Food and Drug Regulations

C.10.005 (1) Subject to subsection (3), the Minister may add a drug that is fabricated outside Canada to Subpart 1 or 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale only if

• (a) either of the following conditions is met in respect of another drug:

  • (i) the Minister has reasonable grounds to believe that there is a shortage or risk of shortage of the other drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and not been cancelled, or

  • (ii) the sale of the other drug was discontinued;

• (b) the Minister has reasonable grounds to believe that

  • (i) a shortage of the other drug if it were to occur, or the discontinuation of sale of it could present a risk of injury to human health,

  • (ii) the drug to be added to that list can be substituted for the other drug, and

  • (iii) the drug to be added to that list is authorized to be sold by a foreign regulatory authority within its jurisdiction; and

• (c) in the case referred to in subparagraph (a)(ii), the drug to be added to that list is added on or before the day that is 36 months after the day on which the sale of the other drug was discontinued.

(2) Subject to subsection (3), the Minister may add a lot or batch of a drug that is fabricated in Canada to Subpart 1 or 2 of Part 2 of the List of Drugs for Exceptional Importation and Sale only if

• (a) either of the following conditions is met in respect of another drug:

  • (i) the Minister has reasonable grounds to believe that there is a shortage or risk of shortage of the other drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and not been cancelled, or

  • (ii) the sale of the other drug was discontinued; and

• (b) the Minister has reasonable grounds to believe that

  • (i) a shortage of the other drug, if it were to occur, or the discontinuation of sale of it could present a risk of injury to human health, and

  • (ii) the lot or batch of the drug to be added to that list meets the following conditions:

    • (A) it can be substituted for the other drug,

    • (B) it is authorized to be sold by a foreign regulatory authority within its jurisdiction,

    • (C) it is fabricated for consumption or use outside Canada, and

    • (D) despite clause (C), it is no longer intended for export.

(3) The Minister may add a drug to Subpart 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale — or a lot or batch of a drug to Subpart 2 of Part 2 of that list — only if

• (a) the drug is for human use;

• (b) the drug is not one of the following drugs:

  • (i) a drug included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act,

  • (ii) a prescription drug,

  • (iii) a drug listed in Schedule C or D to the Act, or

  • (iv) a drug that is permitted to be sold without a prescription but that is to be administered only under the supervision of a practitioner; and

• (c) the Minister has reasonable grounds to believe that use of the drug can cause injury to human health or present a risk to public health and the injury or risk can be mitigated by the supervision of a practitioner or pharmacist.