Food and Drug Regulations (C.R.C., c. 870)

C.10.007.2 Despite sections C.01.003, C.01.014 and C.08.002, the fabricator of a designated drug who is neither the distributor of the drug for consumption or use outside Canada nor a wholesaler of the drug may sell the drug for consumption or use in Canada only to that distributor or such a wholesaler.

C.10.007.3 Paragraph C.02.018(3)(c) does not apply to a person who holds an establishment licence in respect of a designated drug that they sell under subsection C.10.007.1(1) or section C.10.007.2.

• C.10.007.4 (1) Subject to subsection (2), sections C.10.008 to C.10.013 apply in respect of

  • (a) a designated drug that is imported under section C.10.006; and

  • (b) a designated drug that is sold under subsection C.10.007.1(1) or section C.10.007.2.

• (2) Sections C.10.009 and C.10.010 do not apply in respect of a designated drug referred to in paragraph (1)(b).

• C.10.008 (1) Subject to subsection (3) and sections C.10.007.3, C.10.009, C.10.010 and C.10.010.2, a sale of a designated drug is exempt from the following provisions:

  • (a) sections A.01.014 to A.01.017 and A.01.051; and

  • (b) the provisions of Part C other than

    • (i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1 and C.01.040.3 to C.01.051.1,

    • (ii) the provisions of Divisions 1A and 2, and

    • (iii) sections C.10.007.1 to C.10.013.

• (2) For greater certainty, for the purposes of section C.01.016, the manufacturer of a designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 in respect of the drug.

• (3) Subsections (1) and (2) cease to apply in respect of the sale of a designated drug on its expiration date.

• C.10.009 (1) This section applies — but paragraph C.02.018(3)(c) and section C.02.019 do not apply — to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.

• (2) The licensee shall perform the finished product testing on a sample of the designated drug that is taken either

  • (a) after receipt of each lot or batch of the designated drug on their premises in Canada; or

  • (b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met:

    • (i) the licensee has evidence that the Minister considers satisfactory, in the interests of the health of the consumer or purchaser, to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug,

    • (i.1) the licensee undertakes periodic complete confirmatory testing, with a frequency that the Minister considers satisfactory, in the interests of the health of the consumer or purchaser, and

    • (ii) the designated drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

• (3) The licensee shall possess or have immediate access to the specifications for the designated drug until at least the latest expiration date of the designated drug.

• (4) If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product.

• (5) Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met:

  • (a) the address of the building is set out in their establishment licence; and

  • (b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch.

• (6) [Repealed, SOR/2026-96, s. 20]

• C.10.010 (1) A person who holds an establishment license and who imports a designated drug under section C.10.006 is required to comply with paragraphs C.02.020(1)(a), (b) and (d) in respect of the drug but is not required to maintain the records referred to in those paragraphs on their premises in Canada.

• (2) The Minister may request that the licensee provide to the Minister any of the records referred to in paragraphs C.02.020(1)(a), (b) or (d) in respect of the designated drug.

• (3) The licensee shall provide the requested records in the time, form and manner specified by the Minister.

C.10.010.1 A person who holds an establishment licence and imports a designated drug under section C.10.006 — or a person who holds an establishment licence and sells a designated drug under subsection C.10.007.1(1) and is not the manufacturer of the drug — shall submit to the Minister, in the form and manner specified by the Minister, a report of all information relating to the following serious adverse drug reactions within 15 days after the day on which they receive or become aware of the information, whichever occurs first:

• (a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and

• (b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug.

• C.10.010.2 (1) Despite subsection C.01.050(4), section C.01.050 applies — in respect of a designated drug — to a person who holds an establishment licence and imports the drug under section C.10.006 or a person who holds an establishment licence and sells the drug under subsection C.10.007.1(1), with any necessary modifications.

• (2) A reference to a foreign regulatory authority in the applicable paragraph of subsection C.01.050(2) includes a reference to the foreign regulatory authority referred to in subparagraph C.10.006(1)(d)(iii) or C.10.007.1(2)(c)(iii), as the case may be, if that foreign regulatory authority is not set out in any of Parts A to C of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time.

C.10.010.3 A drug that is removed from the List of Drugs for Exceptional Importation and Sale before the date referred to in subsection C.10.011(2) continues to be considered a designated drug for the purposes of sections C.10.010.1, C.10.010.2 and C.10.011 until that date.

• C.10.010.4 (1) No person shall sell on a retail basis a designated drug that is set out in Subpart 1 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale unless the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French to the purchaser or consumer in any of the following manners:

  • (a) the information accompanies the drug;

  • (b) the information is provided in writing to the purchaser or consumer at the time of sale;

  • (c) in the case where the drug is accessible to the public for self-selection, copies of the information are placed adjacent to the drug in a manner that permits the purchaser or consumer to take one.

• (2) For the purposes of subsection (1), the English and French versions of the information referred to in clause C.10.006(1)(a)(iii)(G) need not be available in the same manner.

• (3) Subsection (1) does not apply to the sale of a designated drug that is set out in Subpart 1 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale by a pharmacist under a prescription, or by a practitioner.

• C.10.011 (1) A person who holds an establishment licence shall not sell a designated drug that they imported under section C.10.006 unless they ensure that the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French and in a manner that permits the safe use of the drug.

• (2) The licensee shall ensure that the information is available in accordance with subsection (1) until at least the latest expiration date of the designated drug that they imported.

C.10.012 A person who holds an establishment licence in respect of a drug shall not sell a designated drug set out in Subpart 2 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale except to a practitioner, a pharmacist, a hospital as defined in subsection C.01.020.1(4) or another person who holds an establishment licence in respect of a drug.

C.10.013 A pharmacist or a person working under a pharmacist’s supervision shall not sell a designated drug set out in Subpart 2 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale on a retail basis unless the drug is not accessible to the public for self-selection.

Extended Expiration Dates

C.10.014 The following definitions apply in this section and in sections C.10.015 to C.10.021.

extended expiration date

extended expiration date means, in respect of a specified lot or batch, the date set out in column 2 of the List of Drugs with Extended Expiration Dates. (date limite d’utilisation reportée)

List of Drugs with Extended Expiration Dates

List of Drugs with Extended Expiration Dates means the List of Drugs with Extended Expiration Dates that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues dont la date limite d’utilisation est reportée)

specified lot or batch

specified lot or batch means a lot or batch of a drug set out in column 1 of the List of Drugs with Extended Expiration Dates. (lot ou lot de fabrication inscrit)

• C.10.015 (1) The Minister may add a lot or batch of a drug to column 1 of the List of Drugs with Extended Expiration Dates and a date to column 2 of that list in relation to the lot or batch only if

  • (a) a drug identification number has been assigned to the drug under subsection C.01.014.2(1) and not been cancelled; and

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

    • (i) there is a shortage or risk of shortage of the drug,

    • (ii) a shortage of the drug, if it were to occur, could present a risk of injury to human health, and

    • (iii) the lot or batch will comply with the specifications for that drug until at least the date to be added to column 2.

• (2) In subsection (1), specifications has the same meaning as in section C.02.002.

C.10.016 Sections C.10.017 to C.10.021 apply in respect of a specified lot or batch and its extended expiration date if the following information is also set out in the List of Drugs with Extended Expiration Dates:

• (a) the drug’s brand name;

• (b) the drug identification number assigned to the drug;

• (c) the name of the manufacturer of the drug;

• (d) the expiration date of the lot or batch; and

• (e) the date on which the Minister added the lot or batch to that list.

C.10.017 Despite the definition expiration date in subsection C.01.001(1), a reference to an expiration date in the provisions of this Part — other than paragraph C.10.016(d) — is, in respect of a specified lot or batch, a reference to its extended expiration date.

C.10.018 Subparagraphs C.01.004(1)(c)(v) and (3)(b)(vii), paragraph C.04.009(2)(e) and subparagraph C.04.009(6)(a)(ix) do not apply in respect of a specified lot or batch.

C.10.019 Sections C.01.014 and C.08.003 do not apply in respect of a specified lot or batch if its extended expiration date is the only change in respect of the lot or batch that relates to the information previously provided to the Minister in connection with the drug.

• C.10.020 (1) Within five days after the day on which a specified lot or batch is added to the List of Drugs with Extended Expiration Dates, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall notify any person who holds an establishment licence and to whom they sold the lot or batch of its extended expiration date.

• (2) Any person who holds an establishment licence, who has sold a specified lot or batch and who is notified of its extended expiration date shall, within five days after the day on which they are notified, notify any other person to whom they sold the lot or batch of that date.

C.10.021 No person shall sell a specified lot or batch after its extended expiration date.

DIVISION 11Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling

• C.11.001 (1) The following definitions apply in this Division.

  foreign regulatory authority

  foreign regulatory authority has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère)

  initial public health official

  initial public health official means the public health official named in an authorization issued under subsection C.11.003(1). (responsable de la santé publique initial)

  public health official

  public health official means

  • (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;

  • (b) the Chief Medical Officer of Health, or equivalent, of a province;

  • (c) the Medical Officer of Health, or equivalent, of a municipality;

  • (d) the Surgeon General of the Canadian Armed Forces; or

  • (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)

  subsequent public health official

  subsequent public health official means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). (responsable de la santé publique subséquent)

• (2) This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, including drugs that have ceased to be considered to be natural health products by virtue of subsection 103.15(2) of the Natural Health Products Regulations.