Health Canada requirement for pharmacy veterinary compounding (Session 1)

An introduction to the new requirements under the Food and Drug Regulations affecting all health care practitioners who compound veterinary API. This is session for those who want to confirm that the activities they conduct require a DEL under the new rules, as well as to receive information on the sales reporting rules.

Do you import Active Pharmaceutical Ingredients that may be used in veterinary drugs? Are you a pharmacist or veterinarian who compounds antimicrobial drugs on List A for animals? If so, regulatory changes to the Food and Drug Regulations coming into force may affect you.

Starting May 17, 2018, health care professionals and importers may need to be inspected by Health Canada, need to comply with Good Manufacturing Practices (GMP), and need a Drug Establishment Licence (DEL).

Starting March 31, 2019, manufacturers, importers or compounders of antimicrobial drugs for veterinary use that contain an active pharmaceutical ingredient on List A will need to report annual sales data to Health Canada. This means data will need to be collected throughout 2018 for reporting by March 31, 2019.

You will find additional information on these new rules on the Canada.ca page. GMP and DEL guidance documents for human active pharmaceutical ingredients (APIs) can be applied to veterinary APIs and are being updated as needed.