Vol. 148, No. 24 — November 19, 2014

Registration

SOR/2014-260 November 7, 2014

CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending Certain Regulations Made Under the Controlled Drugs and Substances Act (Miscellaneous Program)

P.C. 2014-1250 November 6, 2014

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote a), makes the annexed Regulations Amending Certain Regulations Made Under the Controlled Drugs and Substances Act (Miscellaneous Program).

REGULATIONS AMENDING CERTAIN REGULATIONS MADE UNDER THE CONTROLLED DRUGS AND SUBSTANCES ACT (MISCELLANEOUS PROGRAM)

FOOD AND DRUG REGULATIONS

1. (1) Subparagraph G.02.003(1)(a)(iii) of the French version of the Food and Drug Regulations (see footnote 1) is replaced by the following:

(2) Subparagraph G.02.003(1)(f)(v) of the English version of the Regulations is replaced by the following:

(3) Subparagraph G.02.003(1)(h)(iii) of the English version of the Regulations is replaced by the following:

(4) Paragraph G.02.003(3)(f) of the French version of the Regulations is replaced by the following:

2. (1) Paragraph G.02.003.2(b) of the Regulations is replaced by the following:

(2) The portion of paragraph G.02.003.2(i) of the Regulations before subparagraph (i) is replaced by the following:

3. The portion of subsection G.02.003.5(3) of the Regulations before paragraph (a) is replaced by the following:

(3) Subject to section G.02.003.3, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application and may add any conditions to be met by the licensed dealer to

4. Subsections G.02.003.91(1) and (2) of the Regulations are replaced by the following:

G.02.003.91. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer’s licence under this Part, the Minister shall

(2) The suspension of a dealer’s licence under this Part takes effect as soon as the Minister notifies the licensed dealer of the decision to suspend and provides a written report that sets out the reasons for the suspension.

5. Subsection G.02.011.1(3) of the Regulations is replaced by the following:

(3) The Minister may revoke a permit if the holder

6. The portion of subsection G.02.025(8) of the English version of the Regulations before paragraph (a) is replaced by the following:

(8) If a licensed dealer has not received a receipt from a pharmacist or practitioner under subsection (7) within the time prescribed by that subsection, the licensed dealer shall not, until after receiving the receipt, sell or provide a controlled drug to the pharmacist or practitioner pursuant to a further

7. Paragraph G.02.026(b) of the Regulations is replaced by the following:

8. Paragraph G.03.014(a) of the English version of the Regulations is replaced by the following:

9. (1) Subparagraph J.01.007(1)(a)(iii) of the French version of the Regulations is replaced by the following:

(2) Subparagraph J.01.007(1)(g)(v) of the English version of the Regulations is replaced by the following:

(3) Subparagraph J.01.007(1)(h)(iii) of the English version of the Regulations is replaced by the following:

(4) Paragraph J.01.007(3)(f) of the French version of the Regulations is replaced by the following:

10. (1) Paragraph J.01.007.2(b) of the Regulations is replaced by the following:

(2) The portion of paragraph J.01.007.2(i) of the Regulations before subparagraph (i) is replaced by the following:

11. The portion of subsection J.01.007.5(3) of the Regulations before paragraph (a) is replaced by the following:

(3) Subject to section J.01.007.3, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application and may add any conditions to be met by the licensed dealer to

12. Subsections J.01.007.91(1) and (2) of the Regulations are replaced by the following:

J.01.007.91. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer’s licence under this Part, the Minister shall

(2) The suspension of a licence under this Part takes effect as soon as the Minister notifies the licensed dealer of the decision to suspend and provides a written report that sets out the reasons for the suspension.

13. Subsection J.01.012.1(3) of the Regulations is replaced by the following:

(3) The Minister may revoke a permit if the holder

14. The French version of the Regulations is amended by replacing “distributeur autorisé” with “distributeur” in the following provisions:

15. The French version of the Regulations is amended by replacing “titulaire” with “distributeur” in the following provisions:

16. The French version of the Regulations is amended by replacing “à laquelle s’appliquerait” with “visée par” in the following provisions:

NARCOTIC CONTROL REGULATIONS

17. (1) Subparagraph 9(1)(a)(iii) of the French version of the Narcotic Control Regulations (see footnote 2) is replaced by the following:

(2) Subparagraph 9(1)(g)(v) of the English version of the Regulations is replaced by the following:

(3) Subparagraph 9(1)(h)(iii) of the English version of the Regulations is replaced by the following:

(4) Paragraph 9(3)(f) of the French version of the Regulations is replaced by the following:

18. (1) Paragraph 9.2(b) of the Regulations is replaced by the following:

(2) The portion of paragraph 9.2(i) of the Regulations before subparagraph (i) is replaced by the following:

19. The portion of subsection 9.6(3) of the Regulations before paragraph (a) is replaced by the following:

(3) Subject to section 9.4, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application and may add any conditions to be met by the licensed dealer to

20. Subsections 9.92(1) and (2) of the Regulations are replaced by the following:

9.92 (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer’s licence under these Regulations, the Minister shall

(2) The suspension of a dealer’s licence under these Regulations takes effect as soon as the Minister notifies the licensed dealer of the decision to suspend and provides a written report that sets out the reasons for the suspension.

21. Subsection 13.1(3) of the Regulations is replaced by the following:

(3) The Minister may revoke a permit if the holder

22. Subsection 24(2.2) of the Regulations is replaced by the following:

(2.2) No licensed dealer shall sell or provide dried marihuana to any person referred to in paragraphs (2)(b) to (d) unless the licensed dealer produced it under contract with Her Majesty in right of Canada.

23. The portion of subsection 27(9) of the English version of the Regulations before paragraph (a) is replaced by the following:

(9) If a licensed dealer has not obtained a receipt from a pharmacist or practitioner under subsection (8) within the time prescribed by that subsection, the licensed dealer shall not, until after obtaining the receipt, sell or provide a narcotic to the pharmacist or practitioner pursuant to any further

24. Paragraph 45(1)(a) of the English version of the Regulations is replaced by the following:

25. Paragraph 65.3(c) of the English version of the Regulations is replaced by the following:

26. The French version of the Regulations is amended by replacing “distributeur autorisé” with “distributeur” in the following provisions:

27. The French version of the Regulations is amended by replacing “à laquelle s’appliquerait” with “visée par” in the following provisions:

28. The French version of the Regulations is amended by replacing “titulaire” with “distributeur” in the following provisions:

BENZODIAZEPINES AND OTHER TARGETED SUBSTANCES REGULATIONS

29. (1) The portion of subsection 16(1) of the English version of the Benzodiazepines and Other Targeted Substances Regulations (see footnote 3) before paragraph (a) is replaced by the following:

Order required

16. (1) Subject to subsection (4), a licensed dealer must not sell or provide a targeted substance to a person referred to in paragraph 15(2)(c) before the licensed dealer has received an order for the substance, either in writing in accordance with subsection (2) or verbally and recorded in accordance with subsection (3), from

(2) Subsection 16(4) of the English version of the Regulations is replaced by the following:

Supply prohibited

(4) A licensed dealer must not sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79, unless the licensed dealer has received a retraction issued under section 80.

30. Paragraph 17(b) of the English version of the Regulations is replaced by the following:

31. (1) Subparagraph 20(1)(a)(i) of the French version of the Regulations is replaced by the following:

(2) Subparagraph 20(1)(f)(v) of the English version of the Regulations is replaced by the following:

(3) Subparagraph 20(1)(g)(iii) of the English version of the Regulations is replaced by the following:

(4) Subparagraph 20(3)(g)(ii) of the French version of the Regulations is replaced by the following:

32. Paragraph 21(b) of the Regulations is replaced by the following:

33. Subsection 47(3) of the French version of the Regulations is replaced by the following:

Exceptions

(3) Sauf s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement de la substance ciblée vers un marché ou un usage illicite, le ministre ne révoque pas le permis d’exportation dans les circonstances visées aux alinéas (2)b), 28(1)a) ou 28(1)b) si son titulaire remplit les conditions prévues aux alinéas 28(2)a) et b), compte tenu des adaptations nécessaires.

34. Section 48 of the French version of the Regulations is replaced by the following:

Application

48. La présente partie, à l’exception de l’article 57, ne s’applique pas au pharmacien lorsqu’il exerce dans un hôpital.

35. Subsection 54(3) of the French version of the Regulations is replaced by the following:

Consignation — pharmacien cédant

(3) Le pharmacien qui transfère une ordonnance en vertu du paragraphe (1) doit consigner la date du transfert, le nom du pharmacien auquel il effectue le transfert, les nom et adresse de la pharmacie où ce dernier exerce et, le cas échéant, le nombre de renouvellements visés par le transfert.

36. Paragraph 62(b) of the French version of the Regulations is replaced by the following:

37. Section 64 of the French version of the Regulations is replaced by the following:

Fourniture ou administration à un patient

64. Le responsable d’un hôpital ne peut permettre qu’une substance ciblée soit vendue, fournie ou administrée à un patient ou pour un animal qui y reçoit des soins en tant que patient interne ou patient externe, sauf sur ordonnance ou selon une autre autorisation d’un praticien exerçant à cet hôpital.

38. (1) Paragraph 79(1)(a) of the Regulations is replaced by the following:

(2) Paragraph 79(1)(b) of the French version of the Regulations is replaced by the following:

(3) Paragraph 79(3)(d) of the English version of the Regulations is replaced by the following:

39. The French version of the Regulations is amended by replacing “distributeur autorisé” with “distributeur” in the following provisions:

40. The French version of the Regulations is amended by replacing “titulaire” with “distributeur” in the following provisions:

COMING INTO FORCE

41. 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 and objectives

This regulatory initiative responds to issues raised by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) in 2012 in relation to the Benzodiazepines and Other Targeted Substances Regulations (BOTSR), the Narcotic Control Regulations (NCR) and Parts G and J of the Food and Drug Regulations (FDR-G, FDR-J).

The SJCSR is a joint committee of the House and Senate established to review and make recommendations regarding regulations and statutory instruments on the basis of legality and procedural aspects, as opposed to their merits or policy basis. Although rarely exercised, the Committee has the power to table a disallowance report in the House of Commons should their recommendations not be followed.

In 2010, in response to issues identified by the SJCSR, Health Canada amended certain provisions in the BOTSR, NCR, FDR-G and FDR-J. These amendments were published in the Canada Gazette, Part II, in November 2010 (http://www.gazette.gc.ca/rp-pr/p2/2010/2010-11-10/html/index-eng.html). Further to these amendments, the Committee has raised additional issues with the above-mentioned regulations. Most of the issues relate to clarity and consistency for certain provisions which may cause presumption of different intended meanings. After reviewing the matters raised by the SJCSR, Health Canada decided to amend the regulations in question to address these issues.

Within this context, this regulatory initiative aims to ensure further consistency and clarity of BOTSR, NCR, FDR-G and FDR-J by amending these regulations with editorial and/or linguistic changes based on suggestions by the SJCSR on certain provisions as outlined below.

Description

The Regulations amend the following provisions in the BOTSR, FDR-G, FDR-J and NCR. All of the amendments are editorial and linguistic in nature.

Use of terms “distributeur autorisé” and “distributeur

To ensure the consistent use of the term “distributeur” after a preceding reference to “licence de distributeur autorisé” or “distributeur autorisé” in a section or subsection, the following provisions have been amended to reflect such drafting approach:

Use of the expression “l’installation visée par la licence”

Paragraph 9(1)(f) of the NCR, paragraph G.02.003(1)(g) of the FDR-G and paragraph J.01.007(1)(f) of the FDR-J have been amended by replacing “l’installation à laquelle s’appliquerait la licence” with “l’installation visée par la licence” in the French version so the provisions in question will be consistent between the English and French versions.

Timeframe with respect to permit revocation

Provisions in the NCR, FDR-G and FDR-J indicate that in the case of a permit suspension, the Minister of Health will give a permit holder 10 days to provide reasons why the suspension is unfounded. However, the SJCSR has identified ambiguity in subsection 13.1(3) of the NCR, subsection G.02.011.1(3) of the FDR-G and subsection J.01.012.1(3) of the FDR-J regarding permit revocation as those provisions do not specify any timeframe within which the Minister of Health may revoke a suspended permit. To ensure further clarity, the above-mentioned provisions have been amended to indicate that the revocation of a suspended permit should not occur prior to the expiration of the 10-day period within which a permit holder may provide the Minister with reasons why they believe the permit suspension is unfounded.

Consistency between the English and French versions of the BOTSR

In the BOTSR, the following provisions have been amended to ensure the consistent use of terms in both English and French.

Correction on provision reference

Subsection 47(3) will be amended by replacing “alinéas (2)b), 28(2)a) ou 28(2)b)” with “alinéas (2)b), 28(1)a) ou 28(1)b)” in the French version.

Consultation

The purpose of the miscellaneous amendments regulations process is to streamline the regulatory process by shortening the total time taken to make minor and technical amendments to existing regulations. These amendments do not either alter the intent of the regulations or impose new restrictions or burdens on individuals or industry. Within this context, no external consultation on the substance of these amendments has been carried out because these amendments do not impose new restrictions or burdens on the general public or any party subject to the controls set out in the regulations.

“One-for-One” Rule and small business lens

The “One-for-One” Rule and the small business lens do not apply to this proposal, as the amendments do not result in any changes in costs to any type of business.

Rationale

The amendments are made further to the recommendation of the SJCSR in order to clarify certain provisions within these Regulations and to ensure consistency between the French and English versions of these Regulations.

Contact

Denis Arsenault
Regulatory Policy Division
Office of Policy and Strategic Planning
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Address Locator: 0302A
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0B9
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca