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

C.01.051. Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Director the following information:

• (a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number;

• (b) in the case of an imported drug, the names of the manufacturer and importer;

• (c) the quantity of the drug manufactured or imported;

• (d) the quantity of the drug distributed;

• (e) the quantity of the drug remaining on the premises of the manufacturer or importer;

• (f) the reasons for initiating the recall; and

• (g) a description of any other action taken by the manufacturer or importer with respect to the recall.

C.01.052. [Repealed, SOR/82-524, s. 2]

C.01.055. and C.01.056. [Repealed, SOR/82-524, s. 2]

• C.01.061. (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 subsection G.01.001(1) 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.

  Item	Column I	Column II
  	Labelled Number of Dosage Units Per Package	Permitted Variation from the Labelled Number
  1.	50 or less	0
  2.	More than 50, but less than 101	1
  3.	101 or more	the greater of one unit or 0.75% of the labelled number, rounded up to the next whole number