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

Regulations are current to 2018-07-05 and last amended on 2018-06-13. Previous Versions

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
      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 6504.0 g
      Acetanilide and derivatives (except N-Acetyl-ρ-amino phenol) 65195
      Acetylsalicylic Acid 6504.0 g
      Aconitine, its preparations and derivatives 0.20.10.1
      Adonis vernalis 65195
      Amylocaine, its salts and derivatives when sold or recommended for opthalmic use 0.00.00.0
      Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use 1.00.00.0
      Antimony, compounds of 3.313
      Atropine, Methylatropine, and their salts 1.00.130.44
      Belladonna and its preparations, on the basis of belladonna alkaloids 0.3750.130.44
      Benzene (Benzol)
      Benzocaine 8.0195585
      Beta-Naphthol 195585
      Butacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0
      Butacaine Sulphate, except when sold or recommended for opthalmic use 1.00.00.0
      Cadexomer Iodine 0.00.00.0
      Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters 0.030.00.0
      Cantharides, blisters only 0.20.00.0
      Cedar Oil 25.00.00.0
      Chlorbutol (not more often than every 4 hours) 325975
      Choline Salicylate 8705.22 g
      Cinchocaine Hydrochloride, except suppositories 1.00.00.0
      Cinchocaine Hydrochloride, suppositories only 1111
      Colchicine and its salts 0.551.65
      Colchicum and its preparations, on the basis of colchicine 0.270.81
      Croton Oil 10.00.00.0
      Cyproheptadine and its salts—when sold or recommended for the promotion of weight gain0.00.0
      Ephedrine and its salts 1132.5
      Ephedrine and its salts, sprays 1.0
      Epinephrine and its salts, sprays 1.0
      Gelseminine (Gelsemine) and its salts (not to be repeated within 4 hours) 0.551.65
      Gelsemium and its preparations, on the basis of the crude drug 16.248.6
      Hydrocyanic (Prussic) Acid as 2 per cent solution 0.062 ml0.31 ml
      Hydroquinone 2.0
      Hyoscine (Scopolamine) and its salts 0.50.3250.975
      Hyoscine aminoxide hydrobromide 0.50.3250.975
      Hyoscyamine and its salts 0.3250.975
      Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids 0.0730.22
      Lobelia and its preparations, on the basis of the crude drug 130390
      Lobeline and its salts 2.06.0
      Magnesium Salicylate 6504.0 g
      Methyl Salicylate 30
      Methylene Blue 130390
      Phenacetin 6501.95 g
      Phenazone and compounds thereof 325975
      Phenol 2.032.5260
      Phenylpropanolamine when sold or recommended as an appetite depressent 0.00.0
      Phosphorus 0.00.0
      Podophyllin 0.00.00.0
      Potassium Chlorate 325975
      Potassium Chlorate, gargle 2.5
      Procaine and its salts
      Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0
      Salicylamide 9752.925 g
      Santonin 65130
      Selenium and its compounds 2.50.00.0
      Sodium Chlorate 325975
      Sodium Fluoride 0.10.1
      Sodium Salicylate 6504.0 g
      Squill and its preparations, on the basis of crude drug 32.597.5
      Stramonium and its preparations, on the basis of stramonium alkaloids 0.160.65
      Strychnine and its salts 0.00.0
      Tannic Acid 1501 000
      Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0
      Thiocyanates 0.00.00.0
      Urethane 0.00.00.0

      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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