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:
- (iii) pour le titulaire d’un poste mentionné à l’alinéa G.02.001.1c), le nom du demandeur et le titre du poste;
(2) Subparagraph G.02.003(1)(f)(v) of the English version of the Regulations is replaced by the following:
- (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other licensed dealer;
(3) Subparagraph G.02.003(1)(h)(iii) of the English version of the Regulations is replaced by the following:
- (iii) if the controlled drug would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other licensed dealer;
(4) Paragraph G.02.003(3)(f) of the French version of the Regulations is replaced by the following:
- f) dans le cas où le nom du demandeur figure sur l’étiquette d’un produit ou d’un composé contenant une drogue contrôlée, une copie de l’étiquette intérieure, au sens de l’article A.01.010, de chaque produit ou composé visé par la licence;
2. (1) Paragraph G.02.003.2(b) of the Regulations is replaced by the following:
- (b) the name of the licensed dealer or the title of the position they hold, or, if the licensed dealer is a corporation, its corporate name;
(2) The portion of paragraph G.02.003.2(i) of the Regulations before subparagraph (i) is replaced by the following:
- (i) any conditions to be met by the licensed dealer to
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
- (a) send a notice to the applicant or to the licensed dealer, together with a written report that sets out the reasons for the proposed refusal or revocation; and
- (b) give the applicant or the licensed dealer an opportunity to be heard in respect of the proposed refusal or revocation.
(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
- (a) fails to comply with the Minister’s decision to suspend the permit under section G.02.011.2; or
- (b) fails to rectify the situation giving rise to the suspension within the period referred to in subsection G.02.011.2(3).
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:
- (b) at the time of receipt of the order the licensed dealer temporarily does not have in stock the quantity of the drug ordered, in which case the licensed dealer may sell or provide against the order the quantity of the drug that the licensed dealer has available and deliver the balance later in accordance with the order.
8. Paragraph G.03.014(a) of the English version of the Regulations is replaced by the following:
- (a) the licensed dealer who sold or provided that drug to them, return that drug to that licensed dealer;
9. (1) Subparagraph J.01.007(1)(a)(iii) of the French version of the Regulations is replaced by the following:
- (iii) pour le titulaire d’un poste mentionné à l’alinéa J.01.003.1c), le nom du demandeur et le titre du poste;
(2) Subparagraph J.01.007(1)(g)(v) of the English version of the Regulations is replaced by the following:
- (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other licensed dealer;
(3) Subparagraph J.01.007(1)(h)(iii) of the English version of the Regulations is replaced by the following:
- (iii) if the restricted drug would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other licensed dealer;
(4) Paragraph J.01.007(3)(f) of the French version of the Regulations is replaced by the following:
- f) dans le cas où le nom du demandeur figure sur l’étiquette d’un produit ou d’un composé contenant une drogue d’usage restreint, une copie de l’étiquette intérieure, au sens de l’article A.01.010, de chaque produit ou composé visé par la licence;
10. (1) Paragraph J.01.007.2(b) of the Regulations is replaced by the following:
- (b) the name of the licensed dealer or the title of the position they hold, or, if the licensed dealer is a corporation, its corporate name;
(2) The portion of paragraph J.01.007.2(i) of the Regulations before subparagraph (i) is replaced by the following:
- (i) any conditions to be met by the licensed dealer to
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
- (a) send a notice to the applicant or to the licensed dealer, together with a written report that sets out the reasons for the proposed refusal or revocation; and
- (b) give the applicant or the licensed dealer an opportunity to be heard in respect of the proposed refusal or revocation.
(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
- (a) fails to comply with the Minister’s decision to suspend the permit under section J.01.012.2; or
- (b) fails to rectify the situation giving rise to the suspension within the period referred to in subsection J.01.012.2(3).
14. The French version of the Regulations is amended by replacing “distributeur autorisé” with “distributeur” in the following provisions:
- (a) paragraph G.02.001.2(1)(a);
- (b) clause G.02.003.6(1)(a)(ii)(C);
- (c) paragraph G.02.003.8(2)(a);
- (d) the portion of paragraph G.02.025(1)(b) before subparagraph (i);
- (e) paragraph J.01.003.2(1)(a);
- (f) clause J.01.007.6(1)(a)(ii)(C); and
- (g) paragraph J.01.007.8(2)(a).
15. The French version of the Regulations is amended by replacing “titulaire” with “distributeur” in the following provisions:
- (a) section G.02.003.7;
- (b) paragraphs G.02.003.8(1)(b), (c) and (e);
- (c) section J.01.007.7; and
- (d) paragraphs J.01.007.8(1)(b), (c) and (e).
16. The French version of the Regulations is amended by replacing “à laquelle s’appliquerait” with “visée par” in the following provisions:
- (a) paragraph G.02.003(1)(g) and subparagraph (3)(g)(ii);
- (b) paragraph G.02.003.4(2)(a);
- (c) paragraph G.02.003.5(2)(a);
- (d) paragraph J.01.007(1)(f) and subparagraph (3)(g)(ii);
- (e) paragraph J.01.007.4(2)(a); and
- (f) paragraph J.01.007.5(2)(a).
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:
- (iii) pour le titulaire d’un poste mentionné à l’alinéa 8.2c), le nom du demandeur et le titre du poste;
(2) Subparagraph 9(1)(g)(v) of the English version of the Regulations is replaced by the following:
- (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other licensed dealer;
(3) Subparagraph 9(1)(h)(iii) of the English version of the Regulations is replaced by the following:
- (iii) if the narcotic would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other licensed dealer;
(4) Paragraph 9(3)(f) of the French version of the Regulations is replaced by the following:
- f) dans le cas où le nom du demandeur figure sur l’étiquette d’un produit ou d’un composé contenant un stupéfiant, une copie de l’étiquette intérieure, au sens de l’article A.01.010 du Règlement sur les aliments et drogues, de chaque produit ou composé visé par la licence;
18. (1) Paragraph 9.2(b) of the Regulations is replaced by the following:
- (b) the name of the licensed dealer or the title of the position they hold, or, if the licensed dealer is a corporation, its corporate name;
(2) The portion of paragraph 9.2(i) of the Regulations before subparagraph (i) is replaced by the following:
- (i) any conditions to be met by the licensed dealer to
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
- (a) send a notice to the applicant or to the licensed dealer, together with a written report that sets out the reasons for the proposed refusal or revocation; and
- (b) give the applicant or the licensed dealer an opportunity to be heard in respect of the proposed refusal or revocation.
(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
- (a) fails to comply with the Minister’s decision to suspend the permit under section 13.2; or
- (b) fails to rectify the situation giving rise to the suspension within the period referred to in subsection 13.2(3).
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:
- (a) return the narcotic to the licensed dealer who sold or provided it to the pharmacist, if the order is signed and dated by the licensed dealer; or
25. Paragraph 65.3(c) of the English version of the Regulations is replaced by the following:
- (c) sold or provided, for destruction, to a licensed dealer who is authorized to destroy dried marihuana, if the order is signed and dated by the licensed dealer.
26. The French version of the Regulations is amended by replacing “distributeur autorisé” with “distributeur” in the following provisions:
- (a) paragraph 8.3(1)(a);
- (b) clause 9.7(1)(a)(ii)(C);
- (c) paragraph 9.9(2)(a);
- (d) paragraph 27(2)(b); and
- (e) paragraph 27(7)(e).
27. The French version of the Regulations is amended by replacing “à laquelle s’appliquerait” with “visée par” in the following provisions:
- (a) paragraph 9(1)(f) and subparagraph (3)(g)(ii);
- (b) paragraph 9.5(2)(a); and
- (c) paragraph 9.6(2)(a).
28. The French version of the Regulations is amended by replacing “titulaire” with “distributeur” in the following provisions:
- (a) section 9.8; and
- (b) paragraphs 9.9(1)(b), (c) and (e).
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:
- (b) the licensed dealer has insufficient stock of the substance at the time of receipt of the order, in which case the licensed dealer may supply the quantity of the substance that the licensed dealer has in stock and may deliver the balance afterwards in a single supplementary delivery.
31. (1) Subparagraph 20(1)(a)(i) of the French version of the Regulations is replaced by the following:
- (i) son nom ou, s’il s’agit d’une personne morale, sa dénomination sociale et tout autre nom enregistré auprès d’une province sous lequel le demandeur entend poursuivre les opérations prévues dans la licence ou s’identifier,
(2) Subparagraph 20(1)(f)(v) of the English version of the Regulations is replaced by the following:
- (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and dealer’s licence number of that other licensed dealer;
(3) Subparagraph 20(1)(g)(iii) of the English version of the Regulations is replaced by the following:
- (iii) if the substance would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of that other licensed dealer;
(4) Subparagraph 20(3)(g)(ii) of the French version of the Regulations is replaced by the following:
- (ii) une copie de tout document déposé auprès de la province où se trouve le local visé par la licence, qui indique sa dénomination sociale ou tout autre nom enregistré auprès de la province sous lequel le demandeur entend poursuivre les opérations prévues dans la licence ou s’identifier.
32. Paragraph 21(b) of the Regulations is replaced by the following:
- (b) the name of the licensed dealer or, if the licensed dealer is a corporation, its corporate name;
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:
- b) soit que les pharmaciens qui exercent dans ces pharmacies ne peuvent plus exécuter les ordonnances ou les commandes de substances ciblées émanant de ce praticien.
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:
- (a) licensed dealers and pharmacists practising in the notified pharmacies must not sell or provide any targeted substance to the pharmacist or the practitioner named in the notice;
(2) Paragraph 79(1)(b) of the French version of the Regulations is replaced by the following:
- b) soit que les pharmaciens qui exercent dans les pharmacies avisées ne peuvent plus exécuter les ordonnances ou les commandes de substances ciblées émanant du praticien nommé dans l’avis;
(3) Paragraph 79(3)(d) of the English version of the Regulations is replaced by the following:
- (d) any provincial professional licensing authority in another province that has made a request to the Minister to issue the notice; and
39. The French version of the Regulations is amended by replacing “distributeur autorisé” with “distributeur” in the following provisions:
- (a) paragraph 19(1)(a);
- (b) paragraph 20(4)(b);
- (c) clause 26(1)(a)(ii)(C) and paragraph (2)(c);
- (d) paragraph 28(2)(a);
- (e) paragraphs 33(2)(b) and (c);
- (f) paragraph 34(1)(g); and
- (g) paragraph 50(c).
40. The French version of the Regulations is amended by replacing “titulaire” with “distributeur” in the following provisions:
- (a) section 27; and
- (b) paragraphs 28(1)(b) and (c).
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:
- NCR: 8.3(1)(a); 9.8; 9.9; 27(2);
- FDR-G: G.02.001.2(1); G.02.003.7; G.02.003.8(1)(b), (c); G.02.003.8(2); and
- FDR-J: J.01.003.2(1); J.01.007.6(1); J.01.007.7; J.01.007.8(1)(b), (c); J.01.007.8(2).
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.
- Using terms “practise” and “exercer” in both English and French versions: 48; 54(3); 62(b); 64; 79(1)a); 79(1)b) with necessary grammatical changes.
- Replacing “enregistré” with “enregistré auprès de” in the French version: 20(1)a)(i); 20(3)g)(ii) with necessary grammatical changes.
- Deleting “interested” in the English version in paragraph 79(3)(d).
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
- Footnote a
S.C. 1996, c. 19 - Footnote 1
C.R.C, c. 870 - Footnote 2
C.R.C., c. 1041 - Footnote 3
SOR/2000-217