USP 795 non sterile compounding
HealthJuly 27, 2021

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. 

Access the USP <795> Compliance Guide
Annie Lambert
Clinical Program Manager for Compliance Solutions
Compliance Solution Clinical Program Manager Annie Lambert, PharmD, BCSCP is committed to providing up-to-date USP content and expert compliance guidance, and to work with you to optimize the use of our solutions.
Solutions
Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.