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

Regulations are current to 2020-11-17 and last amended on 2020-09-28. Previous Versions

PART CDrugs (continued)

DIVISION 3 (continued)

Schedule C Drugs (continued)

 [Repealed, SOR/97-12, s. 24]

 [Repealed, SOR/97-12, s. 67]

 [Repealed, SOR/97-12, s. 26]

 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.

  • SOR/97-12, s. 27
  • SOR/2018-69, s. 27

 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.

  • SOR/97-12, s. 27
  • SOR/79-236, s. 1
  • SOR/93-202, s. 15
  • SOR/97-12, s. 28
  •  (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.

  • SOR/80-543, s. 9
  • SOR/97-12, s. 61
  • SOR/2001-181, s. 4
  • SOR/2013-122, s. 16

 [Repealed, SOR/81-335, s. 2]

Radiopharmaceuticals

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

  • SOR/97-12, s. 29
  •  (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.

  • SOR/79-236, s. 2
  • SOR/93-202, s. 16
  • SOR/97-12, ss. 54, 58, 62
  • SOR/2001-203, s. 2
  • SOR/2012-129, s. 2
  • SOR/2017-259, s. 16
  • SOR/2018-69, s. 35(F)
  •  (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.

  • SOR/79-236, s. 3
  • SOR/93-202, s. 17
  • SOR/97-12, ss. 54, 58, 62
  • SOR/2012-129, s. 3
  • SOR/2017-259, s. 17
  • SOR/2018-69, ss. 21(F), 22(F)
 
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