Recently, Health Canada issued a recall notice for compounded drugs containing semaglutide after a voluntary recall by an Alberta-based pharmacy, which compounded the drugs. The recalled product had been produced with an unauthorized active pharmaceutical ingredient (API) which had been imported from outside of Canada.
If a pharmacy team is interested in importing APIs for compounding, the API must be “not commercially available” in Canada, as outlined in C.01A.002(b) of the Food and Drug Regulations in order for the pharmacy to import said API without a Drug Establishment Licence. Health Canada has interpreted “not commercially available” to include drugs for which sales have been discontinued or suspended so the drug is not readily available to the practitioner at time of import and drugs in shortage, back order, dormant or approved but not marketed. The other criteria for pharmacy teams to follow for compounding drugs are outlined in POL-0051 Policy on Manufacturing and Compounding Drug Products in Canada.
The Drug Shortage Canada website comprises databases that can be searched by report or product for drugs and their shortage status. If you choose to import APIs for compounding, it is expected that you are aware of the status of the availability of the APIs in Canada at the time of purchase by contacting your Canadian supplier.
Additionally, review the Drug & Health Product Inspections database that comprises a list of all the licensed entities in Canada conducting activities with APIs prior to sourcing APIs. APIs must be sourced from reliable and recognized sources to ensure the maintenance of drug quality, safety, and integrity.
