The July 1 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 less than two months away. Is your pharmacy ready?
The compounding standards and accompanying guidance and resources were developed to enhance patient and pharmacy team safety, and the quality and safety of compounds.
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. Any changes to the physical facilities, proposed use of space, or layout of a licensed pharmacy are considered renovations and require advanced notice and approval by the registrar prior to implementing these changes.
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 obtain the compounds they are not able to prepare. It is one way to meet the standards and meet the patient needs; however, your pharmacy still needs to be equipped to compound Level A preparations. 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 been licensed and authorized by ACP. 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.
Remember, sterile and non-sterile compounding inspections will continue beyond the July 1, 2021, compliance deadline.
NOTE: This article was updated on May 18, 2022, to link to new versions of the compounding and repackaging agreement form.