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Practice Resources - July 29, 2021

Standards of Conduct for Personnel Involved in Compounding Sterile Preparations

The National Association of Pharmacy Regulatory Authorities (NAPRA) receives queries from time to time from individuals seeking clarity on the content of NAPRA’s compounding standards. Among the more common are questions related to the standards of conduct for personnel involved in compounding sterile preparations, particularly the obligation to remove all cosmetics.

Compounding of sterile preparations is recognized as a practice that carries significant risk. Compounding personnel are expected to implement consistent high-quality standards that ensure preparation quality and safety. Both the NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and the NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations require compounding personnel to follow all pertinent policies and procedures, among which is the requirement that personnel remove all cosmetics, including makeup, false eyelashes, perfume, hair products such as hairspray, henna tattoos and paper tattoos, prior to entering the anteroom. This is an extremely important step as these products can generate particles that are possible sources of contamination.

When inquiring about the compounding standards, it is always best to contact the pharmacy regulatory authority (PRA) in the appropriate province or territory for more information on compliance with the standards in that jurisdiction. The PRAs may have additional information to provide about whether or not particular situations may be acceptable in their respective jurisdictions.

A list of pharmacy regulatory authorities in Canada can be found on the NAPRA website.