The Alberta College of Pharmacy (ACP) has observed an increase in the distribution of compounded and repackaged drugs to and from pharmacies located in other Canadian provinces and territories (jurisdictions).
Considering this increased activity, ACP has reviewed the regulatory framework governing the practice of pharmacists and pharmacy technicians, and the operation of licenced pharmacies in Alberta. When enacted, the Pharmacy and Drug Act (PDA) introduced compounding and repackaging (C&R) pharmacy licences, enabling the holder of a C&R licence to provide compounded or repackaged drugs to a community pharmacy, satellite pharmacy, or institution pharmacy as defined in the PDA. The legislation was not structured to support C&R pharmacy services for pharmacies located in other jurisdictions, as by definition, they can only provide services to a licensed pharmacy or institution pharmacy as established in the PDA.
ACP engaged with other provincial pharmacy regulatory authorities to learn about their policies related to compounding and repackaging.
The result of this review is the following changes in policy for community, satellite, and C&R pharmacies licensed in Alberta, effective April 1, 2025:
- An Alberta C&R pharmacy MUST ONLY compound or repackage drugs for an entity that is a licensed or institution pharmacy located IN Alberta.
- An Alberta community or satellite pharmacy MUST ONLY receive compounded or repackaged drugs from a C&R pharmacy licensed in Alberta.
Collectively, this means, that compounded and repackaged drugs cannot be provided from other jurisdictions to licensed pharmacies in Alberta, nor can compounded and repackaged drugs be provided by licensed pharmacies in Alberta to those in other jurisdictions.
What do licensees of community, satellite, and C&R pharmacies need to do?
The April 1, 2025, implementation date provides licensees time to implement the above policy changes, meet the requirements of the new Standards for the Operation of Licensed Pharmacies, and be ready to apply for renewal of their pharmacy licence in 2025. Licensees and proprietor’s representatives were notified about these changes by email in August 2024.
Community pharmacies that currently have arrangements to receive C&R pharmacy services from an entity located outside of Alberta must arrange for these services to cease prior to April 1, 2025. If C&R pharmacy services are required, they must be pursued with a C&R pharmacy licensed in Alberta. You can identify pharmacies located in Alberta that hold a C&R licence by using the C&R pharmacy directory on the ACP website.
Compounding and repackaging pharmacies located in Alberta that are providing C&R pharmacy services to pharmacies located outside of Alberta must arrange for these relationships to cease prior to April 1, 2025. C&R pharmacies are encouraged to establish contracts with community, satellite, and/or institution pharmacies located in Alberta.
C&R pharmacies must hold a federally issued Drug Establishment Licence to provide C&R pharmacy services to any entity that is not a licenced or institutional pharmacy.
ACP is reviewing and amending the current model compounding and repackaging agreement to reflect these interpretations. The amended version will be communicated to all pharmacies in early 2025, as new agreements will need to be entered into by C&R pharmacies with all community and institution pharmacies they provide services to.
