Vol. 147, No. 13 — June 19, 2013

Registration

SOR/2013-122 June 7, 2013

FOOD AND DRUGS ACT
CONTROLLED DRUGS AND SUBSTANCES ACT
FINANCIAL ADMINISTRATION ACT
PATENT ACT

Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations)

P.C. 2013-648 June 6, 2013

His Excellency the Governor General in Council, on the recommendation of the Minister of Health with respect to sections 1 to 19, 24 and 25 of the annexed Regulations, and on the recommendation of the Treasury Board and the Minister of Health with respect to sections 20 to 23 and 26 of the annexed Regulations, makes the annexed Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations) pursuant to

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:

3. (1) The definition “practitioner” in subsection C.01.001(1) of the Regulations is replaced by the following:

“practitioner” means a person who

(2) Subsection C.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

“pharmacist” means a person who

“pharmacy technician” means a person who

4. Subparagraph C.01.004(1)(b)(i) of the Regulations is replaced by the following:

5. Paragraph C.01.004(1.5)(a) of the Regulations is replaced by the following:

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:

8. Paragraph C.01.031.2(1)(a) of the Regulations is replaced by the following:

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:

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

(2) In the case of a verbal prescription, the person referred to in paragraph (1)(a) or a pharmacy technician shall create a written record of the prescription that includes the following information:

(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.01.041.1 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 or a pharmacy technician shall

(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,

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,

C.01.043. (1) A person may sell a prescription drug to

(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:

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 “wholesaler” in subsection C.01A.001(1) of the Regulations is replaced by the following:

15. Item 6 of Table II to section C.01A.008 of the Regulations is replaced by the following:

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

16. 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

17. 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:

18. Schedule F to the Regulations is repealed.

CONTROLLED DRUGS AND SUBSTANCES ACT

PRECURSOR CONTROL REGULATIONS

19. Paragraph 2(a) of the Precursor Control Regulations (see footnote 2) is replaced by the following:

FINANCIAL ADMINISTRATION ACT

FEES IN RESPECT OF DRUGS AND MEDICAL DEVICES REGULATIONS

20. 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:

21. The definitions “controlled drug” and “narcotic” in section 29 of the Regulations are repealed.

22. The portion of item 7 of Schedule 1 to the Regulations in columns 1 and 2 is replaced by the following:

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.

23. The portion of item 3 of Schedule 5 to the Regulations in column 1 is replaced by the following:

Item

Column 1
Description

3.

Drugs for human use that are prescription drugs, controlled drugs or narcotics

PATENT ACT

PATENTED MEDICINES REGULATIONS

24. 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)

25. (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

26. These Regulations come into force on the day that is 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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Background

Amendments to the Food and Drug Regulations were required to bring into force the updates to the Food and Drugs Act introduced as part of Bill C-38 (Jobs, Growth and Long-term Prosperity Act), which received Royal Assent on June 29, 2012. More specifically, the Jobs, Growth and Long-term Prosperity Act gave the Minister of Health the power to establish an administrative list that sets out prescription drugs or classes of prescription drugs and to enable this list to be incorporated by reference in regulation. Previously, medicinal ingredients that required a prescription when sold as a drug in Canada were listed in Schedule F to the Food and Drug Regulations. Adding or removing medicinal ingredients to Schedule F required approval from the Governor in Council following a well-established scientific review process. This new process continues to respect the scientific review process, while eliminating the need for approval of the Governor in Council to amend the list of prescription drugs.

Issues and objectives

These amendments to the Food and Drug Regulations bring about the amendments to the Food and Drugs Act that replace Schedule F with an administrative list of prescription drugs. This list is incorporated by reference through regulation.

The amendments 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 Regulations repeal Schedule F and incorporate the Prescription Drug List (PDL) to be established by the Minister in accordance with the enabling amendments to the Food and Drugs Act. They also provide the scientific criteria the Minister must consider in maintaining the PDL. Overarching scientific criteria ensure that the 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 are also made.

As requested by pharmacists and their regulatory associations, amendments recognizing the right of pharmacy technicians to transfer prescriptions are also made to reflect more modern provincial legislation and practice.

New provisions are introduced to Part C, Division 1, of the Food and Drug Regulations to do the following:

The following consequential amendments related to prescription drug status are also made.

Food and Drug Regulations

The term “Schedule F” is replaced with a reference to “prescription drug.” This will 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” is replaced with a reference to “prescription drug” or “Prescription Drug List” to ensure that these regulations apply to drugs with prescription drug status.

Amendments related to the transfer of prescriptions by pharmacy technicians

Amendments are made to indicate that both pharmacists and pharmacy technicians can transfer a prescription. The current record-keeping process surrounding this activity may also be undertaken by pharmacy technicians. A definition of pharmacy technician is provided.

“One-for-One” Rule

The “One-for-One” Rule applies to the amendments of the Food and Drug Regulations, in particular the provision that allows the transfer of prescriptions by pharmacy technicians, currently being administrated solely by pharmacists. The inclusion of pharmacy technicians is consistent with the intent of existing and proposed provincial regulations to better utilize the skill set of various health care professionals and to reduce the administrative burden on the health care system. The provision 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 provision will 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. The provinces of Nova Scotia, New Brunswick, Manitoba, Saskatchewan, and Prince Edward Island have indicated that they expect to have regulations in place for pharmacy technicians prior to 2018. The full impact of the proposal is assumed to occur after 2018, when the Province of Newfoundland and Labrador is anticipated to regulate pharmacy technicians. The table below provides the statistics on the number of community pharmacists practising in various provinces as of January 1, 2013.

Jurisdiction

Pharmacists Practising in Community

Alberta

N/A (see footnote 5)

British Columbia

3 372

Manitoba

1 003

New Brunswick

617

Newfoundland and Labrador

500

Nova Scotia

978

Ontario

8 770

Prince Edward Island

135

Saskatchewan

998

Source: National Association of Pharmacy Regulatory Authorities (NAPRA).

The number of pharmacists in Canada is assumed to grow at 2% per year over 10 years.

From the Regulatory Cost Calculator and as supplemented with supporting analysis, the reduction in administrative burden is estimated to have an annualized “OUT” value of $15M and total present value of $105.8M over 10 years, based on information from the survey conducted by a key stakeholder. It should be noted that the benefit of the earlier relief of Goods and Services Tax /Harmonized Sales Tax (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 does not impose costs on small business.

Consultation

Development of regulatory process

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 using the existing scientific criteria. 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 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.

Comments received following publication of the Regulations in the Canada Gazette, Part I

Following publication in Canada Gazette, Part I, on December 22, 2012, nine stakeholders submitted their comments during the 75-day comment period. Six stakeholders supported replacing what they consider to be an inefficient and resource-consuming regulatory process, provided that the well-established scientific review and consultation process is maintained. The remaining three stakeholders supported expediting the scheduling process but had some reservations regarding some of the details in the regulatory package.

The comments received and Health Canada’s responses to them are summarized below.

Prescription Drug List

Two stakeholders commented that the proposed name “Prescription Drug List” is not appropriate, as controlled substances are also sold under prescription. Health Canada will add a clarification in the PDL to indicate that substances currently found on Controlled Drugs and Substances Act schedules are not included in this list.

Four stakeholders requested clarity on how the new PDL would distinguish drugs for human and veterinary use, including non-prescription drugs. In response, the PDL will be divided into human drug and veterinary drug categories. Non-prescription human and veterinary products can be located in searchable form on Health Canada’s Web site.

One stakeholder identified two substances that were previously included in the Regulations, and inquired about their status with regard to the PDL. Health Canada confirms that these substances have been removed from the Regulations and are included in the PDL.

Definition of prescription drug

Two stakeholders, while generally supporting the definition of “prescription drug,” were concerned that classes of drugs in the listing are not well defined and need to be consulted on prior to their establishment. In response, the current Schedule F contains medicinal substances that are listed as either individual substances or classes of drugs (e.g. penicillins and prostaglandins). This approach will be maintained in the new Prescription Drug List. In addition, any changes that involve drug class will be consulted upon prior to implementation.

Scientific basis for listing

Four stakeholders were supportive of the three proposed scientific criteria to determine the prescription status for a drug.

Health Canada has considered each of the comments. The suggestion to qualify “harm” with “significant” will not alter the interpretation of “harm” and will be maintained.

Allowance for public consultation

One stakeholder supported the proposal that the consultation process should be used only for removals from the PDL. In contrast, one stakeholder was concerned that the consultation process will be limited to removals. Another stakeholder asked whether consultation input would be considered in the removal of a substance from the list. Finally, two stakeholders would like to see more detail on the consultation and notification processes.

Health Canada responds that the vast majority of input received in previous consultations was for removals of medicinal substances from Schedule F. Health Canada has always considered these comments when removing substances from the Schedule and intends to continue this practice with the implementation of the PDL. Greater details of the notification and consultation processes are posted to Health Canada’s Web site.

Pharmacy technicians

Two stakeholders support the change to allow transfer of prescriptions by pharmacy technicians. However, both stakeholders expressed concerns that the proposed changes to the Regulations may inadvertently prevent pharmacy technicians from being allowed to transcribe verbal orders. Health Canada agrees with these concerns and has modified the proposed language to continue to allow pharmacy technicians to transcribe verbal orders. Further clarification is also made in subsection C.01.041.2(1) with respect to the identified issue.

Coming into force

Three stakeholders provided comments on the coming into force of the Regulations. One stakeholder requested advance notification of this action, as their own legislation requires amendments resulting from the proposed changes. Two other stakeholders asked that the proposed transition time be extended. One specified a period of 12 months to allow for legislative amendments to their own regulations and changes to operational procedures. In response, Health Canada’s proposed 6-month delay of the coming into force along with the earlier pre-consultation and consultation was intended to allow appropriate notice and time to make the necessary changes.

Miscellaneous

One stakeholder suggested that deletion of “while a visitor in Canada” in paragraph C.01.045(e) in the proposal would modify the policy intent on personal importation. In response, Health Canada has reinserted the proposed deletion back into paragraph C.01.045(e) in order to clarify that the policy intent has not changed and a resident of a foreign country is importing a drug for their own use while a visitor in Canada.

One stakeholder was concerned that printed copies of verbal orders would not be accepted as written records. Health Canada confirms that “written” and “printed” are interpreted as being equivalent.

One stakeholder asked for clarity regarding the signature requirements for written prescriptions. Health Canada considers this concern to be outside of the scope of this regulatory amendment.

Rationale

Changes to the Food and Drug Regulations were necessary to implement the amendments to the Food and Drugs Act that were introduced by the Jobs, Growth and Long-term Prosperity Act; other regulatory options were not considered.

Previously, the list of drugs required to be sold pursuant to a prescription was maintained in a regulatory table (i.e. Schedule F). The regulatory changes enable the Minister of Health to incorporate by reference a list of prescription drugs and to maintain the list administratively; this creates operational efficiencies for Health Canada through a more efficient, non-regulatory approach.

With these changes, the industry benefits from reduced uncertainties about the timing of product launches for non-prescription drugs. It also benefits from being allowed an earlier relief from GST/HST charges under the Excise Tax Act for prescription drugs. Charges relating to the GST/HST and associated costs were previously incurred by industry while it waited for Schedule F to undergo the regulatory process.

Canadian patients will benefit from earlier access to nonprescription 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 had regularly used Schedule F 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

In addition to these amendments, Health Canada has posted the PDL on its Web site and updated all associated guidance documents.

Contact

Brian Fuerst
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@hc-sc.gc.ca