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

• C.08.015 (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Minister has determined that

  • (a) the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study,

  • (b) the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and

  • (c) the proposed experimental study can be conducted without undue foreseeable risk to humans or animals,

  the Minister shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator.

• (2) If, on receipt of the information and material submitted under section C.08.014, the Minister determines that the requirements of paragraphs (1)(a), (b) and (c) have not been met, the Minister shall refuse to issue an experimental studies certificate.

Labelling

• C.08.016 (1) The label of a new drug that is sold pursuant to section C.08.013 shall show

  • (a) the brand name of the new drug or the identifying name or code proposed for the new drug;

  • (b) a warning statement to the effect that the drug is for use only in an experimental study in animals;

  • (c) the lot number of the drug;

  • (d) the name and address of the manufacturer of the drug; and

  • (e) the name of the person to whom the drug has been supplied.

• (2) Sections C.01.004, C.01.005 and C.01.014 do not apply to a drug that is sold pursuant to section C.08.013 and labelled in accordance with subsection (1).

Conditions of Experimental Study

C.08.017 An experimental studies investigator shall

• (a) use the new drug only in accordance with the outline of the experimental study;

• (b) report immediately to the Minister all serious adverse drug reactions associated with the use of the new drug;

• (c) report promptly to the Minister, on request, the results of the experimental study;

• (d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;

• (e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Minister;

• (f) report promptly to the Minister any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and

• (g) account to the Minister, on request, for all quantities of the new drug received by him.

Suspension or Cancellation of Experimental Studies Certificate

• C.08.018 (1) If the Minister determines that it is necessary in order to safeguard animal health or public health or to promote public safety, he or she may suspend for a definite or indefinite period or cancel an experimental studies certificate.

• (2) Without limiting the generality of subsection (1), the Minister may suspend or cancel an experimental studies certificate if

  • (a) the information and material submitted pursuant to section C.08.014 contains an untrue statement or contains any omission concerning the properties of the drug that were known or ought reasonably to have been known to the manufacturer or the experimental studies investigator;

  • (b) the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete;

  • (c) the qualifications of the experimental studies investigator prove to be inadequate;

  • (d) there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or

  • (e) an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002.

DIVISION 9

Non-prescription Drugs

C.09.001 This Division does not apply to

• (a) a drug that is required by these Regulations or the Narcotic Control Regulations to be sold only on prescription; or

• (b) a drug for use exclusively in animals.

Analgesics

General

C.09.010 No manufacturer or importer shall, after June 30, 1986, sell a drug for analgesia that contains a combination of

• (a) a salt or derivative of salicylic acid with another salt or derivative of salicylic acid or with salicylamide; or

• (b) acetaminophen with a salt or derivative of salicylic acid or with salicylamide.

C.09.011 Each label of a drug that is intended for internal use and contains acetaminophen, salicylic acid or a salt or derivative thereof shall, after June 30, 1986, carry a caution

• (a) to consult a physician if the underlying condition requires continued use for more than five days; and

• (b) that it is hazardous to exceed the maximum recommended dose unless advised by a physician.

C.09.012 Each label of a drug that is intended for internal use and contains salicylic acid or a salt or derivative thereof shall after June 30, 1986, carry a warning statement to consult a physician before taking the drug during the last three months of pregnancy or when nursing.

Acetaminophen

• C.09.020 (1) The adult standard dosage unit of acetaminophen shall be 325 mg.

• (2) The children’s standard dosage units of acetaminophen shall be 80 mg or 160 mg.

• C.09.021 (1) In this Division, acetaminophen product means a drug that contains

  • (a) acetaminophen as a single medicinal ingredient; or

  • (b) acetaminophen in combination with caffeine.

• (2) No manufacturer or importer shall sell an acetaminophen product unless it meets the requirements of this Division.

• (3) [Repealed, SOR/90-587, s. 5]

• C.09.022 (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.

Salicylates

• C.09.030 (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.

• C.09.031 (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.

• C.09.032 (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.

• C.09.033 (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.

C.09.034 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.

C.09.035 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.

DIVISION 10Access to Drugs in Exceptional Circumstances

• C.10.001 (1) The following definitions apply in this section and in section C.10.002.

  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 Department of Indigenous Services. (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);

  • (c.1) section C.02.012.1 as it applies to the storage of the drug by the licensee;

  • (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.