Vol. 139, No. 25 — December 14, 2005

Registration
SOR/2005-365 November 21, 2005

CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending the Precursor Control Regulations

P.C. 2005-2110 November 21, 2005

Her 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), hereby makes the annexed Regulations Amending the Precursor Control Regulations.

REGULATIONS AMENDING THE PRECURSOR CONTROL REGULATIONS

AMENDMENTS

1. Section 1 of the Precursor Control Regulations (see footnote 1) is amended by adding the following in alphabetical order:

"hospital" means a facility that

(a) is licensed, approved or designated as a hospital by a province under the laws of the province to provide health care or treatment to persons or animals; and

(b) is owned or operated by the Government of Canada or a province and that provides health services. (hôpital)

"peace officer" means a peace officer as defined in section 2 of the Criminal Code. (agent de la paix)

"pharmacist" means an individual who

(a) is registered or otherwise authorized under the laws of a province to practise pharmacy; and

(b) is practising pharmacy in that province. (pharmacien)

"prescription" means, in respect of a preparation or mixture containing a Class A precursor, an authorization from a practitioner stating that a specific amount of the preparation or mixture may be sold or provided for the individual or animal under the practitioner's care named in the authorization. (ordonnance)

"retail" means a sale or provision of goods for the purpose of end-use but not resale. (au détail)

2. Section 2 of the Regulations is replaced by the following:

2. With respect to a drug in dosage form, a person who sells or provides or possesses for the purpose of sale or provision, or who conducts an activity mentioned in section 9 or 47, is exempt from the requirements of these Regulations in respect of that activity if the drug contains

(a) a Class A precursor listed in Schedule F to the Food and Drug Regulations; or

(b) a Class A precursor and one or more controlled substances listed in Schedule I, III or IV to the Act.

3. (1) The portion of section 3 of the Regulations before subparagraph (a)(ii) is replaced by the following:

3. With respect to a Class A precursor that is a preparation or mixture, a person who conducts an activity mentioned in section 6, 9, 10 or 47 is exempt from the requirements of these Regulations, except requirements in respect of the production of the preparation or mixture or the possession of a precursor for the purpose of producing the preparation or mixture, if

(a) the preparation or mixture is a fragrance or flavouring

(2) Section 3 of the Regulations is amended by striking out the word "or" at the end of subparagraph (a)(ii), by adding the word "or" at the end of paragraph (b) and by adding the following after paragraph (b):

(c) it contains gamma butyrolactone or 1,4-butanediol in a total concentration equal to or less than 20% by weight or volume in the case of a solid or liquid respectively, and is intended to be used in the following products or processes:

4. Sections 4 and 5 of the Regulations are replaced by the following:

4. (1) A person who uses a Class A precursor that is described in section 3 or is the subject of an authorization certificate under section 49, to produce another Class A precursor that is a preparation or mixture, is exempt from the requirements of these Regulations in respect of that production.

(2) With respect to a preparation or mixture produced under subsection (1), a person who conducts any activity mentioned in section 6, 9, 10 or 47 is exempt from the requirements of these Regulations in respect of the activity.

5. With respect to any Class A precursor, a person who only sells, provides or possesses for the purpose of sale or provision is exempt from the requirements of these Regulations in respect of the activity if the person

(a) sells or provides a selection of goods that is not limited to chemicals or chemicals and equipment used in the chemical industry for the production, processing or storage of chemicals; and

(b) sells or provides Class A precursors

5. The Regulations are amended by adding the following after section 6:

6.1 No person may possess a Class A precursor for the purpose of producing a controlled substance unless the person is the holder of

(a) a licence issued under section G.02.003.2 or J.01.007.2 of the Food and Drug Regulations, section 21 of the Benzodiazepines and Other Targeted Substances Regulations or section 9.2 of the Narcotic Control Regulations that authorizes the production of the substance; or

(b) an exemption issued under section 56 of the Act.

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

8. (1) A licensed dealer who intends to sell or provide, to a person who is not a licensed dealer, a Class A precursor set out in column 1 of the schedule in a quantity, per transaction, greater than the maximum quantity, expressed as an absolute quantity or per package, specified for the precursor in column 2 of the schedule shall, before entering into the transaction, obtain an end-use declaration signed and dated by the person acquiring the precursor.

(1.1) The end-use declaration shall include

(a) the name of the licensed dealer, being, in the case of a corporation, its corporate name, as well as their address and telephone number and facsimile transmission number, if any;

(b) the name of the person acquiring the precursor, being, in the case of a corporation, its corporate name, as well as their address and telephone number and facsimile transmission number, if any;

(c) the name of all Class A precursors involved in the transactions mentioned in the end-use declaration;

(d) all uses for which the precursor is being acquired; and

(e) a certification by the signatory stating that the person is acquiring the precursor as the end user, for the uses mentioned in the end-use declaration.

(2) Subsection 8(3) of the French version of the Regulations is replaced by the following:

(3) La déclaration d'utilisation finale obtenue aux termes du paragraphe (1) ou (2) vaut pour toutes les transactions subséquentes, entre le distributeur autorisé et le signataire de la déclaration, qui ont lieu au cours de l'année civile pendant laquelle s'est effectuée la transaction visée aux paragraphes (1) ou (2) et qui visent le même précurseur de catégorie A et les mêmes usages que ceux spécifiés dans la déclaration.

7. (1) Subsection 9(1) of the Regulations is amended by striking out the word "or" at the end of paragraph (a) and by adding the following after paragraph (b):

(c) the end user of the precursor; or

(d) a representative of the end user.

(2) Section 9 of the Regulations is amended by adding the following after subsection (1):

(1.1) A person sending, transporting or delivering a Class A precursor set out in column 1 of the schedule in a quantity greater than the maximum quantity, expressed as an absolute quantity or per package, specified for the precursor in column 2 of the schedule, shall ensure that the precursor is accompanied by documentation indicating

(a) the name and quantity of the precursor;

(b) the name of the licensed dealer selling or providing the precursor;

(c) the name of the person to whom the precursor is being sent, transported or delivered; and

(d) the date the precursor was sent.

8. The Regulations are amended by adding the following after section 9:

9.1 If a rail car, reusable container, intermodal tank container or other container, having a capacity of 9,000 L or more, was used to provide or send red or white phosphorus and the rail car or container is returned to the person who produced the phosphorous with residual amounts that cannot be offloaded under normally accepted operating procedures in the chemical industry, the person returning the rail car or container in that state is exempt from the requirements of these Regulations in respect of that activity.

9. The Regulations are amended by adding the following after section 10:

Authorization Concerning Preparations and Mixtures

10.1 Despite sections 6 to 10 and 47, with respect to a Class A precursor that is a preparation or mixture, a person may sell, provide, send, transport, deliver, import, export, transport in transit through Canada, tranship in Canada, destroy or possess for those purposes if

(a) the preparation or mixture is the subject of an authorization certificate under section 49; and

(b) no notice indicating that the certificate has been revoked or is under suspension appears on the following Health Canada Internet site:

http://www.hc-sc.gc.ca/dhp-mps/substancontrol/index_e.html

10. (1) Paragraph 14(1)(a) of the Regulations is replaced by the following:

(a) the applicant's name or, if the applicant is a corporation, its corporate name, any other registered name with a province and any other trade name under which the applicant intends to carry out the activities set out in the licence or intends to identify itself;

(a.1) a description of the nature of the business conducted or intended to be conducted by the applicant;

(a.2) the length of time, if any, the applicant has been in business;

(2) Paragraph 14(1)(b) of the Regulations is amended by striking out the word "and" at the end of subparagraph (ii) and by adding the following after subparagraph (iii):

(3) Paragraph 14(1)(c) of the Regulations is replaced by the following:

(c) for each precursor mentioned in the application,

(c.1) if an establishment licence under section C.01A.008 of the Food and Drug Regulations has been issued to the applicant in respect of a Class A precursor, the number of the licence;

(c.2) if a site licence under section 29 or 36 of the Natural Health Products Regulations has been issued to the applicant in respect of a Class A precursor, the number of the licence;

(4) Paragraph 14(1)(h) of the Regulations is replaced by the following:

(h) a description of the proposed security measures to be used at the site and when a precursor is transported, sent or delivered, including the measures required under subsection 9(2), section 83 and subsection 85(3);

11. The Regulations are amended by adding the following after section 15:

Pre-licence Inspection

15.1 The Minister may, in respect of an applicant or a licensed dealer, at any reasonable time,

(a) require the inspection of the site used or intended to be used in producing, packaging, selling or providing a Class A precursor or to or from which a Class A precursor has been or is to be imported or exported;

(b) examine, as part of the inspection, the security measures used or put in place at the site and in respect of the sending, transportation or delivery of precursors;

(c) examine, as part of the inspection, the internal controls used or put in place at the site with respect to precursor activities; and

(d) examine, as part of the inspection, the books, registers, electronic data and other records held or put in place in accordance with section 85.

12. (1) Paragraph 17(1)(b) of the Regulations is replaced by the following:

(b) the Minister has reasonable grounds to believe that any information or document included in the application is false or misleading;

(2) Paragraphs 17(1)(e) and (f) of the Regulations are replaced by the following:

(e) information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the applicant has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use;

(f) the applicant does not have in place the security measures required under subsection 9(2), section 83 and subsection 85(3) with respect to the precursors sought to be licensed;

13. The heading before section 19 of the English version of the Regulations is replaced by the following:

Amendment of Licence

14. (1) Subsection 20(1) of the English version of the Regulations is amended by striking out the word "or" at the end of paragraphs (a) and (b) and by adding the following after paragraph (b):

(b.1) making a change to the security measures used at the site with respect to Class A precursors kept there or described in the licence application under paragraph 14(1)(h) or in a request for approval under this section; or

(2) Subsection 20(3) of the Regulations is replaced by the following:

(3) When requesting an approval under paragraph (1)(b.1) or (c), the licensed dealer must provide the Minister with the information that permits the Minister to make an evaluation required under paragraphs 17(1)(f) and (i).

15. Subsection 23(1) of the Regulations is amended by striking out the word "and" at the end of paragraph (d) and by replacing paragraph (e) with the following:

(e) information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the licensed dealer has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use; or

(f) the continuation of the licence would likely create a risk to public health, safety or security, including the risk of a Class A precursor being diverted to an illicit market or use.

16. Section 24 of the Regulations is replaced by the following:

24. The Minister shall suspend a licence without prior notice if the Minister has reasonable grounds

(a) to believe that the suspension is necessary to protect public health, safety or security; or

(b) to suspect that the continuation of the licence presents a risk of a Class A precursor being diverted to an illicit market or use.

17. (1) Paragraph 25(1)(e) of the Regulations is replaced by the following:

(e) the proposed means of transportation;

(e.1) the name of any proposed country of transit or transhipment;

(2) Paragraph 25(1)(g) of the Regulations is replaced by the following:

(g) the proposed port of entry into Canada;

(3) Paragraph 25(1)(i) of the Regulations is replaced by the following:

(i) the name and address of the proposed customs broker for the licensed dealer, if any; and

(4) Paragraph 25(2)(a) of the English version of the Regulations is replaced by the following:

(a) be signed by the responsible person in charge or the alternate responsible person in charge, if any, for the site to which the Class A precursor will be transported after being released under the Customs Act; and

18. The Regulations are amended by adding the following after section 28:

Declaration

28.1 (1) Within 15 days after a shipment containing a Class A precursor is released under the Customs Act, the holder of the Class A import permit for the shipment shall provide the Minister with a declaration containing the following information:

(a) the name of the holder and permit number for the shipment;

(b) the port of entry into Canada for the shipment;

(c) the date the shipment was released under the Customs Act;

(d) the name of the precursor being shipped or a description of its chemical composition, as stated in the permit; and

(e) the quantity of the precursor being shipped and, if it is a preparation or mixture, the quantity of all of the precursors set out in Part 1 of Schedule VI to the Act that it contains.

(2) The declaration must

(a) be signed by the responsible person in charge or the alternate responsible person in charge for the licensed site to which the shipment will be transported after being released under the Customs Act; and

(b) include a statement that all information set out in the declaration is correct and complete to the best of the knowledge of the signatory.

19. Subsection 30(1) of the Regulations is replaced by the following:

30. (1) Subject to subsection (2), the Minister shall revoke a Class A import permit in accordance with subsection 84(1) if

(a) a circumstance described in any of paragraphs 23(1)(a) to (f) exists with respect to the licence pertaining to the Class A precursor to be imported; or

(b) the permit was issued on the basis of false or misleading information or false or falsified documents.

20. Paragraph 31(b) of the Regulations is replaced by the following:

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;

(b.1) the Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class A precursor being diverted to an illicit market or use; or

21. (1) Paragraph 32(1)(e) of the Regulations is replaced by the following:

(e) the proposed means of transportation;

(e.1) the name of any proposed country of transit or transhipment;

(2) Paragraph 32(1)(g) of the Regulations is replaced by the following:

(g) the proposed port of exit from Canada;

(3) Paragraph 32(1)(i) of the Regulations is replaced by the following:

(i) the name and address of the proposed customs broker for the licensed dealer, if any;

22. The Regulations are amended by adding the following after section 35:

Declaration

35.1 (1) Within 15 days after a shipment containing a Class A precursor is exported, the holder of a Class A export permit for the shipment shall provide the Minister with a declaration containing the following information:

(a) the name of the holder and permit number for the shipment;

(b) the port of exit from Canada for the shipment;

(c) the date of export;

(d) the name of the precursor being shipped or a description of its chemical composition, as stated in the permit; and

(e) the quantity of the precursor being shipped and, if it is a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains.

(2) The declaration must

(a) be signed by the responsible person in charge or the alternate responsible person in charge for the licensed site from which the shipment will be transported to the port of exit; and

(b) include a statement that all information set out in the declaration is correct and complete to the best of the knowledge of the signatory.

23. Subsection 37(1) of the Regulations is replaced by the following:

37. (1) Subject to subsection (2), the Minister shall revoke a Class A export permit in accordance with subsection 84(1) if

(a) a circumstance described in any of paragraphs 23(1)(a) to (f) exists with respect to the licence pertaining to the Class A precursor to be exported; or

(b) the export permit was issued on the basis of false or misleading information or false or falsified documents.

24. Paragraph 38(b) of the Regulations is replaced by the following:

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;

(b.1) the Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class A precursor being diverted to an illicit market or use;

25. Paragraph 39(1)(f) of the Regulations is replaced by the following:

(f) the proposed ports of entry into and exit from Canada;

26. Subsection 45(1) of the Regulations is amended by striking out the word "or" at the end of paragraph (b) and by replacing paragraph (c) with the following:

(c) information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the licensed dealer has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use; or

(d) the continuation of the permit would likely create a risk to public health, safety or security, including the risk of a Class A precursor being diverted to an illicit market or use.

27. Section 46 of the Regulations is amended by striking out the word "or" at the end of paragraph (a) and by replacing paragraph (b) with the following:

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security; or

(c) the Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class A precursor being diverted to an illicit market or use.

28. Subsection 47(1) of the Regulations is replaced by the following:

47. (1) No licensed dealer may destroy a Class A precursor except in accordance with subsections (2) to (4).

29. The headings before section 48 of the Regulations are replaced by the following:

Preparations and Mixtures

Application for Authorization Certificate

30. (1) The portion of subsection 48(1) of the Regulations before paragraph (a) is replaced by the following:

48. (1) With respect to a Class A precursor that is a preparation or mixture, a person who produces or imports, or desires to do so, may apply for an authorization certificate with respect to the preparation or mixture by submitting an application to the Minister containing the following information and statements:

(2) Subsection 48(1) of the Regulations is amended by adding the following after paragraph (b):

(b.1) if the applicant is not the producer of the preparation or mixture, the name of the person who produced the precursor or, if the person is a corporation, its corporate name;

(b.2) the address, telephone number and facsimile transmission number, if any, of the person who produced the preparation or mixture;

(3) Paragraphs 48(1)(d) and (e) of the Regulations are replaced by the following:

(d) a statement, by the person who produced the preparation or mixture, that the preparation or mixture is made in such a way that no precursors set out in Part 1 of Schedule VI to the Act can be readily extracted, having regard to the complexity and cost of extraction, and that the preparation or mixture cannot be used in the production of a controlled substance; and

(e) a statement, by the person who produced the preparation or mixture, justifying the application for the certificate, and identifying the scientific principles and any other information in support of the statement under paragraph (d).

(4) The portion of subsection 48(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

(2) La demande de certificat doit :

31. The heading before section 49 of the Regulations is replaced by the following:

Issuance of Authorization Certificate

32. (1) The portion of section 49 of the Regulations before paragraph (a) is replaced by the following:

49. (1) Subject to section 50, if an application complies with the requirements of section 48, the Minister shall issue to the applicant an authorization certificate that indicates

(2) Paragraph 49(1)(b) of the Regulations is replaced by the following:

(b) the name, if any, of the preparation or mixture that is the subject of the certificate, otherwise a description of its chemical composition, and its brand name, if any;

(3) Subsection 49(1) of the Regulations is amended by adding the following after paragraph (c):

(c.1) if the applicant is not the producer of the preparation or mixture, the name of the person who produced the precursor or, if the person is a corporation, its corporate name;

(4) Section 49 of the Regulations is amended by adding the following after subsection (1):

(2) The holder of an authorization certificate shall, on request, provide a copy of the certificate to any person conducting an activity in relation to the preparation or mixture to which the certificate applies.

33. Section 50 of the Regulations is replaced by the following:

50. The Minister shall refuse to issue an authorization certificate if, according to the information provided and scientific data or other information or evidence available, a precursor set out in Part 1 of Schedule VI to the Act can be readily extracted from the preparation or mixture that is the subject of the application, having regard to the complexity and cost of extraction, or the preparation or mixture can be used in the production of a controlled substance.

34. Sections 51 to 54 of the Regulations are replaced by the following:

51. A person who imports or exports a Class A precursor that is a preparation or mixture mentioned in an authorization certificate shall ensure that the shipment is accompanied by a document containing:

(a) a statement that the preparation or mixture is subject to an authorization certificate under section 49; and

(b) the certificate number for the preparation or mixture.

Revocation or Suspension of Certificate

52. The Minister shall revoke an authorization certificate at the request of the holder.

53. (1) The Minister shall, in accordance with subsection 84(1), revoke an authorization certificate if the certificate

(a) was issued on the basis of false or misleading information, or false or falsified documents; or

(b) has been the subject of a suspension under paragraph 54(a) and subsection 84(2) and the suspension has not been complied with.

(2) The Minister may revoke an authorization certificate if the holder fails to comply with a decision of the Minister to suspend the certificate under section 54, or if the situation giving rise to the suspension is not rectified.

54. The Minister shall, without prior notice, suspend an authorization certificate if

(a) new scientific evidence or other new information demonstrates that a precursor set out in Part 1 of Schedule VI to the Act can be readily extracted from the preparation or mixture mentioned in the certificate, having regard to the complexity and cost of extraction, or demonstrates that the preparation or mixture may be or has been used in the production of a controlled substance;

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security; or

(c) the Minister has reasonable grounds to suspect that the continuation of the certificate presents a risk of a Class A precursor being diverted to an illicit market or use.

35. Sections 55 and 56 of the Regulations are replaced by the following:

55. With respect to a Class B precursor that is a preparation or mixture, a person who conducts an activity mentioned in section 57 is exempt from the requirements of these Regulations, except requirements applying to production for the purpose of sale or provision, if the preparation or mixture contains a precursor set out in Part 2 of Schedule VI to the Act and the contained precursor, either alone or with any other precursor of the same type, does not constitute more than 30% of the preparation or mixture by weight or volume, in the case of a solid or liquid, respectively.

56. A person who uses a Class B precursor that is described in section 55 or is the subject of an authorization certificate under section 77, to produce another Class B precursor that is a preparation or mixture, is exempt from the requirements of these Regulations in respect of that production.

36. The Regulations are amended by adding the following after section 57:

Authorization Concerning Preparations and Mixtures

57.1 Despite section 57, with respect to a Class B precursor that is a preparation or mixture, a person may import, export or possess for those purposes if

(a) the preparation or mixture is the subject of an authorization certificate under section 77; and

(b) no notice indicating that the certificate has been revoked or is under suspension appears on the following Health Canada Internet site:

http://www.hc-sc.gc.ca/dhp-mps/substancontrol/index_e.html

37. (1) Paragraph 63(1)(b) of the Regulations is replaced by the following:

(b) the Minister has reasonable grounds to believe that any information or document included in the application is false or misleading;

(2) Paragraph 63(1)(e) of the Regulations is replaced by the following:

(e) information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the applicant has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use;

38. Paragraph 67(1)(e) of the Regulations is replaced by the following:

(e) information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the registered dealer has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use;

(e.1) the continuation of the registration would likely create a risk to public health, safety or security, including the risk of a Class B precursor being diverted to an illicit market or use; or

39. Section 68 of the Regulations is replaced by the following:

68. The Minister shall suspend a registration and the corresponding certificate without prior notice if the Minister has reasonable grounds

(a) to believe that the suspension is necessary to protect public health, safety or security; or

(b) to suspect that the continuation of the registration and the certificate presents a risk of a Class B precursor being diverted to an illicit market or use.

40. (1) Subparagraph 69(1)(c)(i) of the Regulations is replaced by the following:

(2) Paragraph 69(1)(e) of the Regulations is replaced by the following:

(e) the proposed means of transportation;

(e.1) the name of any proposed country of transit or transhipment;

(3) Paragraph 69(1)(g) of the Regulations is replaced by the following:

(g) the proposed port of exit from Canada;

(4) Paragraph 69(1)(i) of the Regulations is replaced by the following:

(i) the name and address of the proposed customs broker for the registered dealer, if any;

41. The Regulations are amended by adding the following after section 72:

Declaration

72.1 (1) Within 15 days after a shipment containing a Class B precursor is exported, the holder of a Class B export permit for the shipment shall provide the Minister with a declaration containing the following information:

(a) the name of the holder and permit number for the shipment;

(b) the port of exit from Canada for the shipment;

(c) the date of export;

(d) the name of the precursor being shipped or a description of its chemical composition, as stated in the permit; and

(e) the quantity of the precursor being shipped and, if it is a preparation or mixture, the quantity of all precursors set out in Part 2 of Schedule VI to the Act that it contains.

(2) The declaration must

(a) be signed by the senior person in charge designated by the registered dealer; and

(b) include a statement that all information set out in the declaration is correct and complete to the best of the knowledge of the signatory.

42. Subsection 74(1) of the Regulations is replaced by the following:

74. (1) Subject to subsection (2), the Minister shall revoke a Class B export permit in accordance with subsection 84(1) if

(a) a circumstance described in any of paragraphs 67(1)(a) to (f) exists with respect to the registration of the holder of the permit; or

(b) the export permit was issued on the basis of false or misleading information or false or falsified documents.

43. Paragraph 75(b) of the Regulations is replaced by the following:

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;

(b.1) the Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class B precursor being diverted to an illicit market or use;

44. The headings before section 76 of the Regulations are replaced by the following:

Preparations and Mixtures

Application for Authorization Certificate

45. (1) The portion of subsection 76(1) of the Regulations before paragraph (a) is replaced by the following:

76. (1) With respect to a Class B precursor that is a preparation or mixture, a person who produces for the purpose of sale or provision, or imports, or desires to do either, may apply for an authorization certificate for the preparation or mixture, by submitting an application to the Minister containing the following information and statements:

(2) Subsection 76(1) of the Regulations is amended by adding the following after paragraph (b):

(b.1) if the person is not the producer of the preparation or mixture, the name of the producer or, if the producer is a corporation, its corporate name;

(b.2) the address and the telephone number and facsimile transmission number, if any, of the producer of the preparation or mixture;

(3) Paragraphs 76(1)(d) and (e) of the Regulations are replaced by the following:

(d) a statement, by the producer of the preparation or mixture, that the preparation or mixture is made in such a way that no precursor set out in Part 2 of Schedule VI to the Act contained in it can be readily extracted, having regard to the complexity and cost of extraction, and that the preparation or mixture cannot be used in the production of a controlled substance; and

(e) a statement, by the producer of the preparation or mixture, justifying the application for the certificate, and identifying the scientific principles and any other information in support of the statement under paragraph (d).

(4) The portion of subsection 76(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

(2) La demande de certificat doit :

(5) Subparagraph 76(2)(a)(i) of the English version of the Regulations is replaced by the following:

46. The heading before section 77 of the Regulations is replaced by the following:

Issuance of Authorization Certificate

47. (1) The portion of section 77 of the Regulations before paragraph (a) is replaced by the following:

77. (1) Subject to section 78, if an application complies with the requirements of section 76, the Minister shall issue to the applicant an authorization certificate that indicates

(2) Paragraph 77(1)(b) of the Regulations is replaced by the following:

(b) the name, if any, of the preparation or mixture that is the subject of the certificate, otherwise a description of its chemical composition, and its brand name, if any;

(3) Section 77 of the Regulations is amended by adding the following after subsection (1):

(2) The holder of an authorization certificate shall, on request, provide a copy of the certificate to any person conducting an activity in relation to the preparation or mixture to which the certificate applies.

48. Section 78 of the Regulations is replaced by the following:

78. The Minister shall refuse to issue an authorization certificate if, according to the information provided and scientific data or other information or evidence available, a precursor set out in Part 2 of Schedule VI to the Act can be readily extracted from the preparation or mixture that is the subject of the application, having regard to the complexity and cost of extraction, or the preparation or mixture can be used in the production of a controlled substance.

49. Sections 79 to 82 of the Regulations are replaced by the following:

79. A person who exports a preparation or mixture mentioned in an authorization certificate shall ensure that the shipment is accompanied by a document containing:

(a) a statement that the preparation or mixture is subject to an authorization certificate under section 77; and

(b) the certificate number for the preparation or mixture.

Revocation and Suspension

80. The Minister shall revoke an authorization certificate at the request of the holder.

81. (1) The Minister shall, in accordance with subsection 84(1), revoke an authorization certificate if the certificate

(a) was issued on the basis of false or misleading information, or false or falsified documents; or

(b) has been the subject of a suspension under paragraph 82(a) and subsection 84(2) and the suspension has not been complied with.

(2) The Minister may revoke an authorization certificate if the holder fails to comply with a decision of the Minister to suspend the certificate under section 82, or if the situation giving rise to the suspension is not rectified.

82. The Minister shall, without prior notice, suspend an authorization certificate if

(a) new scientific evidence or other new information demonstrates that a precursor set out in Part 2 of Schedule VI to the Act can be readily extracted from the preparation or mixture mentioned in the certificate, having regard to the complexity and cost of extraction, or demonstrates that the preparation or mixture may be or has been used in the production of a controlled substance;

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security; or

(c) the Minister has reasonable grounds to suspect that the continuation of the authorization certificate presents a risk of a Class B precursor being diverted to an illicit market or use.

50. (1) The portion of subsection 84(1) of the Regulations before paragraph (a) is replaced by the following:

84. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a licence, a registration and the corresponding registration certificate, an authorization certificate, an import or export permit or a permit for transit or transhipment, issued under these Regulations, the Minister shall provide the applicant or the holder with

(2) Subsection 84(2) of the Regulations is replaced by the following:

(2) A decision of the Minister to suspend a licence, a registration and the corresponding registration certificate, an authorization certificate, an import or export permit or a permit for transit or transhipment, issued under these Regulations, takes effect as soon as the Minister notifies the holder of the decision and provides a written report of the reasons for the suspension.

51. Subsection 85(3) of the French version of the Regulations is replaced by the following:

(3) Le distributeur autorisé tient, à l'installation visée par la licence, un registre où sont consignés, chaque jour où une personne accède, à l'installation, à un lieu où sont conservés des précurseurs de catégorie A, le nom de cette personne ainsi que la date de son accès à ce lieu.

52. The Regulations are amended by adding the following after section 85:

85.1 If a licence expires without being renewed or is revoked the former licensed dealer shall,

(a) retain the records and information that they were required to keep or make under sections 85 and 86 for at least two years after the expiry or revocation; and

(b) at the written request of the Minister, provide the Minister with a copy of any record or document required to be kept under paragraph (a).

53. Section 87 of the Regulations is amended by striking out the word "and" at the end of paragraph (a) and by replacing paragraph (b) with the following:

(b) the quantity of each Class A precursor in physical inventory taken at the site at the end of the calendar year; and

(c) the name and quantity of any Class A precursor that has been lost or wasted in the course of conducting authorized activities during the calendar year.

54. The Regulations are amended by adding the following after section 87:

87.1 (1) If a licence expires without being renewed or is revoked and the expiry or revocation occurs within the first three months of a calendar year, the former licensed dealer shall

(a) in respect of the portion of the three calendar months during which the licence was valid, make the report to the Minister referred to in section 87 within three months after the expiry or revocation; and

(b) in respect of the preceding calendar year, make the report to the Minister referred to in section 87 within three months after the end of that calendar year.

(2) If a licence expires without being renewed or is revoked and the expiry or revocation occurs after the first three months of the calendar year, the licensed dealer shall, in respect of the portion of the calendar year during which the licence was valid, make the report, referred to in section 87, to the Minister within three months after the expiry or revocation.

(3) For the purpose of paragraph (1)(a) and subsection (2), the information to be furnished is that pertaining to operations for the portion of the calendar year during which the licence was valid and pertaining to the quantity in physical inventory on the date of expiry or revocation.

Notice of Precursor Removal

87.2 If a licensed dealer or registered dealer intends to close a site at which one or more precursors are kept, or to remove all precursors from the site, the dealer shall, at least 30 days before the closure or removal, notify the Minister in writing of

(a) the date of the intended closure or removal;

(b) the site to which the precursors will be moved; and

(c) the quantity of each precursor to be moved.

55. Subsection 89(1) of the Regulations is replaced by the following:

89. (1) If a licence or a registration or authorization certificate is renewed, the holder shall, as soon as possible after the effective date of the replacing document, return the replaced document to the Minister.

56. (1) The portion of subsection 90(2) of the Regulations before paragraph (a) is replaced by the following:

(2) If a licensed dealer or registered dealer experiences a theft of a precursor or an unusual waste or disappearance of a precursor that cannot be explained on the basis of normally accepted business activities, the licensed dealer or registered dealer

(2) Section 90 of the Regulations is amended by adding the following after subsection (2):

(3) If a licence, a registration or authorization certificate, an import or export permit or a permit for transit or transhipment issued under these Regulations is lost or stolen, the holder of the document shall provide notice of the occurrence to the Minister, in writing, within 24 hours after becoming aware of the occurrence.

57. (1) Paragraph 91(1)(g) of the Regulations is replaced by the following:

(g) the port of entry into or exit from Canada mentioned in the permit;

(2) Paragraph 91(1)(k) of the Regulations is replaced by the following:

(k) the name and address of the proposed customs broker involved, if any;

(3) Paragraph 91(3)(g) of the Regulations is replaced by the following:

(g) the proposed ports of entry into and exit from Canada;

(4) The portion of subsection 91(4) of the Regulations before paragraph (a) is replaced by the following:

(4) The Minister may, for the purpose of verifying whether a precursor that is a preparation or mixture is the subject of an authorization certificate under these Regulations and may be imported, exported, transported in transit through Canada or transhipped in Canada without the appropriate permit under these Regulations, communicate the following information to a customs officer in Canada:

(5) Paragraphs 91(4)(b) and (c) of the Regulations are replaced by the following:

(b) the name of the preparation or mixture, if any, otherwise a description of its chemical composition, and its brand name, if any;

(c) the name of the person who applied for the authorization certificate, or, if the applicant is a corporation, its corporate name;

(6) Subsection 91(6) of the Regulations is replaced by the following:

(6) The Minister is authorized to receive, for the purpose of the administration of these Regulations, information provided by the INCB, a competent authority, the United Nations or a peace officer.

58. The Regulations are amended by adding the following after section 91:

PART 4

PHARMACISTS, PRACTITIONERS AND HOSPITALS

Non-application

91.1 With respect to a Class A precursor, the requirements of paragraph 6(1)(c) and subsections 6(2) and 9(1) concerning sale or provision, possession for the purpose of sale or provision and transport do not apply to a pharmacist, practitioner or hospital that sells or provides preparations or mixtures containing Class A precursors only on a retail basis.

Pharmacists

Activities Authorized Under a Prescription

91.2 A pharmacist may, pursuant to a prescription, compound a preparation or mixture using a precursor.

91.3 (1) A pharmacist may sell or provide a preparation or mixture that contains a Class A precursor set out in column 1 of the schedule, in a quantity, per transaction, exceeding the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule, if the pharmacist sells or provides preparations or mixtures containing Class A precursors exclusively on a retail basis and the transaction is made under a prescription.

(2) The prescription must be

(a) written, dated and signed by the practitioner who issued it;

(b) provided verbally by a practitioner; or

(c) transferred to the pharmacist in accordance with the requirements of section 91.7.

Information to Be Recorded

91.4 (1) A pharmacist who receives a verbal prescription for a preparation or mixture containing a Class A precursor must, before filling it, record the following information:

(a) the name and address of the individual or owner of the animal for whose benefit the prescription is provided;

(b) the date on which the prescription was provided;

(c) the name and quantity of the preparation or mixture specified in the prescription;

(d) the name of the recording pharmacist and the name of the practitioner who issued the prescription;

(e) the directions for use specified by the practitioner; and

(f) if the prescription is to be refilled, the number of times it may be refilled and, if applicable, the interval between refills.

(2) The pharmacist must retain, in accordance with section 91.95, a hard copy of the prescription or a written record of it.

91.5 (1) Subject to section 91.6, a pharmacist who fills a written or verbal prescription for a preparation or mixture containing a Class A precursor must record the following information:

(a) the date the prescription was filled;

(b) the quantity of the preparation or mixture provided when the prescription was filled;

(c) the pharmacist's name or initials; and

(d) the number assigned to the prescription.

(2) A pharmacist who fills a written prescription shall retain the prescription in accordance with section 91.95.

Refill of Prescription

91.6 A pharmacist may only refill a prescription for a preparation or mixture containing a Class A precursor if

(a) the practitioner who issued the prescription expressly directs that it may be refilled and specifies the number of refills;

(b) the pharmacist makes a record of each refill in accordance with subsection 91.5(1), with any modifications that the circumstances require;

(c) at least one refill remains on the prescription; and

(d) if an interval between refills has been specified by the practitioner, the interval has expired.

Transfer of Prescription

91.7 (1) A pharmacist may transfer a prescription for a preparation or mixture containing a Class A precursor to another pharmacist or to a hospital.

(2) Before a pharmacist sells or provides a preparation or mixture containing a Class A precursor to an individual under a prescription that is transferred under subsection (1), the pharmacist shall

(a) in the case of a verbal transfer, record the information required by subsection 91.4(1);

(b) in the case of a written transfer, obtain from the transferring pharmacist a copy of

(c) in all cases, record

Practitioners

91.8 A practitioner may, with respect to a preparation or mixture containing a Class A precursor, prescribe it for or administer it to an individual or animal, or sell or provide it to or for an individual or for the benefit of an animal, only if

(a) the individual or animal is being treated by the practitioner in their professional capacity; and

(b) the preparation or mixture is required to treat the individual's or animal's medical condition.

91.9 A practitioner who sells or provides a preparation or mixture containing a Class A precursor set out in column 1 of the schedule to an individual for self-administration or administration to an animal in a quantity that exceeds the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule, may do so only if the transaction is made under a prescription and shall make a record of the following information:

(a) the name and quantity of the preparation or mixture;

(b) the name and address of the person to whom the preparation or mixture was provided; and

(c) the date on which the preparation or mixture was provided.

Hospitals

91.91 A hospital that sells or provides a preparation or mixture containing a Class A precursor exclusively on a retail basis may do so subject to sections 91.92 to 91.94.

91.92 (1) The person in charge of a hospital shall not permit a preparation or mixture containing a Class A precursor set out in column 1 of the schedule to be sold or provided to a patient or for the benefit of an animal under treatment as an in-patient or an out-patient of the hospital in a quantity, per transaction, that exceeds the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule, unless the transaction is made under a prescription or another authorization of a practitioner practising in the hospital.

(2) The person in charge of the hospital shall keep the following information or ensure that it is kept:

(a) the name and quantity of the preparation or mixture provided when the prescription was filled;

(b) the name and address of the person for whom the prescription was issued;

(c) the date on which the prescription was filled; and

(d) the number assigned to the prescription.

91.93 The person in charge of a hospital shall not permit a prescription for a preparation or mixture containing a Class A precursor to be refilled at the hospital unless the requirements of section 91.6 are satisfied, with any modifications that the circumstances require.

91.94 The person in charge of a hospital shall not permit a preparation or mixture containing a Class A precursor to be sold or provided pursuant to a prescription that has been transferred to the hospital, unless the requirements of subsection 91.7(2) are satisfied, with any modifications that the circumstances require.

91.95 Information to be recorded and records to be kept under this Part shall be retained for at least two years after the date the information was obtained or the record was made.

Security Measures and Communication of Information

91.96 A pharmacist, practitioner or hospital that sells or provides only on a retail basis, or possesses for the purpose of sale or provision, preparations or mixtures containing Class A precursors, shall

(a) take reasonable steps to ensure the security of the Class A precursors;

(b) on discovering an unusual waste or disappearance of a Class A precursor that cannot be explained on the basis of normally accepted business practices, notify

(c) on discovering a theft of a Class A precursor set out in column 1 of the schedule, if the package in which it is contained is not intended for retail sale and contains a quantity of the precursor exceeding the maximum quantity specified for the precursor in column 2 of the schedule, notify the persons mentioned in subparagraphs (b)(i) and (ii) within the applicable time-periods; and

(d) on request, provide to the Minister or make available for examination by the Minister, any information or record required to be kept or made under this Part.

59. The Schedule to the Regulations is amended by replacing the reference "(Sections 5, 8 and 92)" after the heading "SCHEDULE" with the reference "(Sections 5, 8, 9, 91.3, 91.9, 91.92 and 92)".

60. The schedule to the Regulations is amended by adding the following after item 18:

Item	Column 1 Precursor set out in Part 1 of Schedule VI to the Act	Column 2 Maximum Quantity (expressed as an absolute amount or per package)
19.	Gamma-butyrolactone (dihydro-2(3H)-furanone)	0
20.	1,4-butanediol	0
21.	Red Phosphorus	0
22.	White Phosphorus	0
23.	Hypophosphorous acid, its salts and derivatives	0
24.	Hydriodic acid	0

61. The Regulations are amended by replacing the words "registration or exemption certificate" with the words "registration or authorization certificate" wherever they occur in the following provisions:

(a) section 88;

(b) subsection 89(2);

(c) subsection 90(1); and

(d) paragraph 91(5)(a).

COMING INTO FORCE

62. (1) Subject to subsection (2), these Regulations come into force on the day on which they are registered.

(2) Section 60 of these Regulations comes into force on January 31, 2006.

N.B. The Regulatory Impact Analysis Statement for these Regulations appears following SOR/2005-364, Order Amending Schedule VI to the Controlled Drugs and Substances Act.

Footnote a

S.C. 1996, c. 19

Footnote 1

SOR/2002-359

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