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Compounding standards compliance deadline approaching

June 9, 2021
All three priorities must be met by July 1, 2021.

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 three weeks 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.

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 patient needs; however, your pharmacy still must 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. 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 to ensure the safety and integrity of the products you provide to your patients before entering into a compounding and repackaging agreement.

Compliance with all three priorities of both the sterile and non-sterile compounding standards will be assessed through an ACP in-person inspection. Note that some digital evidence will be requested prior to inspection. These inspections will continue beyond July 1, 2021.

NOTE: This article was updated on May 18, 2022, to link to new versions of the compounding and repackaging agreement form.