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

Stability

• C.02.027 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.

• (2) Every fabricator and importer of an active ingredient shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.

• C.02.028 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

• (2) Every fabricator and importer of an active ingredient shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

Sterile Products

C.02.029 In addition to the other requirements of this Division, a drug that is intended to be sterile shall be fabricated and packaged/labelled

• (a) in separate and enclosed areas;

• (b) under the supervision of personnel trained in microbiology; and

• (c) by a method scientifically proven to ensure sterility.

Medical Gases

C.02.030 The provisions of sections C.02.025, C.02.027 and C.02.028 do not apply to medical gases.

DIVISION 3

Schedule C Drugs

C.03.001 In this Division,

drug

drug means a drug that is listed in Schedule C to the Act that is in dosage form or a drug that is an active ingredient of biological origin that can be used in the preparation of a drug listed in that Schedule; (drogue)

licence

licence or Canadian licence[Repealed, SOR/97-12, s. 22]

manufacturer

manufacturer[Repealed, SOR/97-12, s. 22]

master lot

master lot means a quantity of a drug from which a lot is prepared for sale by subsequent dilution or mixture; (maître-lot)

radionuclide generator

radionuclide generator means a radioactive parent and daughter

• (a) contained in an ion-exchange column, or

• (b) dissolved in a suitable solvent in a liquid-liquid extraction system

where the radioactive daughter is separated from its parent by

• (c) elution from the ion exchange column, or

• (d) a solvent extraction procedure. (générateur de radionucléide)

C.03.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.

C.03.002 to C.03.005 [Repealed, SOR/97-12, s. 24]

C.03.006 [Repealed, SOR/97-12, s. 67]

C.03.007 to C.03.011 [Repealed, SOR/97-12, s. 26]

C.03.012 On written request from the Minister, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot or master lot of the drug before it is sold, and no person shall sell a lot of which the protocol or sample fails to meet the requirements of these Regulations.

C.03.013 No person shall fabricate or import a drug that is derived from animal tissue unless the tissue is obtained from a healthy animal free from infectious disease.

• C.03.014 (1) Section C.01.004 does not apply to a drug.

• (2) and (3) [Repealed, SOR/97-12, s. 28]

• C.03.015 (1) Every package of a drug that is a prescription drug shall carry the symbol “Pr” on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label.

• (2) Subsection (1) does not apply to

  • (a) a drug sold to a drug fabricator;

  • (b) a drug sold under a prescription;

  • (c) a radiopharmaceutical as defined in section C.03.201; or

  • (d) a component or kit as defined in section C.03.205.

C.03.030 to C.03.045 [Repealed, SOR/81-335, s. 2]

Radiopharmaceuticals

C.03.201 In these Regulations, radiopharmaceutical means a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons.

• C.03.202 (1) Every package containing a radiopharmaceutical, other than a radionuclide generator, shall carry,

  • (a) on both the inner and the outer labels,

    • (i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name,

    • (ii) the name of the distributor referred to in paragraph C.01A.003(b),

    • (iii) the lot number, and

    • (iv) the drug identification number assigned for the radiopharmaceutical, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”; and

  • (b) on the outer label

    • (i) the address of the distributor referred to in paragraph C.01A.003(b),

    • (ii) the standard that the drug professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act,

    • (iii) a statement of the pharmaceutical form or the route of administration of the drug,

    • (iv) a statement of the recommended use and the recommended radioactivity to be administered for that use, or a reference to an accompanying package insert that shows such information,

    • (v) [Repealed, SOR/2017-259, s. 16]

    • (vi) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”,

    • (vii) the names and a statement of the amounts of any preservatives or stabilizing agents contained in the drug,

    • (viii) the names and a statement of the amounts of all other non-radioactive contents of the drug,

    • (ix) a statement of the total radioactivity content of the drug including overfill,

    • (x) a statement of the total volume of the drug including overfill, except where its contents are entirely in gaseous, capsule or lyophilized form,

    • (xi) a statement of the concentration of radioactive material in the drug expressed as

      • (A) units of radioactivity per capsule or

      • (B) units of radioactivity per unit volume,

      except where the contents of the drug are entirely in gaseous or lyophilized form,

    • (xii) a statement of the specific activity of the drug expressed as units of radioactivity per unit weight of carrier present or the statement “carrier-free” or “sans entraîneur”, whichever is applicable,

    • (xiii) a statement of the reference time in respect of the radioactivity values mentioned in subparagraphs (ix), (xi) and (xii), the name of the month being written or designated by letter abbreviation,

    • (xiv) a statement of the recommended useful life or the date after which the drug is not recommended for use, the name of the month being written or designated by letter abbreviation, and

    • (xv) a statement of the special storage requirements with reference to temperature and light.

• (2) Subparagraph (1)(a)(iv) does not apply to a radiopharmaceutical that is

  • (a) compounded by a pharmacist under a prescription or by a practitioner; or

  • (b) sold under a prescription, if the radiopharmaceutical’s label indicates

    • (i) its proper name, common name or brand name,

    • (ii) its potency, and

    • (iii) the name of its manufacturer.

• (3) Subparagraph (1)(b)(viii) of this section does not apply where the information referred to in that subparagraph is shown on a package insert that accompanies the drug.

• (4) Section C.01.005 does not apply to a radiopharmaceutical.

• C.03.203 (1) Every radionuclide generator shall carry on the inner label

  • (a) the proper name of the radionuclide generator, which proper name, where there is a brand name, shall immediately precede or follow the brand name;

  • (b) the name and address of the distributor referred to in paragraph C.01A.003(b);

  • (c) the lot number;

  • (d) the standard that the radionuclide generator professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act;

  • (e) the drug identification number assigned for the radionuclide generator, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”;

  • (f) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”;

  • (g) a statement of the total parent radioactivity contained in the radionuclide generator;

  • (h) a statement of the hour and date at which the radioactivity value mentioned in paragraph (g) is valid, the name of the month being written or designated by letter abbreviation;

  • (i) a statement of the recommended useful life or the date after which the radionuclide generator is not recommended for use, the name of the month being written or designated by letter abbreviation;

  • (j) a statement of the recommended useful life of the drug after removal from the radionuclide generator;

  • (k) a statement of special storage requirements with reference to temperature or shielding;

  • (l) complete directions for use or a reference to an accompanying package insert that sets out such directions; and

  • (m) a statement cautioning against the dismantling of the radionuclide generator.

• (2) Paragraphs (1)(i) and (j) of this section do not apply where the information referred to in those subparagraphs is shown on a package insert that accompanies the radionuclide generator.

• (3) Section C.01.005 does not apply to a radionuclide generator.

• C.03.204 (1) No person shall sell a drug that contains technetium-99m at any time during its useful life if it also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph.

• (2) No person shall sell a radionuclide generator from which can be removed a drug that contains technetium-99m, at any time during the useful life of the drug, if the drug also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph.

Drugs, Other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals

C.03.205 The following definitions apply in this section and in sections C.03.206 to C.03.209.

component

component means

• (a) a unit of a drug, other than a radionuclide, separately packaged in a kit; or

• (b) an empty vial or other accessory item in a kit. (constituant)

kit

kit means a package that is intended to be used in the preparation of radiopharmaceuticals and that

• (a) contains one or more separately packaged units of a drug, other than a radionuclide; and

• (b) may contain empty vials or other accessory items. (trousse)

C.03.206 Sections C.01.005 and C.04.019 do not apply to a component or kit.

• C.03.207 (1) Every component shall be labelled to show

  • (a) adequate identification of the component and an adequate description of its function;

  • (b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information;

  • (c) the name of the distributor referred to in paragraph C.01A.003(b);

  • (d) the lot number;

  • (e) a statement of any special storage requirements with respect to temperature and light;

  • (f) the date after which the component is not recommended for use, the name of the month being written in full or designated by letter abbreviation; and

  • (g) adequate directions for use or a reference to the accompanying package insert that shows such directions.

• (2) The component of a kit that is intended to contain the prepared radiopharmaceutical shall be labelled to display the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.