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

Regulations are current to 2022-05-02 and last amended on 2022-03-02. Previous Versions

PART CDrugs (continued)

DIVISION 9 (continued)

Acetaminophen (continued)

  •  (1) Subject to subsections (2) to (4), an acetaminophen product sold in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of acetaminophen per individual dosage form.

  • (2) An acetaminophen product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain 500 mg of acetaminophen per individual dosage form if it has a label that states that it is not a standard dosage unit product.

  • (3) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration may contain 325 mg of acetaminophen for immediate release and another 325 mg for subsequent release, if it has a label that states that it is not a standard dosage unit product.

  • (4) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per individual dosage form.

  • (5) An acetaminophen product in the form of a liquid that is intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per millilitre of the product.

  • (6) A package of an acetaminophen product described in subsection (5) shall be accompanied by a measuring device capable of accurately delivering 0.5 mL of the product.

  • (7) An acetaminophen product in the form of a liquid that is not intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit per teaspoon of the product.

  • (8) An acetaminophen product in the form of a liquid shall contain one adult standard dosage unit of acetaminophen per teaspoon of the product.

  • SOR/84-145, s. 4
  • SOR/85-966, s. 4
  • SOR/86-954, s. 1
  • SOR/99-441, s. 1

Salicylates

  •  (1) The adult standard dosage unit of a salicylate shall be

    • (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 325 mg; and

    • (b) in the case of choline salicylate, 435 mg.

  • (2) The children’s standard dosage unit of a salicylate shall be

    • (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 80 mg; and

    • (b) in the case of choline salicylate, 110 mg.

  • SOR/84-145, s. 4
  •  (1) In this Division, salicylate product means a drug that contains

    • (a) a salt or derivative of salicylic acid as a single medicinal ingredient;

    • (b) a salt or derivative of salicylic acid in combination with caffeine;

    • (c) a salt or derivative of salicylic acid in combination with one or more buffering agents or antacids; or

    • (d) a salt or derivative of salicylic acid in combination with caffeine and one or more buffering agents or antacids.

  • (2) No manufacturer or importer shall sell a salicylate product after June 30, 1986 unless it meets the requirements of this Division.

  • (3) No manufacturer or importer shall, until June 30, 1986, sell a salicylate product in a dosage unit other than one mentioned in this Division, unless the salicylate product was legally available for sale in Canada on February 1, 1984.

  • SOR/84-145, s. 4
  • SOR/85-966, s. 5(E)
  •  (1) Subject to subsections (2) and (3) and section C.09.035, a salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of a salicylate per individual dosage form.

  • (2) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

    • (a) 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate, or

    • (b) 670 mg of choline salicylate

    per individual dosage form if it has a label that states that it is not a standard dosage unit product.

  • (3) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

    • (a) two adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains two adult standard dosage units; and

    • (b) three adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains three adult standard dosage units.

  • SOR/84-145, s. 4
  • SOR/85-966, s. 6
  •  (1) Subject to subsection (2), a salicylate product in the form of a liquid shall contain one adult standard dosage unit of a salicylate per teaspoon.

  • (2) A salicylate product in the form of a liquid may contain

    • (a) two adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains two adult standard dosage units; and

    • (b) three adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains three adult standard dosage units.

  • SOR/84-145, s. 4

 A salicylate product that is claimed to be buffered shall provide at least 1.9 milliequivalents of acid neutralizing capacity per adult standard dosage unit of a salicylate.

  • SOR/84-145, s. 4

 A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of a salicylate per individual dosage form.

  • SOR/84-145, s. 4

DIVISION 10Access to Drugs in Exceptional Circumstances

  •  (1) The following definitions apply in this section.

    foreign regulatory authority

    foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction. (autorité réglementaire étrangère)

    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 Surgeon General of the Canadian Armed Forces; or

    • (d) the Chief Medical Officer of Public Health for the First Nations and Inuit Health Branch of the Department of Health. (responsable de la santé publique)

  • (2) Despite sections A.01.040 and C.01.004.1, any person who holds an establishment licence that authorizes the importation of a drug may import a drug for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, or for which a drug identification number has not been assigned under subsection C.01.014.2(1), if the following conditions are met:

    • (a) a public health official has, within the past year, notified the Minister in writing of

      • (i) an urgent public health need for the immediate use of the drug within their jurisdiction, and

      • (ii) the intended use or purpose of the drug;

    • (b) the drug is authorized by a foreign regulatory authority in the United States, Switzerland or the European Union to be sold for the same use or purpose as that described under subparagraph (a)(ii);

    • (c) the drug is in the same category as the category for which the licence was issued;

    • (d) the drug is imported directly from the country in which it is authorized to be sold by the foreign regulatory authority; and

    • (e) the drug is one for which the following information is set out in the List of Drugs for an Urgent Public Health Need that is published by the Government of Canada on its website, as amended from time to time:

      • (i) brand name,

      • (ii) medicinal ingredients,

      • (iii) dosage form,

      • (iv) strength,

      • (v) route of administration, and

      • (vi) identifying code or number, if any, assigned in the country in which the drug was authorized for sale.

  • (3) Sections C.01A.006 and C.01A.007 do not apply in respect of the importation of a drug under subsection (2).

  • (4) For greater certainty, a licensee may, despite subsection C.01A.004(1), import a drug under subsection (2) without having their licence amended under section C.01A.006.

  • (5) Divisions 2 to 4, other than the following provisions, do not apply to the importation of a drug under subsection (2):

    • (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee;

    • (b) section C.02.006;

    • (c) subsection C.02.012(1);

    • (d) sections C.02.013 and C.02.014;

    • (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee;

    • (f) subsection C.02.021(1) as it applies to the storage of the drug by the licensee;

    • (g) subsection C.02.022(1);

    • (h) section C.02.023;

    • (i) subsections C.02.024(1) and C.02.025(1);

    • (j) section C.03.013; and

    • (k) section C.04.001.1 as it applies to the storage of the drug by the licensee.

  • SOR/2017-133, s. 2
  •  (1) A sale of a drug that is imported under subsection C.10.001(2) is exempt from the provisions of these Regulations only if the drug is sold, within the jurisdiction of a public health official who has notified the Minister as described in paragraph C.10.001(2)(a), for use in respect of the same urgent public health need for which it was imported.

  • (2) Any person who wholesales such a drug must hold an establishment licence to wholesale a drug in the same category and despite subsection (1), the following provisions apply in respect of the wholesale:

    • (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee;

    • (b) section C.02.006 as it applies to the storage of the drug by the licensee;

    • (c) subsection C.02.012(1);

    • (d) section C.02.013;

    • (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee;

    • (f) subsection C.02.022(1);

    • (g) section C.02.023; and

    • (h) subsection C.02.024(1).

  • SOR/2017-133, s. 2

 Every licensee who imports a drug under subsection C.10.001(2) must notify the Minister within 15 days after the day on which it is imported by providing the following information:

  • (a) the name, title and contact information of the person who imported the drug;

  • (b) the brand name of the drug;

  • (c) the medicinal ingredients, strength, dosage form, route of administration and the identifying code or number, if any assigned in the country in which the drug was authorized for sale;

  • (d) the name of the country from which the drug was imported; and

  • (e) the total quantity of the drug imported.

  • SOR/2017-133, s. 2
  •  (1) The following definitions apply in this section and in sections C.10.005 to C.10.011.

    designated drug

    designated drug means a drug that is set out in the List of Drugs for Exceptional Importation and Sale. (drogue désignée)

    drug

    drug means any of the following drugs for human use:

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

    • (b) prescription drugs;

    • (c) drugs that are listed in Schedule C or D to the Act; and

    • (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (drogue)

    foreign regulatory authority

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

    List of Drugs for Exceptional Importation and Sale

    List of Drugs for Exceptional Importation and Sale means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)

  • (2) In sections C.10.006 and C.10.009, batch certificate, fabricate, MRA country, package/label and recognized building have the same meanings as in subsection C.01A.001(1).

  •  (1) The Minister may add a drug to the List of Drugs for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that

    • (a) there is a shortage or risk of shortage of another drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01 or for which a drug identification number has been assigned under subsection C.01.014.2(1); and

    • (b) the drug to be added to that list can be substituted for the drug referred to in paragraph (a).

  • (2) In subsection (1), shortage has the same meaning as in section C.01.014.8.

  •  (1) A person who holds an establishment licence that authorizes the importation of a drug may import a designated drug if the following conditions are met:

    • (a) the licensee provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the third business day before the day on which the designated drug is imported, with a notification that contains the following information:

      • (i) the licensee’s name and contact information,

      • (ii) the name and contact information of each fabricator, packager/labeller and tester of the designated drug and the address of each building in which it is fabricated, packaged/labelled or tested,

      • (iii) in respect of the designated drug,

        • (A) its brand name,

        • (B) its medicinal ingredients,

        • (C) its dosage form,

        • (D) its strength,

        • (E) its route of administration,

        • (F) its identifying code or number, if any, assigned in the country in which it is authorized for sale, and

        • (G) a detailed description of its conditions of use,

      • (iv) the intended port of entry into Canada,

      • (v) the estimated date of arrival of the shipment of the designated drug, and

      • (vi) the total quantity of the designated drug that is intended to be imported on the date referred to in subparagraph (v);

    • (b) the designated drug is authorized to be sold by a foreign regulatory authority within its jurisdiction;

    • (c) the designated drug is in the same category as the category for which the establishment licence was issued;

    • (d) the following information is set out in the List of Drugs for Exceptional Importation and Sale in respect of the designated drug:

      • (i) the licensee’s name,

      • (ii) the information referred to in clauses (a)(iii)(A) to (F),

      • (iii) the name of the foreign regulatory authority referred to in paragraph (b), and

      • (iv) the date after which it may no longer be imported;

    • (e) the lot number of the designated drug is set out in the list referred to in paragraph (d), if applicable;

    • (f) the total quantity of the designated drug that the licensee imports does not exceed the maximum limit specified in the list referred to in paragraph (d) in respect of the drug, if applicable;

    • (g) the designated drug is imported on or before the date referred to in subparagraph (d)(iv); and

    • (h) the licensee has prepared a plan that specifies the measures to be taken in order for the licensee to comply with section C.10.011.

  • (2) In subsection (1), business day means a day other than

    • (a) a Saturday; or

    • (b) a Sunday or other holiday.

 
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