Canada Gazette, Part I, Volume 146, Number 51: Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations)
December 22, 2012
Statutory authorities
Food and Drugs Act, Controlled Drugs and Substances Act, Financial Administration Act and Patent Act
Sponsoring department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Background
Schedule F to the Food and Drug Regulations lists medicinal ingredients that are required to be sold pursuant to a prescription when sold as a drug in Canada. Currently, adding or removing medicinal ingredients to Schedule F requires approval from the Governor in Council following a well-established scientific review process.
Amendments to the Food and Drug Regulations are required to bring into force recent updates to the Food and Drugs Act that were introduced as part of Bill C-38 (Jobs, Growth and Long-term Prosperity Act) that received Royal Assent on June 29, 2012. More specifically, the Jobs, Growth and Long-term Prosperity Act gives the Minister of Health the power to establish a list that sets out prescription drugs or classes of prescription drugs and to provide that the list may be incorporated by reference. This process would continue to respect the scientific review process, but eliminate the need for the approval of the Governor in Council to amend the list of prescription drugs.
Issues and objectives
Regulatory amendments are needed to operationalize the amendments to the Food and Drugs Act that are intended to replace Schedule F with a list of prescription drugs that is to be incorporated by reference through regulation.
The objective of the amendments is to bring greater efficiency to the process of adding or removing drugs from a schedule maintained in regulations without compromising the well-established scientific review and consultation process.
Description
The proposed Regulations would repeal Schedule F and incorporate the Prescription Drug List (PDL) that is to be established by the Minister in accordance with the enabling amendments to the Food and Drugs Act. They would also provide the scientific criteria the Minister must consider in maintaining the PDL. The proposed overarching scientific criteria would support the existing Schedule F criteria and ensure that the scientific basis for assigning prescription status remains the same. Further to these primary changes, a number of consequential amendments and updates to current provisions relating to prescription drugs would be made.
As requested by pharmacists and their regulatory associations, amendments recognizing the right of pharmacy technicians to transfer prescriptions would also be made to reflect more modern provincial legislation and practice.
New provisions would be introduced to Part C, Division 1, of the Food and Drug Regulations to do the following:
- Define prescription drug. This would ensure that the prohibitions relating to the sale, import, and advertising of prescription drugs continue to apply to drugs with prescription status. Previously such drugs would have been subject to those prohibitions because they contained substances listed on Schedule F.
- Define the Prescription Drug List. This would be a Web-based list of drugs that the Minister is able to establish under the new section 29.1 of the Act. The PDL would include drugs or classes of drugs that have to be sold pursuant to a prescription from a licensed practitioner. This list would reproduce the list of drugs that are currently in Schedule F, with some minor modification for reasons of clarity.
- Establish scientific basis for listing. Three scientific criteria would be set out to determine whether a drug or class of drug should be sold pursuant to a prescription. These criteria would support the existing and publicly available Schedule F factors that would be re-stipulated in a guidance document. To add to the PDL, the Minister of Health shall consider whether any of the scientific criteria apply to a drug. To remove a drug or class from the PDL, the Minister shall consider the criteria and must determine that none of them apply to the drug or class.
- Allow for public consultation. The Minister would be required to consult the public on any proposal to remove a drug from the PDL for a period of time sufficient to allow comments from external stakeholders that would also meet international obligations under the World Trade Organization’s Agreement on Technical Barriers to Trade (TBT).
The following consequential amendments related to prescription drug status would also be made.
Food and Drug Regulations
The term “Schedule F” would be replaced with a reference to “prescription drug.” This would ensure that prohibitions for Schedule F continue to apply to drugs that are currently required to be sold pursuant to a prescription without interruption.
Precursor Control Regulations, Fees in Respect of Drugs and Medical Devices Regulations, Patented Medicines Regulations
Reference to “Schedule F” would be replaced with a reference to “prescription drug” or “Prescription Drug List” to ensure that these regulations continue to apply to drugs with prescription drug status.
Amendments related to the transfer of prescriptions by pharmacy technicians
Amendments would be made to indicate that both pharmacists and pharmacy technicians can transfer a prescription. The current record-keeping process surrounding this activity would also be made the responsibility of pharmacy technicians. A definition of pharmacy technician would also be provided.
“One-for-One” Rule
The “One-for-One” Rule applies to the proposed amendments of the Food and Drugs Regulations, in particular the provisions that allow the transfer of prescriptions by pharmacy technicians, currently being administrated solely by pharmacists. The inclusion of pharmacy technicians would be consistent with the intent of existing and proposed provincial regulations to better utilize the skill set of various health care professionals and reduce the administrative burden on the health care system. The proposal is considered an “out” under the rule as it reduces the operating and administrative costs of business, specifically community pharmacies and retailers that dispense prescriptions. The reduction is based on the salary differentials between pharmacists and regulated pharmacy technicians and the amount of time spent on the activities for transferring prescriptions.
The calculation assumes that the proposal would only have an initial effect starting in 2013 in three provinces — Alberta, British Columbia and Ontario — as they are the only provinces that have regulations for pharmacy technicians to date. Through the course of consultation, input will be sought on the intention of other provinces to follow suit.
The full impact of the proposal is assumed to occur after 2018, when all other provinces are expected to follow suit in regulating pharmacy technicians. The number of pharmacists in Canada is assumed to remain constant over 10 years.
From the Regulatory Cost Calculator and as supplemented with supporting analysis, the reduction in administrative burden is conservatively estimated to have an annualized “out” value of $8.7M and total present value of $60M over 10 years.
It should be noted that the benefit of the earlier relief of GST/HST charges mentioned below is not part of the consideration under the “One-for-One” Rule (it is classified as a financial burden relief), nor is the reduction in the administrative burden of hospitals accounted for since not-for-profit entities are excluded from the “One-for-One” Rule.
Small business lens
The small business lens does not apply to this proposal, as it would not impose costs on small business.
Consultation
Following the Royal Assent of Bill C-38, Health Canada met with or held teleconferences with key stakeholders to discuss the repeal of Schedule F and proposed overarching scientific criteria for listing on the PDL. Key participants in the consultation included human/veterinary innovative and generic drug manufacturers; retail pharmacy associations and their regulatory authorities; federal, provincial/territorial payers; health care providers and their associations; and animal health care associations.
The expected increase in efficiency was well received by the stakeholders, who reiterated previous comments received during technical consultations held in winter 2010–2011.
The proposal to condense the existing Schedule F criteria under three overarching scientific criteria was generally well supported with the understanding that adding or removing the prescription status of a drug will continue to be done on the existing scientific basis. Several stakeholders recommended that the existing schedule F criteria currently maintained in a guidance document be shifted into the Regulations as the proposed overarching criteria were too broad. One stakeholder expressed the need to ensure that the scientific basis on which to assign prescription status take into consideration the differences between veterinary and human use. As a result, the scientific basis for listing drugs as prescription includes more explicit consideration for veterinary use.
Through their national association (National Association of Pharmacy Regulatory Authorities), Canadian pharmacy operators have requested that Health Canada update the Food and Drug Regulations in order to reflect the modern provincial authorities that allow the transfer of prescriptions by pharmacy technicians. Pharmacy associations and their regulatory authorities were further consulted on this proposal during the fall of 2012.
Rationale
The proposed changes to the Food and Drug Regulations are necessary to implement the amendments to the Food and Drugs Act which were introduced by the Jobs, Growth and Long-term Prosperity Act; other regulatory options were not considered.
Currently, the list of drugs that must be sold pursuant to a prescription is maintained in a regulatory table. The objective of the proposed changes is to gain efficiencies for Health Canada in the maintenance of this list through the ability of the Minister of Health to incorporate by reference a list of prescription drugs and move towards a less burdensome non-regulatory approach.
The industry would benefit from reduced uncertainties about the timing of product launches for non-prescription drugs. It would also benefit from being allowed an earlier relief from GST/HST charges under the Excise Tax Act for prescription drugs. GST/HST charges and associated costs are currently incurred by industry while it waits for Schedule F to undergo the regulatory process.
Canadian patients would benefit from earlier access to non-prescription drugs once the scientific review and public consultation are completed.
Canadians, provincial/private payers and federal government departments (e.g. Canada Border Services Agency, Canada Revenue Agency) that regularly use Schedule F would also benefit from having access to a plain language, up-to-date Web-based list of drugs with prescription status for both human and veterinary use.
Implementation, enforcement and service standards
Once the amendments are made, Health Canada would post the PDL on its Web site. Existing guidance documents would also be updated as required.
No additional funding is anticipated in the short or long terms. The Department of Health anticipates that it would realize a small cost/resource saving by eliminating those steps that currently apply solely to the process of amending the regulations. In addition, the need for those activities that are now conducted by the Department of Justice (legal and drafting services) would also be reduced.
Contact
Robyn Brake
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address Locator: 3105A
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Fax: 613-941-7104
Email: LRM_MLR_consultations@hc-sc.gc.ca
PROPOSED REGULATORY TEXT
Notice is given that the Governor in Council, pursuant to section 30 (see footnote a) of the Food and Drugs Act (see footnote b), subsection 55(1) of the Controlled Drugs and Substances Act (see footnote c), subsection 19(1) (see footnote d) of the Financial Administration Act (see footnote e) and section 101 (see footnote f) of the Patent Act (see footnote g), proposes to make the annexed Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations).
Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be addressed to Robyn Brake, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada, Address Locator: 3105A, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario K1A 0K9 (fax: 613-941-7104; email: LRM_MLR_consultations@hc-sc.gc.ca).
Ottawa, December 13, 2012
JURICA ČAPKUN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING CERTAIN REGULATIONS CONCERNING PRESCRIPTION DRUGS (REPEAL OF SCHEDULE F TO THE FOOD AND DRUG REGULATIONS)
FOOD AND DRUGS ACT
FOOD AND DRUG REGULATIONS
1. Section A.01.010 of the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:
- “prescription drug” means a drug that is set out in the Prescription Drug List as amended from time to time, or a drug that is part of a class of drugs that is set out in it; (drogue sur ordonnance)
- “Prescription Drug List” means the list established by the Minister under section 29.1 of the Act; (Liste des drogues sur ordonnance)
2. Paragraph A.01.066(b) of the Regulations is replaced by the following:
- (b) a prescription drug.
3. (1) The definition “practitioner” in subsection C.01.001(1) of the Regulations is replaced by the following:
“practitioner” means a person who
- (a) is entitled under the laws of a province to treat patients with a prescription drug, and
- (b) is practising their profession in that province; (praticien)
(2) Subsection C.01.001(1) of the Regulations is amended by adding the following in alphabetical order:
“pharmacist” means a person who
- (a) is registered or otherwise entitled under the laws of a province to practise pharmacy, and
- (b) is practising pharmacy in that province; (pharmacien)
4. Subparagraph C.01.004(1)(b)(i) of the Regulations is replaced by the following:
- (i) the symbol “Pr” in the case of a prescrip-tion drug, but the symbol “Pr” shall not appear on the label of any other drug,
5. Paragraph C.01.004(1.5)(a) of the Regulations is replaced by the following:
- (a) a prescription drug;
6. Section C.01.010 of the Regulations is replaced by the following:
C.01.010. If it is necessary to provide adequate directions for the safe use of a parenteral drug or prescription drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A to the Act, such diseases, disorders or abnormal physical state may be mentioned on the labels and inserts accompanying the drug and, in that respect, the drug is exempt from subsections 3(1) and (2) of the Act.
7. Paragraph C.01.028(2)(c) of the Regulations is replaced by the following:
- (c) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations.
8. Paragraph C.01.031.2(1)(a) of the Regulations is replaced by the following:
- (a) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations;
9. Section C.01.033 of the Regulations is replaced by the following:
C.01.033. Section C.01.032 does not apply to a corticosteroid drug that is sold by a pharmacist under a prescription.
10. The Regulations are amended by adding the following after section C.01.040.2:
Prescription Drugs
C.01.040.3 In deciding whether to amend the Prescription Drug List in respect of a drug, including by adding the drug to it or removing the drug from it, the Minister shall consider whether any of the following criteria apply with respect to the drug:
- (a) supervision by a practitioner is necessary
- (i) for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or
- (ii) to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug;
- (b) the level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner; or
- (c) use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner’s supervision.
C.01.040.4 The Minister shall consult the general public on any proposal by the Minister to remove a drug from the Prescription Drug List.
C.01.040.5 Sections C.01.040.3 and C.01.040.4 apply, with any modifications that the circumstances require, in respect of classes of drugs.
11. The heading before section C.01.041 and sections C.01.041 to C.01.046 of the Regulations are replaced by the following:
C.01.041. (1) No person shall sell a prescription drug unless
- (a) they are entitled under the laws of a province to dispense a prescription drug and they sell it in that province under a verbal or written prescription that they received; or
- (b) they sell it under section C.01.043.
(2) In the case of a verbal prescription, the person referred to in paragraph (1)(a) shall create a written record of the prescription that includes the following information:
- (a) the date on which the prescription was received and, if applicable, the number of the prescription;
- (b) the name and address of the person to whom the prescription was issued;
- (c) the proper name, common name or brand name of the drug and its quantity;
- (d) the person’s name and the name of the practitioner who issued the prescription; and
- (e) the directions for use provided with the prescription, whether or not the practitioner authorized it to be refilled and, if refills are authorized, the number of authorized refills.
(3) The person referred to in paragraph (1)(a) shall retain the written prescription referred to in subsection (1) or the record referred to in subsection (2) for at least two years after the day on which the prescription is filled.
C.01.041.01 In sections C.01.041.1 to C.01.041.3 “pharmacy technician” means a person who
- (a) is registered or otherwise entitled under the laws of a province to practise as a pharmacy technician; and
- (b) is practising as a pharmacy technician in that province.
C.01.041.1 Subject to paragraph C.01.041.3(2)(b), a pharmacist or pharmacy technician may transfer to another pharmacist or pharmacy technician a prescription for a prescription drug.
C.01.041.2 (1) Before a pharmacist sells a drug under a prescription that was transferred under section C.01.041.1, the pharmacist shall
- (a) create a written record of the name and address of the pharmacist or pharmacy technician who transferred the prescription and, if applicable, the number of authorized refills remaining and the date of the last refill; and
- (b) obtain a copy of the written prescription or of the written record that was created under subsection C.01.041(2), as the case may be, or, in the case of a verbal transfer, create a written record that includes the information referred to in that subsection.
(2) The pharmacist shall retain the documents referred to in subsection (1) for at least two years after the day on which the prescription was filled.
C.01.041.3 (1) A pharmacist or a pharmacy technician who transfers a prescription under section C.01.041.1 shall indicate the date of transfer on the original of the written prescription or of the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be.
(2) When the pharmacist or pharmacy technician has transferred the prescription,
- (a) the pharmacist shall not make any additional sales under the prescription; and
- (b) the pharmacist or pharmacy technician shall not transfer the prescription to another pharmacist or pharmacy technician.
C.01.042. A person referred to in paragraph C.01.041(1)(a) shall not refill a prescription for a prescription drug unless authorized by the practitioner and, in the case of such an authorization, they shall not refill a prescription more than the number of times specified by the practitioner.
C.01.042.1 A person referred to in paragraph C.01.041(1)(a) shall indicate on the original of or on the copy of the written prescription or the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be,
- (a) the date on which the prescription was filled;
- (b) the date of each refill, if applicable;
- (c) the quantity of drug sold when the prescription was filled and, if applicable, for each refill; and
- (d) the name of the person who sold the drug.
C.01.043. (1) A person may sell a prescription drug to
- (a) a drug manufacturer;
- (b) a practitioner;
- (c) a wholesale druggist;
- (d) a pharmacist; or
- (e) the Government of Canada or the government of a province, for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative.
(2) If a person sells a prescription drug under paragraph (1)(e), they shall retain the written order for the drug for a period of at least two years after the day on which the drug is sold.
C.01.044. If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug.
C.01.045. No person, other than one of the following, shall import a prescription drug:
- (a) a practitioner;
- (b) a drug manufacturer;
- (c) a wholesale druggist;
- (d) a pharmacist; or
- (e) a resident of a foreign country.
12. Section C.01.434 of the Regulations is replaced by the following:
C.01.434. Section C.01.433 does not apply to chloramphenicol and its salts or derivatives that are sold by a pharmacist under a prescription.
13. Section C.01.625 of the Regulations is replaced by the following:
C.01.625. Contraceptive drugs that are manufactured, sold or represented for use in the prevention of conception and that are not prescription drugs may be advertised to the general public.
14. Paragraph (a) of the definition “wholesale” in subsection C.01A.001(1) of the Regulations is replaced by the following:
- (a) a drug listed in Schedule C or D to the Act, a drug that is a prescription drug, or a controlled drug as defined in subsection G.01.001(1); or
15. Paragraph C.01A.003(a) of the Regulations is replaced by the following:
- (a) a distributor of a drug listed in Schedule C or D to the Act, a drug that is a prescription drug, a controlled drug as defined in subsection G.01.001(1) or a narcotic as defined in the Narcotic Control Regulations, who does not hold the drug identification number for the drug or narcotic; and
| Item | Categories of Drugs |
|---|---|
| 6. | Drugs that are prescription drugs, controlled drugs as defined in subsection G.01.001(1) and narcotics as defined in the Narcotic Control Regulations |
17. Section C.03.015 of the Regulations is replaced by the following:
C.03.015. (1) Every package of a drug that is a prescription drug shall carry the symbol “Pr” on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label.
(2) Subsection (1) does not apply to
- (a) a drug sold to a drug fabricator;
- (b) a drug sold under a prescription;
- (c) a radiopharmaceutical as defined in section C.03.201; or
- (d) a component or kit as defined in section C.03.205.
18. Section C.04.020 of the Regulations is replaced by the following:
C.04.020. Except in the case of the following drugs, every package of a drug that is a prescription drug shall carry the symbol “Pr” on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label:
- (a) a drug sold to a person who holds an establishment licence; and
- (b) a drug sold under a prescription.
19. Schedule F to the Regulations is repealed.
CONTROLLED DRUGS AND SUBSTANCES ACT
PRECURSOR CONTROL REGULATIONS
20. Paragraph 2(a) of the Precursor Control Regulations (see footnote 2) is replaced by the following:
- (a) a Class A precursor that is a prescription drug as defined in section A.01.010 of the Food and Drug Regulations; or
FINANCIAL ADMINISTRATION ACT
FEES IN RESPECT OF DRUGS AND MEDICAL DEVICES REGULATIONS
21. Subsection 15(1) of the Fees in Respect of Drugs and Medical Devices Regulations (see footnote 3) is amended by adding the following in alphabetical order :
- “controlled drug”
« drogue contrôlée » - “controlled drug” has the same meaning as in subsection G.01.001(1) of the Food and Drug Regulations.
- “narcotic”
« stupéfiant » - “narcotic” has the same meaning as in section 2 of the Narcotic Control Regulations.
22. The definitions “controlled drug” and “narcotic” in section 29 of the Regulations are repealed.
| Item | Column 1 Submission Class |
Column 2 Description |
|---|---|---|
| 7. | Switch status from prescription drug to non-prescription drug | Submissions based only on data that support the amendment, or the removal, of the reference to the medicinal ingredient on the Prescription Drug List that is applicable to the drug in question. |
| Item | Column 1 Description |
|---|---|
| 3. | Drugs for human use that are prescription drugs, controlled drugs or narcotics |
PATENT ACT
PATENTED MEDICINES REGULATIONS
25. The definition “notice of compliance” in section 2 of the Patented Medicines Regulations (see footnote 4) is replaced by the following:
“notice of compliance” means a notice issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations. (avis de conformité)
26. (1) The portion of subsection 4(2) of the Regulations before paragraph (a) is replaced by the following:
(2) In the case of a medicine for human use that contains a controlled substance as defined in the Controlled Drugs and Substances Act or a substance listed or described in Schedule C or D to the Food and Drugs Act or that is a prescription drug as defined in section A.01.010 of the Food and Drug Regulations, the information referred to in subsection (1) shall be provided
(2) Subsection 4(3) of the Regulations is replaced by the following:
(3) In the case of a medicine for human use that does not contain a controlled substance as defined in the Controlled Drugs and Substances Act or a substance listed or described in Schedule C or D to the Food and Drugs Act or that is not a prescription drug as defined in section A.01.010 of the Food and Drug Regulations or in the case of a medicine for veterinary use, the information referred to in subsection (1), for each six-month period beginning on January 1 and July 1 of each year, shall be provided to the Board within 30 days after the day on which the Board sends a request in response to a complaint respecting the price of the medicine and, during the two years following the request, within 30 days after the end of each six-month period.
COMING INTO FORCE
27. These Regulations come into force six months after the day on which section 413 of the Jobs, Growth and Long-term Prosperity Act, chapter 19 of the Statutes of Canada, 2012, comes into force, but if they are registered after that day, they come into force six months after the day on which they are registered.
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