Food and Drug Regulations
C.01A.002 (1) This Division does not apply to
(a) wholesaling a drug premix;
(b) subject to subsection (3), importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons:
(i) a pharmacist,
(ii) a practitioner, and
(iii) a person who compounds a drug under the supervision of a practitioner;
(b.1) any activity with respect to a positron-emitting radiopharmaceutical that is used only for the purposes of a basic clinical research study described in section C.03.304;
(c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.005;
(d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributer referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A.1 to the Act, namely,
(i) homeopathic drugs,
(ii) drugs that meet the requirements of a class monograph entitled “Vitamin Supplements”, “Mineral Supplements”, “Dietary Vitamin Supplements” or “Dietary Mineral Supplements”, as the case may be, and
(iii) drugs that
(A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and
(B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and
(e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.
(1.1) This Division and Division 2 do not apply to a veterinary health product or an active pharmaceutical ingredient that is used in the fabrication of a veterinary health product.
(2) This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.
(3) This Division applies to the importing, by a pharmacist, a veterinary practitioner or a person who compounds a drug under the supervision of a veterinary practitioner, of an active pharmaceutical ingredient for veterinary use that is for the purpose of compounding, pursuant to a prescription, a drug in dosage form that is not commercially available in Canada, if that ingredient is set out in List A.
- SOR/97-12, s. 5
- SOR/98-7, s. 2
- SOR/2001/-203, s. 1
- SOR/2004-282, s. 2
- SOR/2012-129, s. 1
- SOR/2017-76, s. 8
- SOR/2021-46, s. 10
- Date modified: