Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Food and Drug Regulations

Version of section C.01.061 from 2019-12-09 to 2020-03-05:

  •  (1) Where the net amount of a drug in a package is not expressed on the label in terms of number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain an amount of the drug such that, when determined by that official method, the average of the net amounts of the drug in the 10 packages is not less than the net amount of the drug shown on the label.

  • (2) Where the net amount of a drug in a package is expressed on the label in terms of the number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain a number of units such that, when determined by that official method,

    • (a) the average number of dosage units in the 10 packages is not less than the number of dosage units shown on the label;

    • (b) no package contains less than the number of dosage units shown on the label except as provided in the table; and

    • (c) where the drug is a controlled drug as defined in section G.01.001 or a narcotic as defined in the Narcotic Control Regulations, no package contains more than the number of dosage units shown on the label except as provided in the table to this section.

    TABLE

    ItemColumn IColumn II
    Labelled Number of Dosage Units Per PackagePermitted Variation from the Labelled Number
    150 or less0
    2More than 50, but less than 1011
    3101 or morethe greater of one unit or 0.75% of the labelled number, rounded up to the next whole number
  • SOR/82-429, s. 4
  • SOR/89-455, s. 4
  • SOR/97-228, s. 3
  • SOR/2019-171, s. 24
Date modified: