Food and Drug Regulations
(a) adequate identification of the component and an adequate description of its function;
(b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information;
(c) the name of the distributor referred to in paragraph C.01A.003(b);
(d) the lot number;
(e) a statement of any special storage requirements with respect to temperature and light;
(f) the date after which the component is not recommended for use, the name of the month being written in full or designated by letter abbreviation; and
(g) adequate directions for use or a reference to the accompanying package insert that shows such directions.
(2) The component of a kit that is intended to contain the prepared radiopharmaceutical shall be labelled to display the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.
- SOR/79-236, s. 4
- SOR/97-12, s. 58
- SOR/2017-259, s. 20
- SOR/2018-69, s. 23(F)
- Date modified: