Planning for compliance with the Standards for Pharmacy Compounding of Non-Sterile Preparations

November 28, 2018

The Standards for Pharmacy Compounding of Non-Sterile Preparations are now available to all pharmacists and pharmacy technicians. All existing pharmacies performing non-sterile compounding must meet or exceed the standards involving human factors, like policies and procedures, risk assessment, personal protective equipment (PPE), and additional training, by January 1, 2020. Other areas that may require structural changes or additional equipment have a compliance deadline of July 1, 2020. All new pharmacies must be in compliance with the standards for their pre-opening inspection.

The pharmacy licensee is responsible for overseeing the implementation of these standards, and each pharmacist and pharmacy technician is required to meet or exceed these standards when dispensing a non-sterile preparation.

To complement the non-sterile compounding standards and guidance document, ACP has prepared several additional documents (Getting started: Three priorities to prepare for non-sterile compounding and Non-sterile compounding essentials) that will assist pharmacy teams to prepare for implementation. Be proactive – consider all priorities initially as the implementation may take time, particularly if renovations are necessary. Discuss as a team your implementation plan and strategize on how you will divide the workload to meet the required deadlines.

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