The deadline for pharmacies to comply with priority three of the Standards for Compounding Non-Hazardous and Hazardous Sterile Preparations and the Standards for Pharmacy Compounding of Non-sterile Preparations is July 1, 2021. The third priority requires pharmacies to have proper facilities and equipment in place to perform compounding activities. For many pharmacies, renovations will be necessary to meet the standards. Pharmacies not equipped to meet Level B or Level C compounding requirements (as defined in the standards) may choose to enter into an agreement with a compounding and repackaging pharmacy.
This is a reminder that licensees must apply to ACP to make physical changes to a pharmacy, including renovations to meet the compounding standards. Before any physical changes are made, licensees are required to complete the renovation application process.
The renovation application process includes licensees completing the renovation application form, providing a complete floor plan for the entire pharmacy, as well as paying the renovation application fee. Licensees must submit a floor plan that complies with the floor plan requirements guide found on the ACP website. If you have already completed renovations to your pharmacy without previously applying to the college, you still must complete ACP’s renovation application process. Remember, when an ACP pharmacy practice consultant visits your pharmacy, your pharmacy must exactly match the floor plan you provided to ACP.
Also, if you intend to add pharmacy services (e.g., provision of compounding and repackaging services to another pharmacy or mail order pharmacy services) and plan to make physical changes to your pharmacy to accommodate these new services, you must first apply for an additional licence category by completing the add-on form AND complete the pharmacy renovation application process.
Please keep the following key points in mind when planning changes to your pharmacy:
- All pharmacy services, including storing, compounding, dispensing, and selling of drugs, must only occur within the dispensary of a licensed pharmacy.
- Adding a room to your pharmacy is a renovation. If you are considering a room that is not directly connected to your dispensary to accommodate the requirements of the non-sterile compounding standards, you need to apply for a secondary dispensary through the renovation application process. Only a pharmacy that does not have a compounding and repackaging licence AND existed at its current location before March 3, 2018, is eligible to apply for a secondary dispensary.
- Repurposing a room (e.g., intending to compound in a room that is currently being used for patient consultations) is a renovation and requires a renovation application because the size of the dispensary and layout of the pharmacy are changing.
- Changing the infrastructure (e.g., installing a fume hood) in your dispensary is considered a renovation as the physical facilities have changed.
Renovations will be inspected and must be immediately compliant with all three priorities of the compounding standards.
For more information on applying for a renovation, visit the Changes that require ACP approval page on the ACP website.