ARCHIVED — Vol. 147, No. 22 — October 23, 2013

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Registration

SOR/2013-172 October 2, 2013

CONTROLLED DRUGS AND SUBSTANCES ACT FOOD AND DRUGS ACT

Regulations Amending Certain Regulations Relating to Access to Restricted Drugs

P.C. 2013-1049 October 2, 2013

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Regulations Relating to Access to Restricted Drugs pursuant to

REGULATIONS AMENDING CERTAIN REGULATIONS RELATING TO ACCESS TO RESTRICTED DRUGS

CONTROLLED DRUGS AND SUBSTANCES ACT

FOOD AND DRUG REGULATIONS

1. (1) The definition “restricted drug” in section J.01.001 of the Food and Drug Regulations (see footnote 1) is replaced by the following:

“restricted drug” means

  • (a) any substance that is set out in the schedule to this Part or anything that contains the substance; and
  • (b) cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, except a drug in dosage form, as defined in subsection C.01.005(3), that has a drug identification number assigned to it under Division 1 of Part C or that is authorized for sale under Division 5 of Part C, and except cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, that is to be or that has been compounded by a pharmacist in accordance with or in anticipation of a prescription; (drogue d’usage restreint)

(2) Section J.01.001 of the Regulations is amended by adding the following in alphabetical order:

“pharmacist” means a person who is registered or otherwise entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province; (pharmacien)

“prescription” means an authorization given by a practitioner, as defined in subsection 2(1) of the Act, that a stated amount of a drug be dispensed for the person named in the authorization; (ordonnance)

2. The schedule to Part J of the Regulations is amended by adding the following after item 22:

23. Diacetylmorphine (heroin) and its salts

NARCOTIC CONTROL REGULATIONS

3. (1) The definition “diacetylmorphine (heroin)” in section 2 of the Narcotic Control Regulations (see footnote 2) is repealed.

(2) The definition “pharmacist” in section 2 of the Regulations is replaced by the following:

“pharmacist” means

  • (a) a person who is registered or otherwise entitled under the laws of a province to practise pharmacy and to operate a pharmacy or dispensary and who
    • (i) is practising pharmacy in that province, and
    • (ii) is operating a pharmacy or dispensary in that province, and
  • (b) for the purpose of subsection 2(2), sections 3, 31 to 39, subsections 44(1), 45(1) and (2), section 46 and subsections 65(3) to (4), a person who is registered or otherwise entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province; (pharmacien)

(3) The portion of the definition “narcotic” in section 2 of the Regulations before paragraph (a) is replaced by the following:

“narcotic” means, subject to subsection (2),

(4) Paragraph (c) of the definition “verbal prescription narcotic” in section 2 of the Regulations is replaced by the following:

  • (c) does not contain hydrocodone, methadone, oxycodone or pentazocine. (stupéfiant d’ordonnance verbale)

(5) Section 2 of the Regulations is renumbered as subsection 2(1) and is amended by adding the following:

(2) Despite subitem 2(2) of the schedule, the following are not narcotics for the purposes of these Regulations:

  • (a) a drug in dosage form, as defined in subsection C.01.005(3) of the Food and Drug Regulations, that contains cocaine (benzoylmethylecgonine) or any of its salts unless the drug has a drug identification number assigned to it under Division 1 of Part C of those Regulations, is authorized for sale under Division 5 of Part C of those Regulations or has been compounded by a pharmacist in accordance with or in anticipation of an authorization from a practitioner that a stated amount of the drug be dispensed for a person who is or will be named in the authorization; or
  • (b) cocaine (benzoylmethylecgonine) or any of its salts, or any drug that is not in dosage form that contains such a substance, unless the cocaine, salt or drug is to be compounded by a pharmacist in accordance with or in anticipation of an authorization from a practitioner that a stated amount of the drug be dispensed for a person who is or will be named in the authorization.

4. The portion of paragraph 3(1)(d) of the Regulations before subparagraph (i) is replaced by the following:

  • (d) has obtained the narcotic for his own use

5. (1) The portion of subsection 24(2) of the Regulations before paragraph (a) is replaced by the following:

(2) Subject to subsection (2.2) and section 25, a licensed dealer may sell or provide any narcotic other than methadone to

(2) Subsection 24(4) of the Regulations is repealed.

6. Subparagraph 27(2)(a)(i) of the Regulations is replaced by the following:

  • (i) if the narcotic is to be sold or provided to a person referred to in paragraph 24(2)(a), (b), (c) or (e), 24(3)(a), (b) or (d) or subsection 24(5), by that person, or

7. Subsection 53(4) of the Regulations is repealed.

8. (1) Subsection 65(2) of the Regulations is replaced by the following:

(2) Subject to subsection (5), on receipt of a prescription or a written order, signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic other than dried marihuana to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal.

(2) Subsection 65(4) of the Regulations is replaced by the following:

(4) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic other than dried marihuana to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.

(3) Subsection 65(7) of the Regulations is repealed.

9. (1) Subitem 1(10) of the schedule to the Regulations is repealed.

(2) Item 1 of the schedule to the Regulations is amended by adding the following after subitem (33):

  • (33.1) Diacetylmorphine (heroin) and its salts
NEW CLASSES OF PRACTITIONERS REGULATIONS

10. (1) Paragraph 4(1)(c) of the New Classes of Practitioners Regulations (see footnote 3) is replaced by the following:

  • (c) any of subitems 1(1), 2(1), 5(4), 10(1) and 17(2) of the schedule to the Narcotic Control Regulations.

(2) Paragraph 4(2)(b) of the Regulations is replaced by the following:

  • (b) subitem 1(1) or 2(1) of the schedule to the Narcotic Control Regulations.

FOOD AND DRUGS ACT

FOOD AND DRUG REGULATIONS

11. Section C.08.010 of the Food and Drug Regulations (see footnote 4) is amended by adding the following after subsection (1):

(1.1) The Director shall not issue a letter of authorization under subsection (1) for a new drug that is or that contains a restricted drug as defined in section J.01.001.

TRANSITIONAL PROVISION

12. If, on the day on which these Regulations come into force, the Director has not yet issued a letter of authorization under subsection C.08.010(1) of the Food and Drug Regulations in response to a request that was made by a practitioner before that day, subsection C.08.010(1.1) of those Regulations, as enacted by section 11, applies in respect of the request.

APPLICATION BEFORE PUBLICATION

13. For the purpose of paragraph 11(2)(a) of the Statutory Instruments Act, these Regulations apply before they are published in the Canada Gazette.

COMING INTO FORCE

14. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issue

Health Canada has the authority under the Food and Drug Regulations (FDR) to permit the sale of an unapproved drug for the emergency treatment of a patient. The Government is concerned that the Special Access Programme (SAP) could be used to give individuals access to heroin, unauthorized products containing cocaine (benzoylmethylecgonine) and “restricted drugs” (defined in Part J of the FDR). Accordingly, amendments to the FDR and the Narcotic Control Regulations (NCR), with consequential amendments to the New Classes of Practitioners Regulations (NCPR), are needed to prevent access to these substances through the programme.

Background

Health Canada’s Special Access Programme (SAP) allows practitioners to request access to drugs that are not available in Canada for the treatment of a patient with a serious or life-threatening condition.

The authority for the SAP is found in sections C.08.010 and C.08.011 of the FDR, which permit the Director (Assistant Deputy Minister of the Health Products and Food Branch) to authorize the sale of a drug to a physician for emergency treatment purposes. Sales authorized through the SAP are exempt from all other provisions of the Food and Drugs Act and the FDR.

Sales of controlled substances through the SAP are also subject to the requirements of the Controlled Drugs and Substances Act (CDSA) and related regulations.

The CDSA provides a legislative framework for the control of substances that can alter mental processes and that may produce harm to the health of an individual or to society when diverted or misused. Except as authorized under its regulations, activities such as possession, possession for the purpose of trafficking, trafficking, importation, exportation, possession for the purpose of exportation and production of controlled substances are prohibited under the CDSA.

Substances listed in the Schedule to Part J of the FDR are defined as “restricted drugs” (e.g. bath salts, LSD) and under these Regulations can only be used for scientific and research purposes. If a product that contains a “restricted drug” were to receive a market authorization from Health Canada to treat, prevent or diagnose a medical condition, the restricted drug would then be appropriately regulated under the CDSA to allow for its sale and distribution.

Objectives

The objective of this proposal is to prevent “restricted drugs,” heroin and unauthorized products containing cocaine from being sold through Health Canada’s SAP.

Description

The Regulations include amendments to the FDR (Part J and the SAP provisions in Part C), the NCR, and the NCPR.

The Regulations transfer regulatory oversight for heroin from the NCR to Part J of the FDR. This is achieved by adding heroin to the Schedule of “restricted drugs” in Part J, and removing it from the Schedule of the NCR, and as a result, from the definition of “narcotic” within those Regulations (NCR).

The Regulations amend the definition of “restricted drug” to include any cocaine products that are not otherwise authorized by Health Canada to be sold on the market or within the context of an approved clinical trial, or are not being compounded by a pharmacist (as defined within the Regulations) by prescription.

The Regulations amend section C.08.010 of the FDR to prohibit the Director from authorizing the sale of a restricted drug, as defined in section J.01.001 of the FDR, for emergency treatment. This amendment in conjunction with the amendments to Part J would prevent the sale of heroin, cocaine and the “restricted drugs” (listed in the Schedule to Part J) through the SAP.

Since the NCR will no longer apply to heroin, a number of consequential amendments are also needed to remove all references or provisions relating to heroin from the NCR and the NCPR.

The Regulations would come into force and apply upon registration. If there are any outstanding SAP requests that have not been authorized on the day the Regulations come into force, the amendments to section C.08.010 would apply.

“One-for-One” Rule

Due to the nature of the proposed Regulations, there are no anticipated incremental costs. Therefore, the “One-for-One” Rule does not apply to this proposal.

Small business lens

The small business lens applies to regulatory proposals that impact small business and that have nationwide cost impacts of over $1 million annually. In this case, only manufacturers of restricted drugs would be affected by the proposal and they are considered very unlikely to meet the definition of small business. Therefore, the small business lens does not apply.

Rationale

In keeping with the objectives of the proposal, the Regulations include targeted amendments to prevent the sale of heroin, unauthorized products containing cocaine, and “restricted drugs” through the SAP.

The lowered threshold for SAP applications to demonstrate credible and plausible evidence of safety and effectiveness rather than substantial evidence of clinical effectiveness is not appropriate for restricted drugs where medical and ethical controversies with respect to their use as medicines exist.

The existing authorities to permit the sale of “restricted drugs” for clinical or scientific research purposes have not changed.

Implementation, enforcement and service standards

Not applicable.

Contact

Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
150 Tunney’s Pasture Driveway
Room 0305-392
Mail Stop 0300B
Ottawa, Ontario
K1A 0K9
Email: OCS-BSC@hc-sc.gc.ca