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

Regulations are current to 2017-11-06 and last amended on 2017-06-20. Previous Versions

 The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material.

  • SOR/82-524, s. 3.

Stability

  •  (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.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 58;
  • SOR/2013-74, s. 14.
  •  (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.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 58;
  • SOR/2013-74, s. 14.

Sterile Products

 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.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 21.

Medical Gases

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

  • SOR/85-754, s. 3.

DIVISION 3

Schedule C Drugs

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licence or Canadian licence[Repealed, SOR/97-12, s. 22]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manufacturer[Repealed, SOR/97-12, s. 22]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

  • SOR/97-12, s. 22;
  • SOR/2013-74, s. 15.

 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.

  • SOR/97-12, s. 23.

 [Repealed, SOR/97-12, s. 24]

 [Repealed, SOR/97-12, s. 67]

 [Repealed, SOR/97-12, s. 26]

 On written request from the Director, 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.

 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), and

      • (iii) the lot number; 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) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,

      • (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) [Repealed, SOR/2001-203, s. 2]

  • (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.
 
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