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USP 795 Nonsterile Compounding Compliance: Steps to Review, Renew, and Refocus

Download and share this guide from compounding compliance expert Dr. Annie Lambert on understanding USP <795> best practices and taking easy, actionable steps to achieve pharmacy compliance.  


Nonsterile compounding is a core function of the practice of pharmacy; all pharmacies are expected to follow USP and state regulations to ensure high quality and patient safety. Pharmacies compounding nonsterile medications have been required to follow USP <795> requirements since 2000. Many State Boards of Pharmacy have laws governing the act of compounding and more recently have adopted the USP <795> standards directly.


For the last twenty years, the Chapter has undergone multiple revisions incorporating new science and evidence-based guidance and best practices. However, enforcement of the Chapter standards has been inconsistent, drawing little attention from regulatory agencies and pharmacy leaders alike while other USP compounding chapters have taken precedence.


Because of these ongoing revisions and lack of regulatory scrutiny, many pharmacies have not yet developed a robust USP <795> compliance program. This guide, developed by Simplifi 797 compounding compliance expert Annie Lambert, PharmD, BCSCP, explains the USP <795> standards in detail, and provides actionable steps your facility can take to meet best practices and ensure successful regulatory inspection outcomes. 

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Simplifi 797 is a customizable, expert-developed automated solution that takes the effort out of USP , , and compliance. Optimize your operations and pass inspections with the only closed-loop compliance support on the market. More than 2,000 pharmacies trust Simplifi 797 for compounding compliance confidence.

Wolters Kluwer provides trusted clinical technology and evidence-based solutions that drive effective outcomes across healthcare. Specialized in clinical effectiveness, learning, research, and safety.

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Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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