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Sterile and non-sterile compounding inspections to continue this summer

April 14, 2021
All pharmacies must meet all three priorities of the compounding standards by July 1, 2021. 

The deadline for pharmacies to comply with all three priorities of the NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous and Hazardous Sterile Preparations and ACP’s Standards for Pharmacy Compounding of Non-sterile Preparations is July 1, 2021. All pharmacies must meet Level A non-sterile compounding requirements. Those providing higher levels of non-sterile compounding or sterile compounding must additionally meet the requirements of the type and level of compounding being provided.

The detailed requirements for all three priorities are listed on the sterile compounding page and the non-sterile compounding page on the ACP website.

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.

For the sterile compounding inspection, your pharmacy will be required to show evidence of each of the required elements including direct observation by the pharmacy practice consultant (PPC) and sterile compounding assessor of hand hygiene and garbing and aseptic technique, and review of documentation (e.g., cleaning logs, preparation logs, policies and procedures). Pharmacy licensees will receive 30 days’ advance notice of the scheduled sterile compounding inspection.

Thereafter, all pharmacies that perform sterile compounding will be inspected once every three years at minimum. Those pharmacies that perform high-risk sterile compounding will be inspected once every 18 months at minimum. Any re-inspections required will be determined by the PPC and the sterile compounding assessor and may incur a reinspection fee.

Also note that with our inspections to date, ACP has noticed deficiencies with maintaining regular certification of equipment. Remember, verification of your equipment and environment must continue at a minimum of every six months.