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

Regulations are current to 2018-09-26 and last amended on 2018-06-13. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Shortages of Drugs and Interruption and Discontinuation of Sale of Drugs (continued)

 If a period of 12 months has elapsed since the day on which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug as defined in section C.01.014.8 last sold the drug, the manufacturer shall so notify the Minister in writing within 30 days after the day on which that period ends.

  • SOR/2017-259, s. 8.

 If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug resumes the sale of the drug after a period of 12 months has elapsed since the day on which they last sold the drug, the manufacturer shall so notify the Minister in writing within 30 days after the day on which they resume the sale of the drug.

  • SOR/2017-259, s. 8.

 The following definitions apply in this section and in sections C.01.014.9 and C.01.014.10.

drug

drug means any of the following drugs for human use for which a drug identification number has been assigned:

  • (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act;

  • (b) prescription drugs;

  • (c) drugs that are listed in Schedule C or D to the Act; and

  • (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (drogue)

shortage

shortage means, in respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug. (pénurie)

  • SOR/2016-139, s. 5;
  • SOR/2017-259, s. 8;
  • SOR/2018-69, ss. 17, 40.
  •  (1) If a shortage of a drug exists or is likely to occur, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall post the following information in English and French on a website that is operated by a party for that purpose with whom Her Majesty in right of Canada has entered into a contract to make that information available to the public:

    • (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them;

    • (b) the drug identification number assigned for the drug;

    • (c) the drug’s brand name and proper name or, if it does not have a proper name, its common name;

    • (d) the proper names of the drug’s medicinal ingredients or, if they do not have proper names, their common names;

    • (e) the drug’s therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for, the drug;

    • (f) the drug’s strength;

    • (g) the drug’s dosage form;

    • (h) the quantity of the drug contained in its package;

    • (i) the drug’s route of administration;

    • (j) the date when the shortage began or is anticipated to begin;

    • (k) the anticipated date when the manufacturer will be able to meet the demand for the drug, if they can anticipate that date; and

    • (l) the actual or anticipated reason for the shortage.

  • (2) The manufacturer shall post the information

    • (a) if they anticipate that a shortage will begin in more than six months, at least six months before the day on which they anticipate it to begin;

    • (b) if they anticipate that a shortage will begin in six months or less, within five days after the day on which they anticipate it; or

    • (c) if they did not anticipate the shortage, within five days after the day on which they become aware of it.

  • (3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.

  • (4) Within two days after the day on which the manufacturer is able to meet the demand for the drug, they shall post information on the website to that effect.

  • SOR/2016-139, s. 5;
  • SOR/2017-259, s. 9.
  •  (1) If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug decides to discontinue the sale of the drug, they shall post the following information in English and French on the website referred to in subsection C.01.014.9(1):

    • (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them;

    • (b) the drug identification number assigned for the drug;

    • (c) the drug’s brand name and proper name or, if it does not have a proper name, its common name;

    • (d) the proper names of the drug’s medicinal ingredients or, if they do not have proper names, their common names;

    • (e) the drug’s therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for, the drug;

    • (f) the drug’s strength;

    • (g) the drug’s dosage form;

    • (h) the quantity of the drug contained in its package;

    • (i) the drug’s route of administration;

    • (j) the date on which the manufacturer will discontinue the sale of the drug; and

    • (k) the reason for the discontinuation of sale.

  • (2) The manufacturer shall post the information

    • (a) if they decide to discontinue the sale of the drug in more than six months, at least six months before the day on which they will discontinue its sale; and

    • (b) if they decide to discontinue the sale of the drug in six months or less, within five days after the day on which that decision is made.

  • (3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.

  • SOR/2016-139, s. 5;
  • SOR/2017-259, s. 10.

 The Minister shall ensure that a hyperlink to the website referred to in subsection C.01.014.9(1) is on the Government of Canada website.

  • SOR/2016-139, s. 5;
  • SOR/2017-259, s. 11.

 [Repealed, SOR/2017-259, s. 11]

 [Repealed, SOR/2017-259, s. 11]

Tablet Disintegration Times

  •  (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989,

    • (a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes;

    • (b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and

    • (c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.

  • (2) Subsection (1) does not apply in respect of a drug in the form of a tablet where

    • (a) a notice of compliance in respect of the drug in the form of a tablet has been issued under section C.08.004 or C.08.004.01;

    • (b) [Repealed, SOR/98-423, s. 7]

    • (c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part;

    • (d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act;

    • (e) the drug has been demonstrated by an acceptable method to be available to the body; or

    • (f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.

  • SOR/89-429, s. 2;
  • SOR/89-455, s. 3;
  • SOR/94-36, s. 2;
  • SOR/98-423, s. 7;
  • SOR/2011-88, s. 4.
 
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