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New pharmacies must comply with all compounding standards

May 27, 2020

Priorities one, two, and three of the non-sterile and sterile compounding standards must be met prior to opening.

Due to the additional stresses placed on pharmacy teams during the COVID-19 pandemic, ACP extended the deadline for pharmacies to meet the third priority of the college’s Standards for the pharmacy compounding of non-sterile preparations to July 1, 2021. This will give pharmacies the time necessary to meet the priority, which focuses on having the necessary facilities and equipment in place for the types of compounding being performed at the pharmacy.

Despite this extension, it is important to note that all new pharmacies must meet all three priorities of both the non-sterile and sterile compounding standards before opening. In other words, a new pharmacy must fully comply with the standards to pass its pre-opening inspection.

As stated in ACP’s Foundational Requirements: Guidance document for opening a licensed community pharmacy (Requirement #12), a new pharmacy must have a dedicated space for compounding drugs that complies with the college’s non-sterile compounding standards.

The Foundational Requirements document states the following: “The requirements for non-sterile compounding are based on the complexity and risks associated with compounding the preparation and handling the substances used to make the preparations. It is necessary to examine many factors in assessing the risk associated with using a certain substance and determining the appropriate level of requirements. Pharmacists should undertake a risk assessment and identify the appropriate level of requirements needed to guarantee a high-quality product and adequate protection for personnel.”

For more information on opening a pharmacy, refer to ACP’s Five Steps to Opening Your New Pharmacy.

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