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

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.