During recent pharmacy inspections, practice consultants have observed that some pharmacies are completing unauthorized purchases or sales of compounded or repackaged drugs. Licensees must ensure licences and agreements are in place for compounding and repackaging services as required by the Pharmacy and Drug Act.
Purchasing compounded or repackaged drugs
Does your pharmacy purchase compounded or repackaged drugs from another pharmacy? If so, the licensee and pharmacy team must ensure the following:
- Your pharmacy holds a valid community pharmacy licence or is an institution pharmacy.
- The selling pharmacy holds a valid compounding and repackaging licence.
- You have an ACP-approved compounding and repackaging agreement in place that is current and signed before accepting compounded or repackaged products from the selling pharmacy.
- As the community pharmacy or institution pharmacy, your pharmacists are responsible for all patient assessments and other clinical interactions, and for ensuring the appropriateness of the drug therapy.
- As the community pharmacy or institution pharmacy, your pharmacists or pharmacy technicians are responsible for the dispensing and final check of the prescription.
- If purchasing narcotic, controlled, or targeted drugs from the selling pharmacy (outside of an emergency situation or shortage), you must verify that the selling pharmacy also holds a Controlled Drugs and Substances Dealer’s Licence.
- Your pharmacy may only dispense these compounded or repackaged drugs to your pharmacy’s own patients pursuant to a valid patient-specific prescription. You may not resell these drugs to a third party (e.g., medical or veterinary clinics or other pharmacies).
- These requirements must be met even if both the recipient and selling pharmacies are owned by the same proprietor.
Selling compounded or repackaged drugs
Does your pharmacy sell compounded or repackaged drugs to another pharmacy? If so, the licensee and pharmacy team must ensure the following:
- Your pharmacy holds a valid compounding and repackaging licence.
- The recipient pharmacy holds a valid community pharmacy licence or is an institution pharmacy. A compounding and repackaging licence does not enable sales to non-pharmacy entities (e.g., medical, dental, or veterinary clinics).
- You have an ACP-approved compounding and repackaging agreement in place that is current and signed before selling compounded or repackaged products to the community or institution pharmacy.
- If selling narcotic, controlled, or targeted drugs to other pharmacies (outside of an emergency situation or shortage), your pharmacy also holds a Controlled Drugs and Substances Dealer’s Licence.
- Your pharmacy may only sell these compounded or repackaged drugs to the community or institution pharmacy for the community or institution pharmacy’s own patients. The community or institution pharmacy must have a valid patient-specific prescription. You may not sell drugs to a community or institution pharmacy for subsequent resale to a third party (e.g., office use in a medical clinic or another pharmacy).
- These requirements must be met even if both the selling and recipient pharmacies are owned by the same proprietor.
Verifying pharmacy licences
To check any pharmacy’s licence type, you can refer to the ACP website. We have recently added a new feature to the “Find a pharmacy” tool on the website’s homepage to check pharmacy licence types. Now, when you search a pharmacy, you can see the pharmacy’s licensure category to verify if the pharmacy holds a community, compounding and repackaging, and/or mail order licence.
New pharmacy licences
If you require a compounding and repackaging licence, refer to the ACP website for more information. The ACP compounding and repackaging agreement was updated in May 2022. If you have not signed a new agreement since this date, ensure you update your contract with the selling or recipient pharmacy.
