The deadline to comply with priority three of ACP’s Standards for Pharmacy Compounding of Non-sterile Preparations and Standards for Compounding Hazardous and Non-hazardous Sterile Preparations is July 1, 2021.
The compounding standards and accompanying guidance and resources were developed to enhance patient safety, the effectiveness of compounds, and the safety of pharmacy teams who compound
Pharmacies should already be compliant with priority one (Assessing risks and gaps) and priority two (Compounding and cleaning, personnel training, and quality assurance). If your pharmacy hasn’t already met the third priority (facilities and equipment), it should be working towards compliance to meet the deadline. Investing in infrastructure will not only allow your pharmacy to be compliant with the standards, it will also improve patient safety, staff safety, and the quality of the compounded products your pharmacy prepares.
While pharmacies should strive for compliance of all three priorities on their own, some pharmacies are choosing to enter into compounding and repackaging agreements to outsource the preparation of compounds they are not able to complete. It is one way to meet the standards and meet the needs of their patients. If you choose to enter into a compounding and repackaging agreement with another pharmacy, do not wait until July 2021—it is best to find a compounding and repackaging pharmacy now.
Pharmacies intending to provide compounding and repackaging services to other pharmacies must first obtain a compounding and repackaging licence from ACP. Pharmacies should check to ensure that the pharmacy providing these services has this licence. Before entering into a compounding and repackaging agreement with another pharmacy, be sure to read our Link article from May 13, 2020. The article provides six key points to consider before entering into a compounding and repackaging agreement.
Perhaps the most important point to consider is to ensure the compounding and repackaging pharmacy is meeting the standards. Before you enter into an agreement, confirm that the compounding and repackaging pharmacy has
- a compounding and repackaging licence;
- proper policies and procedures in place;
- documented quality assurance processes;
- appropriate facilities and equipment for the compounds they are preparing;
- dedicated, clean spaces for compounding;
- trained, skilled, and knowledgeable compounding staff; and
- all other requirements identified in the standards.
If possible, contact the compounding and repackaging pharmacy to arrange a tour of their facility so that you can see first-hand whether the pharmacy meets both the standards and your expectations. This will help you be confident in the pharmacy’s services before entering into an agreement.
NOTE: This article was updated on May 18, 2022, to link to new versions of the compounding and repackaging agreement form.