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

Regulations are current to 2019-02-28 and last amended on 2019-01-15. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

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

 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 [Repealed, SOR/2017-259, s. 11]

 [Repealed, SOR/2017-259, s. 11]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    • (b) [Repealed, SOR/98-423, s. 7]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.

Prohibition

 No manufacturer shall sell a drug unless the manufacturer complies with the conditions set out in sections C.01.017 to C.01.019.

  • SOR/95-521, s. 2;
  • SOR/2011-31, s. 1.

Serious Adverse Drug Reaction Reporting

 The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first:

  • (a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and

  • (b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug.

  • SOR/95-521, s. 2;
  • SOR/2011-31, s. 1.

Annual Summary Report and Case Reports

  •  (1) The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months.

  • (2) The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug.

  • (3) In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection (2), whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report.

  • (4) If, in preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done.

  • (5) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following:

    • (a) the annual summary reports;

    • (b) the case reports relating to the adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer.

  • (6) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the annual summary reports or case reports, or both, that is reasonable in the circumstances, and the manufacturer shall submit the reports within that period.

  • SOR/2011-31, s. 1.

 Section C.01.018 does not apply in respect of a veterinary health product.

  • SOR/2017-76, s. 4.

Issue-Related Summary Report

  •  (1) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister an issue-related summary report.

  • (2) The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report.

  • (3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may only specify a period that is less than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health.

  • (4) The manufacturer shall submit the report within the specified period.

  • SOR/2011-31, s. 1;
  • SOR/2017-18, s. 14.

 Section C.01.019 does not apply in respect of a veterinary health product.

  • SOR/2017-76, s. 5.

Maintenance of Records

  •  (1) The manufacturer shall maintain records of the reports and case reports referred to in sections C.01.017 to C.01.019.

  • (2) The manufacturer shall retain the records for 25 years after the day on which they were created.

  • SOR/2011-31, s. 1.

Limits of Drug Dosage

 Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and the outer labels other than the inner label of a single dose container carry a statement of

  • (a) the quantitative content of the drug,

  • (b) the recommended single and daily adult dose designated as such, except for

    • (i) preparations solely for external use, or

    • (ii) preparations solely for children’s use; and

  • (c) adequate directions for use when the drug is recommended for children which shall be either

    • (i) the statement “CHILDREN: As directed by the physician”, or

    • (ii) a suitable reduced maximum single and daily dose which shall not exceed the following:

      Age in yearsProportion of adult dose
      blank lineblank line
      10 - 14one-half
      5 - 9one-fourth
      2 - 4one-sixth
      under 2 yearsas directed by physician

      TABLE

      Table of Limits of Drug Dosage for Adults

      ItemExternal UseInternal Use
      Maximum LimitMaximum Dosage Unless otherwise stated, doses are in milligrams
      Per centSingleDaily
      Acetaminophen blank line6504.0 g
      Acetanilide and derivatives (except N-Acetyl-ρ-amino phenol) blank line65195
      Acetylsalicylic Acid blank line6504.0 g
      Aconitine, its preparations and derivatives blank line0.20.10.1
      Adonis vernalis blank line65195
      Amylocaine, its salts and derivatives when sold or recommended for opthalmic use blank line0.00.00.0
      Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use blank line1.00.00.0
      Antimony, compounds of blank line3.313
      Atropine, Methylatropine, and their salts blank line1.00.130.44
      Belladonna and its preparations, on the basis of belladonna alkaloids blank line0.3750.130.44
      Benzene (Benzol) blank line
      Benzocaine blank line8.0195585
      Beta-Naphthol blank line195585
      Butacaine, its salts and derivatives when sold or recommended for ophthalmic use blank line0.00.00.0
      Butacaine Sulphate, except when sold or recommended for opthalmic use blank line1.00.00.0
      Cadexomer Iodine blank line0.00.00.0
      Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters blank line0.030.00.0
      Cantharides, blisters only blank line0.20.00.0
      Cedar Oil blank line25.00.00.0
      Chlorbutol (not more often than every 4 hours) blank line325975
      Choline Salicylate blank line8705.22 g
      Cinchocaine Hydrochloride, except suppositories blank line1.00.00.0
      Cinchocaine Hydrochloride, suppositories only blank line1111
      Colchicine and its salts blank line0.551.65
      Colchicum and its preparations, on the basis of colchicine blank line0.270.81
      Croton Oil blank line10.00.00.0
      Cyproheptadine and its salts—when sold or recommended for the promotion of weight gain0.00.0
      Ephedrine and its salts blank line1132.5
      Ephedrine and its salts, sprays blank line1.0
      Epinephrine and its salts, sprays blank line1.0
      Gelseminine (Gelsemine) and its salts (not to be repeated within 4 hours) blank line0.551.65
      Gelsemium and its preparations, on the basis of the crude drug blank line16.248.6
      Hydrocyanic (Prussic) Acid as 2 per cent solution blank line0.062 ml0.31 ml
      Hydroquinone blank line2.0
      Hyoscine (Scopolamine) and its salts blank line0.50.3250.975
      Hyoscine aminoxide hydrobromide blank line0.50.3250.975
      Hyoscyamine and its salts blank line0.3250.975
      Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids blank line0.0730.22
      Lobelia and its preparations, on the basis of the crude drug blank line130390
      Lobeline and its salts blank line2.06.0
      Magnesium Salicylate blank line6504.0 g
      Methyl Salicylate blank line30
      Methylene Blue blank line130390
      Phenacetin blank line6501.95 g
      Phenazone and compounds thereof blank line325975
      Phenol blank line2.032.5260
      Phenylpropanolamine when sold or recommended as an appetite depressent blank line0.00.0
      Phosphorus blank line0.00.0
      Podophyllin blank line0.00.00.0
      Potassium Chlorate blank line325975
      Potassium Chlorate, gargle blank line2.5
      Procaine and its salts blank line
      Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use blank line0.00.00.0
      Salicylamide blank line9752.925 g
      Santonin blank line65130
      Selenium and its compounds blank line2.50.00.0
      Sodium Chlorate blank line325975
      Sodium Fluoride blank line0.10.1
      Sodium Salicylate blank line6504.0 g
      Squill and its preparations, on the basis of crude drug blank line32.597.5
      Stramonium and its preparations, on the basis of stramonium alkaloids blank line0.160.65
      Strychnine and its salts blank line0.00.0
      Tannic Acid blank line1501 000
      Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use blank line0.00.00.0
      Thiocyanates blank line0.00.00.0
      Urethane blank line0.00.00.0

      Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced.

      Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.

  • SOR/78-422, s. 1;
  • SOR/80-544, s. 3;
  • SOR/84-145, s. 1;
  • SOR/85-715, s. 3;
  • SOR/85-966, s. 2;
  • SOR/88-94, s. 1;
  • SOR/89-229, s. 2;
  • SOR/89-548, s. 1.
 
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