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

Regulations are current to 2022-11-16 and last amended on 2022-09-27. Previous Versions

PART CDrugs (continued)

DIVISION 8 (continued)

Sale of New Drug for Emergency Treatment (continued)

[
  • SOR/2020-212, s. 1(F)
]
  •  (1) Despite subsection C.01A.004(1), the holder of an establishment licence may import a new drug in accordance with a letter issued under subsection C.08.011.1(1).

  • (2) Section C.01A.006 and Divisions 2 to 4, except for the following provisions, do not apply to the importation of a new drug referred to in the letter of authorization:

    • (a) sections C.02.003.1 and C.02.004, as they apply to the storage of the new drug by the holder of an establishment licence;

    • (b) section C.02.006, as it applies to the storage of the new drug by the holder of an establishment licence;

    • (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 new drug by the holder of an establishment licence;

    • (f) subsection C.02.021(1), as it applies to the storage of the new drug by the holder of an establishment licence;

    • (g) subsection C.02.022(1);

    • (h) section C.02.023;

    • (i) subsection C.02.024(1);

    • (j) section C.03.013; and

    • (k) section C.04.001.1, as it applies to the storage of the new drug by the holder of an establishment licence.

  •  (1) Despite section C.08.002, the holder of an establishment licence who imports a new drug under section C.08.011.2 may distribute a new drug in accordance with a letter of authorization issued under subsection C.08.010(1).

  • (2) The holder of an establishment licence who distributes to a practitioner, in accordance with subsection (1), a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A must submit to the Minister, in the form established by the Minister, an annual report identifying the total quantity of the new drug that was distributed, including an estimate of the quantity distributed in respect of each animal species for which the drug is intended.

  • (3) The distribution of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section.

Sale of Medicated Feeds

  •  (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if

    • (a) as regards the drug or drugs used as the medicating ingredient of the medicated feed,

      • (i) the Minister has assigned a drug identification number pursuant to section C.01.014.2, or

      • (ii) the sale is permitted by section C.08.005, C.08.011 or C.08.013;

    • (b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription;

    • (c) the medicated feed is for therapeutic purposes only; and

    • (d) the written prescription contains the following information:

      • (i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed,

      • (ii) the species, production type and age or weight of the animals to be treated with the medicated feed,

      • (iii) the type and amount of medicated feed to be mixed,

      • (iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients,

      • (v) any special mixing instructions, and

      • (vi) labelling instructions including

        • (A) feeding instructions,

        • (B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and

        • (C) where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.

  • (2) For the purpose of this section, medicated feed has the same meaning as in the Feeds Regulations.

  • SOR/80-741, s. 1
  • SOR/92-130, s. 1
  • SOR/93-202, s. 27
  • SOR/2018-69, s. 27

Experimental Studies

Conditions of Sale
  •  (1) Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Minister for the purpose of conducting an experimental study in animals if

    • (a) the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and

    • (b) the drug is labelled in accordance with subsection C.08.016(1).

  • (2) For the purposes of this section and sections C.08.014 to C.08.018,

    experimental studies certificate

    experimental studies certificate means a certificate issued pursuant to subsection C.08.015(1); (certificat d’études expérimentales)

    experimental studies investigator

    experimental studies investigator means a person named as the investigator in an experimental studies certificate; (expert en études expérimentales)

    experimental study

    experimental study means a limited test of a new drug in animals carried out by an experimental studies investigator. (étude expérimentale)

  • SOR/81-333, s. 1
  • SOR/2018-69, s. 27
Experimental Studies Certificate
  •  (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Minister, in writing, the following information and material:

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

    • (b) the objectives and an outline of the proposed experimental study of the new drug;

    • (c) the species, number and production type of animals in respect of which the new drug is to be administered;

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

    • (e) the address of the premises in which the experimental study is to be conducted;

    • (f) a description of the facilities to be used to conduct the experimental study;

    • (g) the name, address and qualifications of the proposed experimental studies investigator;

    • (h) the chemical structure, if known, and the relevant compositional characteristics of the new drug;

    • (i) the proposed quantity of the new drug to be used for the experimental study;

    • (j) the results of any toxicological or pharmacological studies that may have been conducted with the new drug;

    • (k) the written agreement referred to in subsection (2); and

    • (l) such other information and material as the Minister may require.

  • (2) Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator.

  • (3) The Minister may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other information that the Minister requests and where such samples or information are not submitted, the Minister may refuse to issue an experimental studies certificate.

  • SOR/81-333, s. 1
  • SOR/93-202, s. 28
  • SOR/2018-69, s. 27
  •  (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 is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he or she shall refuse to issue an experimental studies certificate.

Labelling
  •  (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).

  • SOR/81-333, s. 1
  • SOR/88-378, s. 2
  • SOR/93-202, s. 29
Conditions of Experimental Study

 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.

  • SOR/81-333, s. 1
  • SOR/2001-203, s. 10
  • SOR/2018-69, s. 27
Suspension or Cancellation of Experimental Studies Certificate
  •  (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.

  • SOR/81-333, s. 1
  • SOR/2018-69, ss. 26, 27

DIVISION 9

Non-prescription Drugs

 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.

  • SOR/84-145, s. 4

Analgesics

General

 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.

  • SOR/84-145, s. 4

 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.

  • SOR/84-145, s. 4
  • SOR/86-589, s. 1

 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.

  • SOR/84-145, s. 4

Acetaminophen

  •  (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.

  • SOR/84-145, s. 4
  • SOR/90-587, s. 4
  •  (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]

  • SOR/84-145, s. 4
  • SOR/90-587, s. 5
 
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