (b) with respect to the person, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the sale or provision;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Substances prescribed, administered or sold — individuals

138 (1) A practitioner who conducts the following activities must record the information set out in subsection (2):

• (a) prescribe or administer a controlled substance to an individual or an animal; or
• (b) sell or provide a controlled substance to an individual for their own use, for the use of another individual or for an animal.

Information

(2) The information that must be recorded is the following:

• (a) the practitioner’s name;
• (b) the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
• (c) in the case of an administration, sale or provision of a restricted drug to an individual, their name;
• (d) the date of the prescription, administration, sale or provision;
• (e) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
• (f) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity,
  • (iii) its drug identification number, if any, and
  • (iv) if the finished product that is sold or provided, other than one containing a restricted drug, is intended for administration by the individual to themselves or the animal, and if the dose exceeds the following, a statement to that effect:
    • (A) in the case of a finished product containing a controlled drug or narcotic, three times the maximum daily dosage recommended by the producer of the substance or, if the producer has not recommended a maximum daily dosage, three times the generally recognized maximum daily therapeutic dosage for that product, or
    • (B) in the case of a finished product containing a targeted substance, five times the usual daily dose for the product.

Emergency supply

139 A practitioner of medicine who is responsible for an emergency supply must record the following information:

• (a) the name of their agent or mandatary administering the controlled substance;
• (b) the place where the emergency supply is stored;
• (c) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
• (d) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any;
• (e) the date of all activities related to that emergency supply; and
• (f) if a controlled substance was administered to an individual, the following information:
  • (i) the name of the individual,
  • (ii) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity, and
  • (iii) in the case of a finished product,
    • (A) its name or, if applicable, its brand name,
    • (B) its form, strength and quantity, and
    • (C) its drug identification number, if any.

Written orders

140 A practitioner who receives a written order must record the following information:

• (a) their name; and
• (b) the date of the order and the date on which it was received.

Transportation

141 A practitioner who delivers, sends or transports a controlled substance must record the following information:

• (a) their name and the name and municipal address of the place where they practise;
• (b) if an agent or mandatary of the practitioner delivers, sends or transports the controlled substance, their name;
• (c) if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:
  • (i) if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal,
  • (ii) if they are a consignee of a restricted drug, their name, or
  • (iii) in any other case, their name and, if applicable title;
• (d) the municipal address of the place where the controlled substance is delivered, sent or transported;
• (e) the date of the delivery, sending or transportation;
• (f) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
• (g) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Destruction

142 A practitioner who destroys a controlled substance must record the following information:

• (a) their name;
• (b) the name of the witness to the destruction;
• (c) the municipal address of the place of destruction;
• (d) the date of destruction;
• (e) the method of destruction;
• (f) in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity; and
• (g) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, and
  • (ii) its quantity.

Recording Information and Retention and Provision of Documents

Method of recording

143 A practitioner who records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.

Documents to retain

144 A practitioner must

• (a) keep any document containing the information that they are required to record under these Regulations for two years after the day on which the last record is recorded in the document;
• (b) keep every written order and prescription, in sequence as to date and number, for two years after the day on which it is received or issued respectively; and
• (c) keep every declaration, report and letter of authorization for two years after the day on which it is provided or received.

Place

145 The documents must be accessible at the place where the practitioner practises.

Quality of documents

146 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Providing documents

147 A practitioner must provide any documents that the Minister requests in the time and manner that the Minister specifies.

Prescribed Practitioners

Additional conditions

148 In addition to meeting any other requirements set out in these Regulations, the following practitioners who, in accordance with these Regulations and subject to section 149, conduct any activity with respect to a controlled substance, other than a restricted drug, may only do so if they are authorized by the provincial professional licensing authority to conduct that activity:

• (a) a midwife;
• (b) a podiatrist; and
• (c) a nurse practitioner.

Midwife and podiatrist

149 A midwife or podiatrist must not possess or conduct any activity with respect to the following controlled substances:

• (a) a narcotic set out in subitems 1(1) or (10), 2(1), 5(4) or 10(1) of Schedule 1; or
• (b) a controlled drug set out in items 1, 4 or 5 of Part 1 of Schedule 2 or item 1 of Part 3 of that Schedule.

Hospitals

Application and General Conditions for Activities

Application

150 For the purpose of sections 152 to 181, the terms pharmacist, pharmacy technician, pharmacy intern and health professional, as defined in subsection 1(1) of these Regulations, and practitioner, as defined in subsection 2(1) of the Act, are to be read as only including those who are practising in a hospital, except as otherwise provided.

Non-application — restricted drugs

151 For the purpose of sections 152 to 181, the term controlled substance, as defined in subsection 2(1) of the Act, is to be read as excluding a restricted drug.

Person in charge

152 A person in charge of a hospital may permit another person to conduct an activity with respect to a controlled substance if

• (a) in the case that the other person is a health professional, they are authorized by the provincial professional licensing authority to conduct that activity; or
• (b) the other person conducts that activity as part of their duties and functions.

Orders placed on behalf of hospital

153 A person in charge of a hospital may only permit the pharmacist in charge of the hospital pharmacy or a practitioner to order controlled substances for the hospital.

Sale of Controlled Substances

Sale to a licensed dealer

154 A hospital may sell or provide a controlled substance to a licensed dealer if they first receive from that licensed dealer a written order that is signed and dated and that contains the following information:

• (a) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
• (b) with respect to the hospital, its name and municipal address;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any; and
• (f) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Sale to a pharmacist

155 (1) A hospital may sell or provide a controlled substance to a pharmacist, other than one who is practising in a hospital, if

• (a) the sale or provision is in the case of an emergency; and
• (b) the hospital first receives from the pharmacist either a written order that is signed and dated and that contains the following information or a verbal order:
  • (i) with respect to the pharmacist, their name and, the name and municipal address of the place where they practise,
  • (ii) with respect to the hospital, its name and municipal address,
  • (iii) the date of the order,
  • (iv) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity,
  • (v) in the case of a finished product,
    • (A) its name or, if applicable, its brand name,
    • (B) its form, strength and quantity, and
    • (C) its drug identification number, if any, and
  • (vi) a declaration from the pharmacist that they require the controlled substance for emergency purposes.

Exception — prohibition

(2) A hospital must not sell or provide to the pharmacist a controlled substance that is the subject of a prohibition on the pharmacist’s professional practice imposed by the provincial professional licensing authority.

Sale to a practitioner

156 (1) A hospital may sell or provide a controlled substance to a practitioner, other than one who is practising in a hospital, if

• (a) the sale or provision is in the case of an emergency; and
• (b) the hospital first receives from the practitioner either a written order that is signed and dated and that contains the following information or a verbal order:
  • (i) with respect to the practitioner, their name and the name and municipal address of the place where they practise,
  • (ii) with respect to the hospital, its name and municipal address,
  • (iii) the date of the order,
  • (iv) in the case of a controlled substance set out any of Schedules 1 to 3, its name, form and quantity,
  • (v) in the case of a finished product,
    • (A) its name or, if applicable, its brand name,
    • (B) its form, strength and quantity, and
    • (C) its drug identification number, if any, and
  • (vi) a declaration from the practitioner that they require the controlled substance for emergency purposes.

Exception — prohibition

(2) A hospital must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional licensing authority.

Sale to another hospital

157 A hospital may sell or provide a controlled substance to another hospital if

• (a) the sale or provision is in the case of an emergency; and
• (b) the hospital first receives from the other hospital either a written order that is signed and dated by the person permitted to place an order on its behalf and that contains the following information or a verbal order from that person:
  • (i) with respect to the other hospital placing the order, its name, municipal address, as well as the name of the person placing the order,
  • (ii) with respect to the hospital selling or providing the controlled substance, its name and municipal address,
  • (iii) the date of the order,
  • (iv) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity,
  • (v) in the case of a finished product,
    • (A) its name or, if applicable, its brand name,
    • (B) its form, strength and quantity, and
    • (C) its drug identification number, if any, and
  • (vi) a declaration from the other hospital that it requires the controlled substance for emergency purposes.

Sale to Minister

158 A hospital may sell or provide a controlled substance to the Minister if the hospital first receives from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
• (b) with respect to the hospital, its name and municipal address;
• (c) the date of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Sale to an individual

159 A hospital may sell or provide a controlled substance to an individual if

• (a) the sale or provision is for the individual’s own use, for the use of another individual or for an animal; and
• (b) a practitioner first issues a written or verbal prescription for the individual for whom or animal for which the controlled substance is sold or provided.

Administration to Individual

Conditions

160 A hospital may administer a controlled substance to an individual or animal if a practitioner first issues a written or verbal prescription.

Compounding of Finished Products

Orders and prescriptions

161 (1) A hospital may compound a finished product if it is for the purpose of fulfilling a prescription and,

• (a) if the finished product is compounded at the request of a practitioner, that practitioner first issues a written or verbal prescription; or
• (b) if the finished product is compounded at the request of one of the following persons, in the case of an emergency, the hospital first receives from that person either a written order that is signed and dated and that contains the information set out in subsection (2) or a verbal order:
  • (i) a pharmacist who is not practising in that or another hospital,
  • (ii) a practitioner who is not practising in that or another hospital, or
  • (iii) another hospital, if the order is placed by a person permitted to place an order on its behalf.

Written orders

(2) The information that must be contained in the written order is the following:

• (a) with respect to the person placing the order,
  • (i) if they are a pharmacist, their name and the name and municipal address of the place where they practise,
  • (ii) if they are a practitioner, their name and the name and municipal address of the place where they practise, and
  • (iii) if it is another hospital, its name and municipal address, as well as the name of the person permitted to place the order on its behalf;
• (b) with respect to the hospital receiving the order, its name and municipal address;
• (c) the date of the order;
• (d) with respect to the finished product,
  • (i) its name, and
  • (ii) its form, strength and quantity; and
• (e) a declaration from the person placing the order that they require the finished product for emergency purposes.

Verification of Identity

Orders

162 A hospital that receives an order from a person for a controlled substance must verify the person’s name and, if applicable, their signature if it is not known to the hospital.

Storage

Authorized access

163 A hospital that stores a controlled substance must ensure that

• (a) the controlled substance is stored in a secure location in the hospital; and
• (b) only persons whom it has authorized have access to that secure location.

Delivery, Sending and Transport

Authorization

164 A hospital may deliver, send or transport a controlled substance.

Requirements during transportation

165 A hospital that delivers, sends or transports a controlled substance to another person must

• (a) ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner that is sufficient to identify the container;
• (b) take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and
• (c) use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.

Security

Protective measures

166 A hospital must take all reasonable measures to ensure the security of any controlled substance in its possession.

Loss or theft — agent or mandatary

167 (1) An agent or mandatary of a hospital who becomes aware of a loss or theft of a controlled substance must notify the hospital immediately.

Written report

(2) A hospital that becomes aware of a loss or theft of a controlled substance, or that is notified by its agent or mandatary of such a loss or theft, must provide a written report to the Minister within the following 10 days.

Partial protection against self-incrimination

(3) The report or any evidence derived from it is not to be used or received to incriminate the hospital or its agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction of Controlled Substances

Conditions

168 (1) The destruction of a controlled substance in a hospital may only be carried out, subject to subsection (2), by the person in charge of the hospital, a pharmacist, a pharmacy technician or a practitioner and if the following conditions are met:

• (a) the destruction is witnessed by another person among the following:
  • (i) a pharmacist, pharmacy technician or pharmacy intern,
  • (ii) a practitioner,
  • (iii) any other health professional, or
  • (iv) the person in charge of the hospital;
• (b) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
• (c) immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.

Exception — open ampule

(2) A practitioner or other health professional may, without a witness, destroy the remainder of a controlled substance that is contained in an open ampule and that will not be administered.

Documents

Information

Substances received

169 A hospital that receives a controlled substance must record the following information:

• (a) the name of the person receiving the controlled substance;
• (b) with respect to the person from whom the controlled substance is received, their name and, if applicable, title, as well as their municipal address;
• (c) the date of receipt;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Substances sold — persons other than individuals

170 A hospital that sells or provides a controlled substance to a person, other than an individual referred to in section 171, must record the following information:

• (a) the name of the person selling or providing the controlled substance;
• (b) with respect to the person to whom the controlled substance is sold or provided, their name and, if applicable, title, as well as their municipal address;
• (c) the date of the sale or provision;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any; and
• (f) if applicable, the reason for the emergency sale or provision.

Substances sold or administered — individuals

171 A hospital that sells or provides a controlled substance to an individual for their own use, for the use of another individual or for an animal, or that administers a controlled substance to an individual or an animal, must record the following information:

• (a) the name of the person selling, providing or administering the controlled substance;
• (b) the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
• (c) the date of the sale, provision or administration;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Finished products compounded

172 A hospital that compounds a finished product must record the following information:

• (a) the name of the person compounding the finished product;
• (b) the date of compounding; and
• (c) with respect to the finished product,
  • (i) its name, and
  • (ii) its form, strength and quantity.

Written orders

173 A hospital that receives a written order for a controlled substance must record the following information:

• (a) the name of the person receiving the order; and
• (b) the date of the order and the date on which it was received.

Verbal orders

174 A hospital that receives a verbal order for a controlled substance must record the following information:

• (a) the name of the person receiving the order;
• (b) with respect to the person placing the order,
  • (i) their name, municipal address and, in the case of another hospital, the name of the person permitted to place the order on its behalf, and
  • (ii) a declaration that they require the controlled substance for emergency purposes or, in the case of another hospital, a declaration from the person placing the order that the hospital requires the controlled substance for emergency purposes;
• (c) the date of receipt of the order;
• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (e) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Transportation

175 A hospital that delivers, sends or transports a controlled substance must record the following information:

• (a) its name and municipal address;
• (b) with respect to the agent or mandatary of the hospital delivering, sending or transporting the controlled substance, their name;
• (c) if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:
  • (i) if they are not a person referred to in subparagraph (ii), their name and, if applicable, title, or
  • (ii) if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal;
• (d) the municipal address of the place where the controlled substance will be delivered, sent or transported;
• (e) the date of the delivery, sending or transportation and, if applicable, the date the hospital has ceased operating;
• (f) the means of transportation used;
• (g) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
• (h) in the case of a finished product,
  • (i) its name or, if applicable, its brand name,
  • (ii) its form, strength and quantity, and
  • (iii) its drug identification number, if any.

Destruction

176 A person who destroys a controlled substance in a hospital must record the following information:

• (a) their name;
• (b) the name of the witness to the destruction;
• (c) the municipal address of the hospital;
• (d) the date of destruction;
• (e) the method of destruction;
• (f) in the case of a controlled substance set out in any of Schedules 1 to 3, its name and quantity; and
• (g) in the case of a finished product,
  • (i) its name or, if applicable, its brand name, and
  • (ii) its quantity.

Recording Information and Retention and Provision of Documents

Method of recording

177 Any person who records any information under sections 169 to 176 must do so using a method that permits an audit of it to be made at any time.

Documents to retain

178 A hospital must

• (a) keep any document containing the information that is required to be recorded under sections 169 to 176 for two years after the day on which the last record is recorded in the document;
• (b) keep every written order and prescription, in sequence as to date and number, for two years after the day on which it is received or issued respectively; and
• (c) keep every declaration and report for two years after the day on which it is provided or received.

Place

179 The documents must be accessible at the hospital.

Quality of documents

180 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Providing documents

181 A hospital must provide any documents that the Minister requests in the time and manner that the Minister specifies.

Minister

Communication of information to licensing authority

182 The Minister must provide in writing any factual information that has been obtained under the Act or these Regulations about a pharmacist, pharmacy technician, practitioner or any other health professional to the provincial professional licensing authority that is responsible for authorizing the person to practise their profession

• (a) in the province in which the person is or was entitled to practise if
  • (i) the authority submits to the Minister a written request that sets out the name and municipal address of the person, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or
  • (ii) the Minister has reasonable grounds to believe that the person has
    • (A) contravened a rule of conduct established by the authority,
    • (B) been convicted of a designated substance offence, or
    • (C) contravened these Regulations; or
• (b) in a province in which the person is not entitled to practise if the authority submits to the Minister
  • (i) a written request that sets out the person’s name and municipal address and a description of the information being requested, and
  • (ii) a document that shows that
    • (A) the person has applied to that authority to practise in that province, or
    • (B) the authority has reasonable grounds to believe that the person is practising in that province without being authorized to do so.

Provision of information to customs officer

183 The Minister may, for the purpose of verifying whether an importation or exportation of a controlled substance complies with these Regulations, provide the following to a customs officer:

• (a) information provided in the permit application under sections 34 or 42;
• (b) information listed on the permit pursuant to subsections 35(1) or 43(1);
• (c) information provided in the declaration under sections 39 or 47; or
• (d) information concerning the suspension or revocation of an import or export permit.

Communication of information to International Narcotics Control Board

184 The Minister may provide to the International Narcotics Control Board any information that is obtained under the Act or these Regulations if the provision is necessary to enable Canada to fulfill its international obligations in relation to controlled substances.

Provision of information to competent authorities

185 The Minister may, for the purposes of the administration or enforcement of the Act or these Regulations or if it is necessary to enable Canada to fulfill its international obligations in relation to controlled substances, provide to a competent authority

• (a) information obtained from a licensed dealer that has applied for or that holds an import or export permit;
• (b) information relating to
  • (i) an import or export permit, or
  • (ii) an activity specified on a dealer’s licence held by a licensed dealer that has applied for or that holds an import or export permit;
• (c) any document that the holder or former holder of an import or export permit is required to retain, including any document that relates to the dealer’s licence that they hold or held; and
• (d) a copy of any import or export permit.

Restricted drugs — temporary accelerated scheduling

186 (1) The Minister may, by order, add to Part 3 of Schedule 4 to these Regulations any item or portion of an item listed in Schedule V to the Act.

Deletion

(2) The Minister may, by order, delete any item or portion of an item from Part 3 of Schedule 4.

Deletion — Schedule V to Act

(3) An item or portion of an item listed in Part 3 of Schedule 4 to these Regulations is deemed to be deleted on the day on which the equivalent item or portion of an item is no longer listed in Schedule V to the Act.

Individuals

Transport and provision

187 An individual who has obtained, in accordance with the Act and its regulations, a controlled substance specified in a prescription for another individual named in that prescription may deliver, transport, sell or provide the substance to that individual.

Return to a pharmacist for destruction

188 An individual who has reasonable grounds to believe that a controlled substance in their possession was obtained in accordance with the Act and its regulations may deliver, transport, sell or provide the substance directly to a pharmacist or pharmacy technician, other than one who is practising in a hospital, for the purposes of destruction.

Importation

189 On entering Canada, an individual may import a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if

• (a) the individual is importing the substance
  • (i) for their own use,
  • (ii) for the use and on the behalf of an accompanying individual, or
  • (iii) for administration to an animal for which the individual is responsible and that is accompanying the individual;
• (b) the substance is declared to a customs officer at the port of entry into Canada;
• (c) the substance is in a container carrying a label on which the following information appears:
  • (i) the name of the individual for whom or animal for which the substance was lawfully obtained,
  • (ii) the name of the medical professional who authorized the substance to be obtained,
  • (iii) with respect to the substance,
    • (A) its name or, if applicable, its brand name,
    • (B) its form, strength and quantity, and
    • (C) its drug identification number, if any, and
  • (iv) the daily dose of the substance authorized by the medical professional; and
• (d) the imported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.

Export

190 On departing Canada, an individual may export a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if

• (a) the individual is exporting the substance
  • (i) for their own use,
  • (ii) for the use and on the behalf of an accompanying individual, or
  • (iii) for administration to an animal for which the individual is responsible and that is accompanying the individual;
• (b) the substance is in a container carrying a label on which the following information appears:
  • (i) the name of the individual for whom or animal for which the substance was lawfully obtained,
  • (ii) the name of the medical professional who authorized the substance to be obtained,
  • (iii) with respect to the substance,
    • (A) its name or, if applicable, its brand name,
    • (B) its form, strength and quantity, and
    • (C) its drug identification number, if any, and
  • (iv) the daily dose of the substance authorized by the medical professional; and
• (c) the exported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.

Test Kits

Application

191 Only sections 1, 7 to 33 and 192 to 198 apply to a test kit.

Requirement to obtain a registration number

192 The following persons are required to obtain a registration number for a test kit:

• (a) a person that intends to produce a test kit; and
• (b) a person for whom another person, in accordance with a custom order, intends to produce a test kit.

Application for registration number

193 (1) An application to obtain a registration number for a test kit must be submitted to the Minister and contain the following information with respect to the test kit:

• (a) its brand name;
• (b) a detailed description of its design and construction;
• (c) with respect to the controlled substance set out in any of Schedules 1 to 4 and any other substance it contains, their names, forms and quantities;
• (d) a description of its proposed use; and
• (e) its directions for use.

Signature and attestation

(2) The application must

• (a) be signed and dated by the person authorized by the applicant for that purpose; and
• (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.

Additional information and documents

(3) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Issuance of registration number

194 (1) Subject to section 195, on completion of the review of the application for a registration number, the Minister must issue to the applicant a document that sets out a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Registration number integrity

(2) A person must not alter or deface in any manner the document that sets out the registration number.

Refusal to issue registration number

195 (1) The Minister must refuse to issue a registration number for a test kit if the Minister has reasonable grounds to believe that

• (a) the test kit poses a risk to public health or safety, including the risk that the controlled substance in the test kit could be diverted to an illicit market or use, because
  • (i) the total amount of the controlled substance is too high, or
  • (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter the consumption of the controlled substance in the test kit by an individual or animal or the administration of that substance to an individual or animal; or
• (b) the test kit will be used for a purpose other than one referred to in subsection 194(1).

Notice

(2) Before refusing to issue a registration number, the Minister must provide the applicant with a written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

Notice to Minister

196 A person must inform the Minister in writing of any of the following facts within 30 days after their occurrence:

• (a) they have ceased to conduct all activities authorized under section 198 with respect to the test kit;
• (b) they have transferred the production of the test kit to another person;
• (c) they have increased the quantity of the controlled substance in the test kit;
• (d) they have changed the brand name of the test kit;
• (e) they have altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or
• (f) they have substituted the adulterating or denaturing agent with another one.

Cancellation of registration number

197 (1) The Minister must cancel the registration number of a test kit if

• (a) the Minister receives a notice from the person to whom the document that sets out the registration number was issued, stating that production of the test kit has ceased; or
• (b) the Minister has reasonable grounds to believe that one of the circumstances referred to in paragraphs 195(1)(a) or (b) exists.

Effect of cancellation

(2) The following rules apply when the registration number of a test kit is cancelled:

• (a) in the case of a test kit produced before a cancellation under paragraph (1)(a),
  • (i) the activities set out in section 198 remain authorized, and
  • (ii) the registration number must remain on the label of the test kit; and
• (b) in the case of a test kit produced either before or after a cancellation under paragraph (1)(b), the registration number must not be displayed on its label.

Authorized activities

198 (1) Any person, other than a person referred to in subsection (2), may possess, sell, provide, transport, send, deliver, import or export a test kit if the following conditions are met:

• (a) subject to subparagraph 197(2)(a)(i), the registration number of the test kit has not been cancelled under subsection 197(1);
• (b) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and
• (c) the test kit carries a label on which the following information appears:
  • (i) the registration number of the test kit, and
  • (ii) in the case of a test kit that is not subject to the labelling requirements set out in the Medical Devices Regulations,
    • (A) the name and municipal address of the person that produced the test kit or, if the test kit is produced in accordance with a custom order, of the other person for whom the test kit was produced, and
    • (B) its brand name.

Member of police force

(2) A person referred to in section 2 may possess a test kit.

Miscellaneous Provisions

Advertising

Restrictions

199 A person who advertises a controlled substance may only do so to a person who is not part of the general public and, in the case of a written advertisement, under the following conditions:

• (a) the advertisement appears in a document distributed to, or in a trade publication for,
  • (i) a licensed dealer, or
  • (ii) a pharmacist, pharmacy technician or practitioner; and
• (b) the advertisement contains, in a conspicuous place, a legible and intelligible statement that the substance is a controlled substance.

Notification of Application for Order of Restoration

Written notification

200 (1) For the purpose of subsection 24(1) of the Act, the prior notification of an application for an order of restoration given to the Attorney General must be made in writing and provided by registered mail at least 15 days before the date on which the application is to be made to a justice.

Content of notification

(2) The prior notification must specify

• (a) the name of the justice to whom the application is to be made;
• (b) the time and place at which the application is to be heard;
• (c) details concerning the controlled substance or other thing in respect of which the application is to be made; and
• (d) the evidence on which the applicant intends to rely to establish that they are entitled to possession of the controlled substance or other thing referred to in paragraph (c).

Repeals

201 Parts G and J of the Food and Drug Regulations ^{footnote 2} are repealed.

202 The Narcotic Control Regulations ^{footnote 3} are repealed.

203 The Regulations Exempting Certain Precursors and Controlled Substances from the Application of the Controlled Drugs and Substances Act ^{footnote 4} are repealed.

204 The Benzodiazepines and Other Targeted Substances Regulations ^{footnote 5} are repealed.

205 The New Classes of Practitioners Regulations ^{footnote 6} are repealed.

Coming into Force

Publication

206 These Regulations come into force on the 365th day after the day on which they are published in the Canada Gazette, Part II.

SCHEDULE 1

(Subsection 1(1), paragraphs 5(1)(a), 11(1)(f), 12(1)(c) and (i), 34(1)(d), 39(c), 42(1)(d), 47(c), 56(3)(d), 57(1)(d), 58(1)(d), 59(d), 61(d) and 68(1)(d), subparagraph 71(e)(ii), paragraphs 72(1)(g), 74(d), 75(d), 76(a), 77(a), 79(g), 80(d), 81(d), 82(a), 83(e), 84(1)(a), 91(3)(d), 92(1)(d) and (2)(d), 93(1)(d), 94(d), 96(d), 109(d), 110(2)(d), 113(d), 116(g), 117(f), 124(d), 125(d), 136(c), 137(d), 138(2)(e) and 139(c), subparagraph 139(f)(ii), paragraphs 141(f), 142(f), 149(a) and 154(d), subparagraphs 155(1)(b)(iv), 156(1)(b)(iv) and 157(b)(iv), paragraphs 158(d), 169(d), 170(d), 171(d), 174(d), 175(g) and 176(f), sections 189 and 190 and paragraph 193(1)(c))

Narcotics

Item	Name
1	Opium Poppy (Papaver somniferum), its preparations, derivatives, alkaloids and salts, including (1) Opium (2) Codeine (methylmorphine) (3) Morphine (7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol) (4) Thebaine (paramorphine) and the salts, derivatives and salts of derivatives of the substances set out in subitems (1) to (4), including (5) Acetorphine (acetyletorphine) (6) Acetyldihydrocodeine (4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol acetate) (7) Benzylmorphine (7,8-didehydro-4,5-epoxy-17-methyl-3-(phenylmethoxy) morphinan-6-ol) (8) Codoxime (dihydrocodeinone O-(carboxymethyl)oxime) (9) Desomorphine (dihydrodeoxymorphine) (10) Diacetylmorphine (heroin) (11) Dihydrocodeine (4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol) (12) Dihydromorphine (4,5-epoxy-17-methylmorphinan-3,6-diol) (13) Ethylmorphine (7,8-didehydro-4,5-epoxy-3-ethoxy-17-methylmorphinan-6-ol) (14) Etorphine (tetrahydro-7α-(1-hydroxy-1-methylbutyl)-6,14-endo-ethenooripavine) (15) Hydrocodone (dihydrocodeinone) (16) Hydromorphinol (dihydro-14-hydroxymorphine) (17) Hydromorphone (dihydromorphinone) (18) Methyldesorphine (Δ6-deoxy-6-methylmorphine) (19) Methyldihydromorphine (dihydro-6-methylmorphine) (20) Metopon (dihydromethylmorphinone) (21) Morphine-N-oxide (morphine oxide) (22) Myrophine (benzylmorphine myristate) (23) Nalorphine (N-allylnormorphine) (24) Nicocodine (6-nicotinylcodeine) (25) Nicomorphine (dinicotinylmorphine) (26) Norcodeine (N-desmethylcodeine) (27) Normorphine (N-desmethylmorphine) (28) Oxycodone (dihydrohydroxycodeinone) (29) Oxymorphone (dihydrohydroxymorphinone) (30) Pholcodine (3-[2-(4-morpholinyl)ethyl]morphine) (31) Thebacon (acetyldihydrocodeinone) but not including (32) Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts (33) Cyprenorphine (N-(cyclopropylmethyl)-6,7,8,14-tetrahydro-7α-(1-hydroxy-1-methylethyl)-6,14-endo-ethenonororipavine) and its salts (34) Nalmefene (17-(cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol) and its salts (35) Naloxone (4,5α-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one) and its salts (36) Naltrexone (17-(cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one) and its salts (37) Methylnaltrexone (17-(cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxy-17-methyl-6-oxomorphinanium) and its salts (38) Naloxegol (4,5α-epoxy-6α-(3,6,9,12,15,18,21-heptaoxadocos-1-yloxy)-17-(2-propenyl)morphinan-3,14-diol) and its salts (39) Narcotine (6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)-1(3H)-isobenzofuranone) and its salts (40) Papaverine (1-[(3,4-dimethoxyphenyl)methyl]-6, 7-dimethoxyisoquinoline) and its salts (41) Poppy seed
2	Coca (Erythroxylum), its preparations, derivatives, alkaloids and salts, including (1) Coca leaves (2) Cocaine (benzoylmethylecgonine) (3) Ecgonine (3-hydroxy-2-tropane carboxylic acid) but not including (4) 123I-ioflupane
3	Phenylpiperidines, their intermediates, salts, derivatives and analogues and salts of intermediates, derivatives and analogues, including (1) Allylprodine (3-allyl-1-methyl-4-phenyl-4-piperidinol propionate) (2) Alphameprodine (α-3-ethyl-1-methyl-4-phenyl-4-piperidinol propionate) (3) Alphaprodine (α-1,3-dimethyl-4-phenyl-4-piperidinol propionate) (4) Anileridine (ethyl 1-[2-(p-aminophenyl)ethyl]-4-phenylpiperidine-4-carboxylate) (5) Betameprodine (ß-3-ethyl-1-methyl-4-phenyl-4-piperidinol propionate) (6) Betaprodine (ß-1,3-dimethyl-4-phenyl-4-piperidinol propionate) (7) Benzethidine (ethyl 1-(2-benzyloxyethyl)-4-phenylpiperidine-4-carboxylate) (8) Diphenoxylate (ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate) (9) Difenoxin (1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate) (10) Etoxeridine (ethyl 1-[2-(2-hydroxyethoxy)ethyl]-4-phenylpiperidine-4-carboxylate) (11) Furethidine (ethyl 1-(2-tetrahydrofurfuryloxyethyl)-4-phenylpiperidine-4-carboxylate) (12) Hydroxypethidine (ethyl 4-(m-hydroxyphenyl)-1-methylpiperidine-4-carboxylate) (13) Ketobemidone (1-[4-(m-hydroxyphenyl)-1-methyl-4-piperidyl]-1-propanone) (14) Methylphenylisonipecotonitrile (4-cyano-1-methyl-4-phenylpiperidine) (15) Morpheridine (ethyl 1-(2-morpholinoethyl)-4-phenylpiperidine-4-carboxylate) (16) Norpethidine (ethyl 4-phenylpiperidine-4-carboxylate) (17) Pethidine (ethyl 1-methyl-4-phenylpiperidine-4-carboxylate) (18) Phenoperidine (ethyl 1-(3-hydroxy-3-phenylpropyl)-4-phenylpiperidine-4-carboxylate) (19) Piminodine (ethyl 1-[3-(phenylamino)propyl]-4-phenylpiperidine-4-carboxylate) (20) Properidine (isopropyl 1-methyl-4-phenylpiperidine-4- carboxylate) (21) Trimeperidine (1,2,5-trimethyl-4-phenyl-4-piperidinol propionate) (22) Pethidine Intermediate C (1-methyl- 4-phenylpiperidine-4-carboxylate) but not including (23) Carperidine (ethyl 1-(2-carbamylethyl)-4-phenylpiperidine-4-carboxylate) and its salts (24) Oxpheneridine (ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate) and its salts
4	Phenazepines, their salts, derivatives and salts of derivatives including (1) Proheptazine (hexahydro-1,3-dimethyl-4-phenyl-1H-azepin-4-ol propionate) but not including (2) Ethoheptazine (ethyl hexahydro-1-methyl-4-phenylazepine-4-carboxylate) and its salts (3) Metethoheptazine (ethyl hexahydro-1,3-dimethyl-4-phenylazepine-4-carboxylate) and its salts (4) Metheptazine (methylhexahydro-1,2-dimethyl-4-phenylazepine-4-carboxylate) and its salts
5	Amidones, their intermediates, salts, derivatives and salts of intermediates and derivatives, including (1) Dimethylaminodiphenylbutanonitrile (4-cyano-2-dimethylamino-4,4-diphenylbutane) (2) Dipipanone (4,4-diphenyl-6-piperidino-3-heptanone) (3) Isomethadone (6-dimethylamino-5-methyl-4,4-diphenyl-3-hexanone) (4) Methadone (6-dimethylamino-4,4-diphenyl-3-heptanone) (5) Normethadone (6-dimethylamino-4,4-diphenyl-3-hexanone) (6) Norpipanone (4,4-diphenyl-6-piperidino-3-hexanone) (7) Phenadoxone (6-morpholino-4,4-diphenyl-3-heptanone)
6	Methadols, their salts, derivatives and salts of derivatives, including (1) Acetylmethadol (6-dimethylamino-4,4-diphenyl-3-heptanol acetate) (2) Alphacetylmethadol (α-6-dimethylamino-4,4-diphenyl-3-heptanol acetate) (3) Alphamethadol (α-6-dimethylamino-4,4-diphenyl-3-heptanol) (4) Betacetylmethadol (ß-6-dimethylamino-4,4-diphenyl-3-heptanol acetate) (5) Betamethadol (ß-6-dimethylamino-4,4-diphenyl-3-heptanol) (6) Dimepheptanol (6-dimethylamino-4,4-diphenyl-3-heptanol) (7) Noracymethadol (α-6-methylamino-4,4-diphenyl-3-heptanol acetate)
7	Phenalkoxams, their salts, derivatives and salts of derivatives, including (1) Dimenoxadol (dimethylaminoethyl 1-ethoxy-1,1-diphenylacetate) (2) Dioxaphetyl butyrate (ethyl 2,2-diphenyl-4-morpholinobutyrate) (3) Dextropropoxyphene ([S-(R*,S*)]-α-[2-(dimethylamino)-1-methylethyl]-α-phenylbenzeneethanol, propanoate ester)
8	Thiambutenes, their salts, derivatives and salts of derivatives, including (1) Diethylthiambutene (N,N-diethyl-1-methyl-3,3-di-2-thienylallylamine) (2) Dimethylthiambutene (N,N,1-trimethyl-3,3-di-2-thienylallylamine) (3) Ethylmethylthiambutene (N-ethyl-N,1-dimethyl-3,3-di-2-thienylallylamine)
9	Moramides, their intermediates, salts, derivatives and salts of intermediates and derivatives, including (1) Dextromoramide (d-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine) (2) Diphenylmorpholinoisovaleric acid (2-methyl-3-morpholino-1,1-diphenylpropionic acid) (3) Levomoramide (l-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine) (4) Racemoramide (d,l-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine)
10	Morphinans, their salts, derivatives and salts of derivatives, including (1) Buprenorphine (17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol) (2) Drotebanol (6ß,14-dihydroxy-3,4-dimethoxy-17-methylmorphinan) (3) Levomethorphan (1-3-methoxy-17-methylmorphinan) (4) Levorphanol (1-3-hydroxy-17-methylmorphinan) (5) Levophenacylmorphan (1-3-hydroxy-17-phenacylmorphinan) (6) Norlevorphanol (1-3-hydroxymorphinan) (7) Phenomorphan (3-hydroxy-17-(2-phenylethyl)morphinan) (8) Racemethorphan (d,l-3-methoxy-17-methylmorphinan) (9) Racemorphan (d,l-3-hydroxy-N-methylmorphinan) but not including (10) Dextromethorphan (d-1,2,3,9,10,10a-hexahydro-6-methoxy-11-methyl-4H-10,4a-iminoethanophenanthren) and its salts (11) Dextrorphan (d-1,2,3,9,10,10a-hexahydro-11-methyl-4H-10,4a-iminoethanophenanthren-6-ol) and its salts (12) Levallorphan (l-11-allyl-1,2,3,9,10,10a-hexahydro-4H-10,4a-iminoethanophenanthren-6-ol) and its salts (13) Levargorphan (l-11-propargyl-1,2,3,9,10,10a-hexahydro-4H-10,4a-iminoethanophenanthren-6-ol) and its salts (14) Butorphanol (l-N-cyclobutylmethyl-3,14-dihydroxymorphinan) and its salts (15) Nalbuphine (N-cyclobutylmethyl-4,5-epoxymorphinan-3,6,14-triol) and its salts
11	Benzazocines, their salts, derivatives and salts of derivatives, including (1) Phenazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl- 3-phenethyl-2,6-methano-3-benzazocin-8-ol) (2) Metazocine (1,2,3,4,5,6-hexahydro-3,6,11-trimethyl-2,6-methano-3-benzazocin-8-ol) (3) Pentazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol) but not including (4) Cyclazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(cyclopropylmethyl)-2,6-methano-3-benzazocin-8-ol) and its salts
12	Ampromides, their salts, derivatives and salts of derivatives, including (1) Diampromide (N-[2-(methylphenethylamino)propyl]propionanilide) (2) Phenampromide (N-(1-methyl-2-piperidino)ethyl)propionanilide) (3) Propiram (N-(1-methyl-2-piperidinoethyl)-N-2-pyridylpropionamide)
13	Benzimidazoles, their salts, derivatives and salts of derivatives, including (1) Clonitazene (2-(p-chlorobenzyl)-1-diethylaminoethyl-5-nitrobenzimidazole) (2) Etonitazene (2-(p-ethoxybenzyl)-1-diethylaminoethyl-5-nitrobenzimidazole) (3) Bezitramide (1-(3-cyano-3,3-diphenylpropyl)-4-(2-oxo-3-propionyl-1-benzimidazolinyl)-piperidine)
14	Phencyclidine (1-(1-phenylcyclohexyl)piperidine), its salts, derivatives and analogues and salts of derivatives and analogues, including (1) Ketamine (2-(2-chlorophenyl)-2-(methylamino)cyclohexanone)
15	Fentanyls, their salts, derivatives and analogues and salts of derivatives and analogues, including (1) Acetyl-α-methylfentanyl (N-[1-(α-methylphenethyl)-4-piperidyl]acetanilide) (2) Alfentanil (N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl]-4-(methoxymethyl)-4-piperidyl]propionanilide) (3) Carfentanil (methyl 4-[(1-oxopropyl)phenylamino]-1-(2-phenethyl)-4-piperidinecarboxylate) (4) p-Fluorofentanyl (4′ fluoro-N-(1-phenethyl-4-piperidyl)propionanilide) (5) Fentanyl (N-(1-phenethyl-4-piperidyl)propionanilide) (6) ß-Hydroxyfentanyl (N-[1-(ß-hydroxyphenethyl)-4-piperidyl]propionanilide) (7) ß-Hydroxy-3-methylfentanyl (N-[1-(ß-hydroxyphenethyl)-3-methyl-4-piperidyl]propionanilide) (8) α-Methylfentanyl (N-[1-(α-methylphenethyl)-4-piperidyl]propionanilide) (9) α-Methylthiofentanyl (N-[1-[1-methyl-2-(2-thienyl)ethyl]-4-piperidyl]propionanilide) (10) 3-Methylfentanyl (N-(3-methyl-1-phenethyl-4-piperidyl)propionanilide) (11) 3-Methylthiofentanyl (N-[3-methyl-1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide) (12) Remifentanil (dimethyl 4-carboxy-4-(N-phenylpropionamido)-1-piperidinepropionate) (13) Sufentanil (N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide) (14) Thiofentanyl (N-[1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide) (15) 4-Anilino-N-phenethylpiperidine (ANPP) (N-phenyl-1-(2-phenylethyl)piperidine-4-amine), its derivatives and analogues and salts of derivatives and analogues
16	Tilidine (ethyl 2-(dimethylamino)-1-phenyl-3-cyclohexene-1-carboxylate), its salts, derivatives and salts of derivatives
17	Synthetic cannabinoid receptor type 1 agonists, their salts, derivatives, isomers and salts of derivatives and isomers, including those that fall within the following core chemical structure classes, with the exception of any substance that is identical to any phytocannabinoid and of ((3S)-2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl)-1-naphthalenyl-methanone (WIN 55,212-3) and its salts: (1) Any substance that has a 2-(cyclohexyl)phenol structure with substitution at the 1-position of the benzene ring by a hydroxy, ether or ester group and further substituted at the 5-position of the benzene ring, whether or not further substituted on the benzene ring to any extent, and substituted at the 3’-position of the cyclohexyl ring by an alkyl, carbonyl, hydroxyl, ether or ester, and whether or not further substituted on the cyclohexyl ring to any extent, including (i) Nabilone ((±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one) (ii) Parahexyl (3-hexyl-6,6,9-trimethyl-7,8,9,10-tetrahydro-6H-dibenzo[b,d]pyran-1-ol) (iii) 3-(1,2-dimethylheptyl)-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran-1-ol (DMHP) (iv) 5-(1,1-dimethylheptyl)-2-(5-hydroxy-2-(3-hydroxypropyl)cyclohexyl)phenol (CP 55,940) (v) 5-(1,1-dimethylheptyl)-2-(3-hydroxycyclohexyl)phenol (CP 47,497) (2) Any substance that has a 3-(1-naphthoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including (i) 1-pentyl-3-(1-naphthoyl)indole (JWH-018) (ii) 1-butyl-3-(1-naphthoyl)indole (JWH-073) (iii) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122) (iv) 1-hexyl-3-(1-naphthoyl)indole (JWH-019) (v) 1-(4-pentenyl)-3-(1-naphthoyl)indole (JWH-022) (vi) 1-butyl-3-(4-methoxy-1-naphthoyl)indole (JWH-080) (vii) 1-pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081) (viii) 1-(2-morpholin-4-ylethyl)-3-(1-naphthoyl)indole (JWH-200) (ix) 1-pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210) (x) 1-pentyl-3-(2-methoxy-1-naphthoyl)indole (JWH-267) (xi) 1-[(N-methylpiperidin-2-yl)methyl]-3-(1-naphthoyl)indole (AM-1220) (xii) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201) (xiii) 1-(5-fluoropentyl)-3-(4-methyl-1-naphthoyl)indole (MAM-2201) (xiv) 1-(5-fluoropentyl)-3-(4-ethyl-1-naphthoyl)indole (EAM-2201) (xv) ((3R)-2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl)-1-naphthalenyl-methanone (WIN 55,212-2) (3) Any substance that has a 3-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted on the pyrrole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including (i) 1-pentyl-5-(2-fluorophenyl)-3-(1-naphthoyl)pyrrole (JWH-307) (4) Any substance that has a 3-phenylacetylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including (i) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250) (ii) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251) (iii) 1-pentyl-3-(3-methoxyphenylacetyl)indole (JWH-302) (5) Any substance that has a 3-benzoylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including (i) 1-(1-methylpiperidin-2-ylmethyl)-3-(2-iodobenzoyl)indole (AM-2233) (6) Any substance that has a 3-methanone(cyclopropyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the cyclopropyl ring to any extent, including (i) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (UR-144) (ii) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (5F-UR-144) (iii) (1-(2-(4-morpholinyl)ethyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (A-796,260) (7) Any substance that has a quinolin-8-yl 1H-indole-3-carboxylate structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the quinolin-8-yl ring to any extent, including (i) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22) (ii) 1-(5-fluoropentyl)-8-quinolinyl ester-1H-indole-3-carboxylic acid (5F-PB-22) (8) Any substance that has a 3-carboxamideindazole structure with substitution at the nitrogen atom of the indazole ring, whether or not further substituted on the indazole ring to any extent and whether or not substituted at the carboxamide group to any extent, including (i) N-(adamantan-1-yl)-1-pentyl-1H-indazole-3-carboxamide (AKB48) (ii) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (5F-AKB48) (iii) N-(1-(aminocarbonyl)-2-methylpropyl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) (iv) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) (9) Any substance that has a 3-carboxamideindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted at the carboxamide group to any extent, including (i) N-(adamantan-1-yl)-1-fluoropentylindole-3-carboxamide (STS-135) (ii) N-(adamantan-1-yl)-1-pentylindole-3-carboxamide (APICA)
18	Tapentadol (3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol), its salts, derivatives and isomers and salts of derivatives and isomers
19	Piritramide (1-(3-cyano-3,3-diphenylpropyl)-4-(1-piperidino)piperidine-4-carboxylic acid amide), its salts, derivatives and salts of derivatives

SCHEDULE 2

(Subsection 1(1), section 3, paragraphs 5(1)(b), 11(1)(f), 12(1)(c) and (i), 34(1)(d), 39(c), 42(1)(d), 47(c), 56(3)(d), 57(1)(d), 58(1)(d), 59(d), 61(d) and 68(1)(d), subparagraph 71(e)(ii), paragraphs 72(1)(g), 74(d), 75(d), 76(a), 77(a), 79(g), 80(d), 81(d), 82(a), 83(e), 84(1)(a), 91(3)(d), 92(1)(d) and (2)(d), 93(1)(d), 94(d), 96(d), 109(d), 110(2)(d), 113(d), 116(g), 117(f), 124(d), 125(d), 136(c), 137(d), 138(2)(e) and 139(c), subparagraph 139(f)(ii), paragraphs 141(f), 142(f), 149(b) and 154(d), subparagraphs 155(1)(b)(iv), 156(1)(b)(iv) and 157(b)(iv), paragraphs 158(d), 169(d), 170(d), 171(d), 174(d), 175(g) and 176(f), sections 189 and 190 and paragraph 193(1)(c))

Controlled Drugs

PART 1

Item	Name
1	Amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, excluding those substances set out in item 1 of Part 1 of Schedule 4 but including (1) Amphetamine (α-methylbenzeneethanamine) (2) Methamphetamine (N,α-dimethylbenzeneethanamine) (3) Benzphetamine (N-benzyl-N,α-dimethylbenzeneethanamine)
2	Methylphenidate (methyl 2-phenyl-2-(piperidin-2-yl)acetate), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including (1) Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate) (2) Isopropylphenidate (isopropyl 2-phenyl-2-(piperidin-2-yl)acetate) (3) Propylphenidate (propyl 2-phenyl-2-(piperidin-2-yl)acetate) (4) 3,4-Dichloromethylphenidate (methyl 2-(3,4-dichlorophenyl)-2-(piperidin-2-yl)acetate) (5) 4-Methylmethylphenidate (methyl 2-(4-methylphenyl)-2-(piperidin-2-yl)acetate) (6) 4-Fluoromethylphenidate (methyl 2-(4-fluorophenyl)-2-(piperidin-2-yl)acetate) (7) Methylnaphthidate (methyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate) (8) Ethylnaphthidate (ethyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate)
3	Methaqualone (2-methyl-3-(2-methylphenyl)-4(3H)-quinazolinone) and any of its salts
4	Phendimetrazine (d-3,4-dimethyl-2-phenylmorpholine) and any of its salts
5	Phenmetrazine (3-methyl-2-phenylmorpholine) and any of its salts
6	Pentobarbital (5-ethyl-5-(1-methylbutyl)barbituric acid)
7	Secobarbital (5-allyl-5-(1-methylbutyl)barbituric acid)
8	4-hydroxybutanoic acid (GHB) and any of its salts
9	Aminorex (5-phenyl-4,5-dihydro-1,3-oxazol-2-amine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including (1) 4-Methylaminorex (4-methyl-5-phenyl-4,5-dihydro-1,3-oxazol-2-amine) (2) 4,4’-Dimethylaminorex (4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine)
10	Fenetylline (d,l-3,7-dihydro-1,3-dimethyl-7-(2-[(1-methyl-2-phenethyl)amino]ethyl)-1H-purine-2,6-dione) and any salt thereof
11	Glutethimide (2-ethyl-2-phenylglutarimide)
12	Lefetamine ((-)-N,N-dimethyl-α-phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers
13	Mecloqualone (2-methyl-3-(2-chlorophenyl)-4(3H)-quinazolinone) and any of its salts
14	Mesocarb (3-(α-methylphenethyl)-N-(phenylcarbamoyl)sydnone imine) and any of its salts
15	Pemoline (2-amino-5-phenyl-oxazolin-4-one) and any of its salts
16	Zipeprol (4-(2-methoxy-2-phenylethyl)-α-(methoxyphenylmethyl)-1-piperazineethanol) and any of its salts
17	Amineptine (7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid) and any of its salts

PART 2

Item	Name
1	Barbiturates, their salts and derivatives, excluding the substances set out in items 6 and 7 of Part 1 as well as barbituric acid (2,4,6(1H,3H,5H)-pyrimidinetrione) and its salts and 1,3-dimethylbarbituric acid (1,3-dimethyl-2,4,6(1H,3H,5H)-pyrimidinetrione) and its salts, but including (1) Allobarbital (5,5-diallylbarbituric acid) (2) Alphenal (5-allyl-5-phenylbarbituric acid) (3) Amobarbital (5-ethyl-5-(3-methylbutyl)barbituric acid) (4) Aprobarbital (5-allyl-5-isopropylbarbituric acid) (5) Barbital (5,5-diethylbarbituric acid) (6) Butabarbital (5-sec-butyl-5-ethylbarbituric acid) (7) Butalbital (5-allyl-5-isobutylbarbituric acid) (8) Butallylonal (5-(2-bromoallyl)-5-sec-butylbarbituric acid) (9) Butethal (5-butyl-5-ethylbarbituric acid) (10) Cyclobarbital (5-(1-cyclohexen-1-yl)-5-ethylbarbituric acid) (11) Cyclopal (5-allyl-5-(2-cyclopenten-1-yl)barbituric acid) (12) Heptabarbital (5-(1-cyclohepten-1-yl)-5-ethylbarbituric acid) (13) Hexethal (5-ethyl-5-hexylbarbituric acid) (14) Hexobarbital (5-(1-cyclohexen-1-yl)-1,5-dimethylbarbituric acid) (15) Mephobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid) (16) Methabarbital (5,5-diethyl-1-methylbarbituric acid) (17) Methylphenobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid) (18) Propallylonal (5-(2-bromoallyl)-5-isopropyl-barbituric acid) (19) Phenobarbital (5-ethyl-5-phenylbarbituric acid) (20) Probarbital (5-ethyl-5-isopropylbarbituric acid) (21) Phenylmethylbarbituric Acid (5-methyl-5-phenylbarbituric acid) (22) Sigmodal (5-(2-bromoallyl)-5-(1-methylbutyl) barbituric acid) (23) Talbutal (5-allyl-5-sec-butylbarbituric acid) (24) Vinbarbital (5-ethyl-5-(1-methyl-1-butenyl)barbituric acid) (25) Vinylbital (5-(1-methylbutyl)-5-vinylbarbituric acid)
2	Thiobarbiturates, their salts and derivatives, including (1) Thialbarbital (5-allyl-5-(2-cyclohexen-1-yl)-2-thiobarbituric acid) (2) Thiamylal (5-allyl-5-(1-methylbutyl)-2-thiobarbituric acid) (3) Thiobarbituric Acid (2-thiobarbituric acid) (4) Thiopental (5-ethyl-5-(1-methylbutyl)-2- thiobarbituric acid)
3	Chlorphentermine (1-(p-chlorophenyl)-2-methyl-2-aminopropane) and any of its salts
4	Diethylpropion (2-(diethylamino)propiophenone) and any of its salts
5	Phentermine (α,α-dimethylbenzeneethanamine) and any of its salts
6	Butorphanol (l-N-cyclobutylmethyl-3,14-dihydroxymorphinan) and any of its salts
7	Nalbuphine (N-cyclobutylmethyl-4,5-epoxy-morphinan-3,6,14-triol) and any of its salts
8	Pyrovalerone (4′-methyl-2-(1-pyrrolidinyl)valerophenone) and any of its salts

PART 3

Item	Name
1	Anabolic steroids and their derivatives, including (1) Androisoxazole (17ß-hydroxy-17α-methylandrostano[3,2-c]isoxazole) (2) Androstanolone (17ß-hydroxy-5α-androstan-3-one) (3) Androstenediol (androst-5-ene-3ß,17ß-diol) (4) Bolandiol (estr-4-ene-3ß,17ß-diol) (5) Bolasterone (17ß-hydroxy-7α,17-dimethylandrost-4-en-3-one) (6) Bolazine (17ß-hydroxy-2α-methyl-5α-androstan-3-one azine) (7) Boldenone (17ß-hydroxyandrosta-1,4-dien-3-one) (8) Bolenol (19-nor-17α-pregn-5-en-17-ol) (9) Calusterone (17ß-hydroxy-7ß,17-dimethylandrost-4-en-3-one) (10) Clostebol (4-chloro-17ß-hydroxyandrost-4-en-3-one) (11) Drostanolone (17ß-hydroxy-2α-methyl-5α-androstan-3-one) (12) Enestebol (4,17ß-dihydroxy-17-methylandrosta-1,4-dien-3-one) (13) Epitiostanol (2α,3α-epithio-5α-androstan-17ß-ol) (14) Ethylestrenol (19-nor-17α-pregn-4-en-17-ol) (15) 4-Hydroxy-19-nor testosterone (16) Fluoxymesterone (9-fluoro-11ß,17ß-dihydroxy-17-methylandrost-4-en-3-one) (17) Formebolone (11α,17ß-dihydroxy-17-methyl-3-oxoandrosta-1,4-di-en-2-carboxaldehyde) (18) Furazabol (17-methyl-5α-androstano[2,3-c]furazan-17ß-ol) (19) Mebolazine (17ß-hydroxy-2α,17-dimethyl-5α-androstan-3-one azine) (20) Mesabolone (17ß-[(1-methoxycyclohexyl)oxy]-5α-androst-1-en-3-one) (21) Mesterolone (17ß-hydroxy-1α-methyl-5α-androstan-3-one) (22) Metandienone (17ß-hydroxy-17-methylandrosta-1,4-dien-3-one) (23) Metenolone (17ß-hydroxy-1-methyl-5α-androst-1-en-3-one) (24) Methandriol (17α-methylandrost-5-ene-3ß,17ß-diol) (25) Methyltestosterone (17ß-hydroxy-17-methylandrost-4-en-3-one) (26) Metribolone (17ß-hydroxy-17-methylestra-4,9,11-trien-3-one) (27) Mibolerone (17ß-hydroxy-7α,17-dimethylestr-4-en-3-one) (28) Nandrolone (17ß-hydroxyestr-4-en-3-one) (29) Norboletone (13-ethyl-17ß-hydroxy-18,19-dinorpregn-4-en-3-one) (30) Norclostebol (4-chloro-17ß-hydroxyestr-4-en-3-one) (31) Norethandrolone (17α-ethyl-17ß-hydroxyestr-4-en-3-one) (32) Oxabolone (4,17ß-dihydroxyestr-4-en-3-one) (33) Oxandrolone (17ß-hydroxy-17-methyl-2-oxa-5α-androstan-3-one) (34) Oxymesterone (4,17ß-dihydroxy-17-methylandrost-4-en-3-one) (35) Oxymetholone (17ß-hydroxy-2-(hydroxymethylene)-17-methyl-5α-androstan-3-one) (36) Prasterone (3ß-hydroxyandrost-5-en-17-one) (37) Quinbolone (17ß-(1-cyclopenten-1-yloxy)androsta-1,4-dien-3-one) (38) Stanozolol (17ß-hydroxy-17-methyl-5α-androstano[3,2-c]pyrazole) (39) Stenbolone (17ß-hydroxy-2-methyl-5α-androst-1-en-3-one) (40) Testosterone (17ß-hydroxyandrost-4-en-3-one) (41) Tibolone ((7α,17α)-17-hydroxy-7-methyl-19-norpregn-5(10)en-20-yn-3-one) (42) Tiomesterone (1α,7α-bis(acetylthio)-17ß-hydroxy-17-methylandrost-4-en-3-one) (43) Trenbolone (17ß-hydroxyestra-4,9,11-trien-3-one)
2	Zeranol (3,4,5,6,7,8,9,10,11,12-decahydro-7,14,16-trihydroxy-3-methyl-1H-2-benzoxacyclotetradecin-1-one)

SCHEDULE 3

(Subsection 1(1), paragraphs 5(1)(c), 11(1)(f), 12(1)(c) and (i), 34(1)(d), 39(c), 42(1)(d), 47(c), 56(3)(d), 57(1)(d), 58(1)(d), 59(d), 61(d) and 68(1)(d), subparagraph 71(e)(ii), paragraphs 72(1)(g), 74(d), 75(d), 76(a), 77(a), 79(g), 80(d), 81(d), 82(a), 83(e), 84(1)(a), 91(3)(d), 92(1)(d) and (2)(d), 93(1)(d), 94(d), 96(d), 109(d), 110(2)(d), 113(d), 116(g), 117(f), 124(d), 125(d), 136(c), 137(d), 138(2)(e) and 139(c), subparagraph 139(f)(ii), paragraphs 141(f), 142(f) and 154(d), subparagraphs 155(1)(b)(iv), 156(1)(b)(iv) and 157(b)(iv), paragraphs 158(d), 169(d), 170(d), 171(d), 174(d), 175(g) and 176(f), sections 189 and 190 and paragraph 193(1)(c))

Targeted Substances

PART 1

List of Class 1 Targeted Substances

Item	Name
1	Benzodiazepines, their salts and derivatives, including (1) Alprazolam (8-chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine) (2) Bromazepam (7-bromo-1,3-dihydro-5-(2-pyridyl)-2H-1,4-benzodiazepin-2-one) (3) Brotizolam (2-bromo-4-(o-chlorophenyl)-9-methyl-6H-thieno[3,2-f]-s-triazolo[4,3-a][1,4]diazepine) (4) Camazepam (7-chloro-1,3-dihydro-3-(N,N-dimethylcarbamoyl)-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one) (5) Chlordiazepoxide (7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide) (6) Clobazam (7-chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4(3H,5H)-dione) (7) Clonazepam (5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one) (8) Clorazepate (7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1H-1,4-benzodiazepine-3carboxylic acid) (9) Cloxazolam (10-chloro-11b-(o-chlorophenyl)-2,-3,7,11b-tetrahydrooxazolo [3,2-d][1,4]benzodiazepin-6[5H]-one) (10) Delorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-2H-1,-4-benzodiazepin-2-one) (11) Diazepam (7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one) (12) Estazolam (8-chloro-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine) (13) Ethyl Loflazepate (ethyl 7-chloro-5-(o-fluorophenyl)-2,3-dihydro-2-oxo-1H-1,4-benzodiazepine-3-carboxylate) (14) Fludiazepam (7-chloro-5-(o-fluorophenyl)-1,3-dihydro-1-methyl-2H-1,4-benzodiazepin-2-one) (15) Flurazepam (7-chloro-1-[2-(diethylamino)ethyl]-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one) (16) Halazepam (7-chloro-1,3-dihydro-5-phenyl-1(2,2,-2-trifluoroethyl)-2H-1,4-benzodiazepin2-one) (17) Haloxazolam (10-bromo-11b-(o-fluorophenyl)-2,3,7,11b-tetrahydrooxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one) (18) Ketazolam (11-chloro-8,12b-dihydro-2,8-dimethyl-12b-phenyl-4H-[1,3]-oxazino-[3,2-d][1,4]benzodiazepine-4,7(6H)-dione) (19) Loprazolam (6-(o-chlorophenyl)-2,4-dihydro-2-[(4-methyl-1-piperazinyl)methylene]-8-nitro-1H-imidazo[1,2-a][1,4]-benzodiazepin-1-one) (20) Lorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one) (21) Lormetazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-1-methyl-2H-1,4-benzodiazepin-2-one) (22) Medazepam (7-chloro-2,3-dihydro-1-methyl-5-phenyl-1H-1,4-benzodiazepine) (23) Midazolam (8-chloro-6-(o-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine) (24) Nimetazepam (1,3-dihydro-1-methyl-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one) (25) Nitrazepam (1,3-dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one) (26) Nordazepam (7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one) (27) Oxazepam (7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one) (28) Oxazolam (10-chloro-2,3,7,11b-tetrahydro-2-methyl-11b-phenyloxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one) (29) Pinazepam (7-chloro-1,3-dihydro-5-phenyl-1-(2-propynyl)-2H-1,4-benzodiazepin-2-one) (30) Prazepam (7-chloro-1-(cyclopropylmethyl)-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one) (31) Quazepam (7-chloro-5-(o-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-thione) (32) Temazepam (7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one) (33) Tetrazepam (7-chloro-5-(cyclohexen-1-yl)-1,3-dihydro-1-methyl-2H-1,4-benzodiazepin-2-one) (34) Triazolam (8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-a][1,4]benzodiazepine) but not including (35) Clozapine (8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine) and any of its salts (36) Flunitrazepam (5-(o-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one) and any of its salts or derivatives (37) Olanzapine (2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine) and its salts (38) Clozapine N-oxide (8-chloro-11-(4-methyl-4-oxido-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine) and its salts
2	Clotiazepam (5-(o-chlorophenyl)-7-ethyl-1,3-dihydro-1-methyl-2H-thieno[2,3-e]-1,4-diazepin-2-one) and any of its salts
3	Ethchlorvynol (ethyl-2-chlorovinyl ethynyl carbinol)
4	Ethinamate (1-ethynylcyclohexanol carbamate)
5	Fencamfamin (d,l-N-ethyl-3-phenylbicyclo[2,2,1]heptan-2-amine) and any of its salts
6	Fenproporex (d,l-3-[(α-methylphenethyl)amino]propionitrile) and any of its salts
7	Mazindol (5-(p-chlorophenyl)-2,5-dihydro-3H-imidazo[2,1-a]isoindol-5-ol)
8	Mefenorex (d,l-N-(3-chloropropyl)-α-methylbenzeneethanamine) and any of its salts
9	Meprobamate (2-methyl-2-propyl-1,3-propanedioldicarbamate)
10	Methyprylon (3,3-diethyl-5-methyl-2,4-piperidinedione)
11	Pipradrol (α,α-diphenyl-2-piperidinemethanol) and any of its salts
12	Zolpidem (N,N,6-trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide) and any of its salts

PART 2

List of Class 2 Targeted Substances

Item	Name
1	Flunitrazepam (5-(o-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one) and any of its salts or derivatives

SCHEDULE 4

(Subsections 1(1) and 6(1) and (2), paragraphs 11(1)(f), 12(1)(c) and (i), 34(1)(d), 39(c), 42(1)(d), 47(c), 56(3)(d), 61(d) and 68(1)(d), subparagraph 71(e)(ii), paragraphs 72(1)(g), 74(d), 75(d), 76(a), 77(a), 79(g), 80(d), 81(d), 82(a), 83(e), 84(1)(a), 124(d), 125(d), 136(c), 137(d), 138(2)(e), 141(f) and 142(f), section 186, paragraph 193(1)(c) and item 1 of Part 1 of Schedule 2)

Restricted Drugs

PART 1

Item	Name
1	The following amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues: (1) N-ethylamphetamine (N-ethyl-α-methylbenzeneethanamine) (2) 4-methyl-2,5-dimethoxyamphetamine (STP) (2,5-dimethoxy-4,α-dimethylbenzeneethanamine) (3) 3,4-methylenedioxyamphetamine (MDA) (α-methyl-1,3-benzodioxole-5-ethanamine) (4) 2,5-dimethoxyamphetamine (2,5-dimethoxy-α-methylbenzeneethanamine) (5) 4-methoxyamphetamine (4-methoxy-α-methylbenzeneethanamine) (6) 2,4,5-trimethoxyamphetamine (2,4,5-trimethoxy-α-methylbenzeneethanamine) (7) N-methyl-3,4-methylenedioxyamphetamine (N,α-dimethyl-1,3-benzodioxole-5-ethanamine) (8) 4-ethoxy-2,5-dimethoxyamphetamine (4-ethoxy-2,5-dimethoxy-α-methylbenzeneethanamine) (9) 5-methoxy-3,4-methylenedioxyamphetamine (7-methoxy-α-methyl-1,3-benzodioxole-5-ethanamine) (10) N,N-dimethyl-3,4-methylenedioxyamphetamine (N,N,α-trimethyl-1,3-benzodioxole-5-ethanamine) (11) N-ethyl-3,4-methylenedioxyamphetamine (N-ethyl-α-methyl-1,3-benzodioxole-5-ethanamine) (12) 4-ethyl-2,5-dimethoxyamphetamine (DOET) (4-ethyl-2,5-dimethoxy-α-methylbenzeneethanamine) (13) 4-bromo-2,5-dimethoxyamphetamine (4-bromo-2,5-dimethoxy-α-methylbenzeneethanamine) (14) 4-chloro-2,5-dimethoxyamphetamine (4-chloro-2,5-dimethoxy-α-methylbenzeneethanamine) (15) 4-ethoxyamphetamine (4-ethoxy-α-methyl-benzeneethanamine) (16) N-Propyl-3,4-methylenedioxyamphetamine (α-methyl-N-propyl-1,3-benzodioxole-5-ethanamine) (17) N-hydroxy-3,4-methylenedioxyamphetamine (N-[α-methyl-3,4-(methylenedioxy)phenethyl]hydroxylamine) (18) 3,4,5-trimethoxyamphetamine (3,4,5-trimethoxy-α-methylbenzeneethanamine)
2	Lysergic acid diethylamide (LSD) (N,N-diethyllysergamide) and any of its salts
3	N,N-Diethyltryptamine (DET) (3-[(2-diethylamino)ethyl]indole) and any of its salts
4	N,N-Dimethyltryptamine (DMT) (3-[(2-dimethylamino)ethyl]indole) and any of its salts
5	N-Methyl-3-piperidyl benzilate (LBJ) (3-[(hydroxydiphenylacetyl)oxy]-1-methylpiperidine) and any of its salts
6	Harmaline (4,9-dihydro-7-methoxy-1-methyl-3H-pyrido(3,4-b)indole) and any of its salts
7	Harmalol (4,9-dihydro-1-methyl-3H-pyrido(3,4-b)indol-7-ol) and any of its salts
8	Psilocin (3-[2-(dimethylamino)ethyl]-4-hydroxyindole) and any of its salts
9	Psilocybin (3-[2-(dimethylamino)ethyl]-4-phosphoryloxyindole) and any of its salts
10	N-(1-phenylcyclohexyl)ethylamine (PCE) and any of its salts
11	1-[1-(2-Thienyl)cyclohexyl]piperidine (TCP) and any of its salts
12	1-Phenyl-N-propylcyclohexanamine and any of its salts
13	Mescaline (3,4,5-trimethoxybenzeneethanamine) and any of its salts, but not peyote (lophophora)
14	2-Methylamino-1-phenyl-1-propanone and any of its salts
15	1-[1-(Phenylmethyl)cyclohexyl]piperidine and any of its salts
16	1-[1-(4-Methylphenyl)cyclohexyl]piperidine and any of its salts
17	Etryptamine (3-(2-aminobutyl)indole) and any of its salts
18	Rolicyclidine (1-(1-phenylcyclohexyl)pyrrolidine) and any of its salts
19	Benzylpiperazine [BZP], namely 1-benzylpiperazine and its salts, isomers and salts of isomers
20	Trifluoromethylphenylpiperazine [TFMPP], namely 1-(3-trifluoromethylphenyl)piperazine and its salts, isomers and salts of isomers
21	Methylenedioxypyrovalerone (MDPV), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues
22	Cathinone ((-)-α-aminopropiophenone) and its salts
23	2C-phenethylamines and their salts, derivatives, isomers and salts of derivatives and isomers that correspond to the following chemical description: any substance that has a 1-amino-2-phenylethane structure substituted at the 2′ and 5′ or 2′ and 6′ positions of the benzene ring by an alkoxy or haloalkoxy group, or substituted at two adjacent carbon atoms of the benzene ring which results in the formation of a furan, dihydrofuran, pyran, dihydropyran or methylenedioxy group — whether or not further substituted on the benzene ring to any extent, whether or not substituted at the amino group by one or two, or a combination of, methyl, ethyl, propyl, isopropyl, hydroxyl, benzyl (or benzyl substituted to any extent) or benzylene (or benzylene substituted to any extent) groups and whether or not substituted at the 2-ethyl (beta carbon) position by a hydroxyl, oxo or alkoxy group — and its salts and derivatives and salts of derivatives, including (1) 4-bromo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25B-NBOMe) (2) 4-chloro-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25C-NBOMe) (3) 4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25I-NBOMe) (4) 4-bromo-2,5-dimethoxybenzeneethanamine (2C-B)
24	AH-7921 (1-(3,4-dichlorobenzamidomethyl)cyclohexyldimethylamine), its salts, isomers and salts of isomers
25	MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including (1) Diphenidine (DEP) (1-(1,2-diphenylethyl)piperidine) (2) Methoxphenidine (2-MeO-Diphenidine, MXP) (1-[1-(2-methoxyphenyl)-2-phenylethyl]piperidine) (3) Ephenidine (NEDPA, EPE) (N-ethyl-1,2-diphenylethylamine) (4) Isophenidine (NPDPA) (N-isopropyl-1,2-diphenylethylamine) but not including (5) Lefetamine ((-)-N,N-dimethyl-α-phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers
26	W-18 (4-chloro-N-[1-[2-(4-nitrophenyl)ethyl]-2-piperidinylidene]benzenesulfonamide), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues
27	U-47700 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including (1) Bromadoline (4-bromo-N-(2-(dimethylamino)cyclohexyl)benzamide) (2) U-47109 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)benzamide) (3) U-48520 (4-chloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide) (4) U-50211 (N-(2-(dimethylamino)cyclohexyl)-4-hydroxy-N-methylbenzamide) (5) U-77891 (3,4-dibromo-N-methyl-N-(1-methyl-1-azaspiro[4.5]decan-6-yl)benzamide)

PART 2

Item	Name
1	Salvia divinorum (S. divinorum), its preparations and derivatives, including (1) Salvinorin A ((2S,4aR,6aR,7R,9S,10aS,10bR)-9-(acetyloxy)-2-(3-furanyl)dodecahydro-6a,10b-dimethyl-4,10-dioxo-2H-naphtho[2,1-c]pyran-7-carboxylic acid methyl ester)
2	Catha edulis Forsk, its preparations, derivatives, alkaloids and salts, including (1) Cathine (d-threo-2-amino-1-hydroxy-1-phenylpropane) but not including (2) Cathinone ((-)-α-aminopropiophenone) and its salts

PART 3

Item	Column 1 Substance	Column 2 Period

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