1.1 Where can I find the full text of USP <795>?

USP publishes the USP Compounding Compendium.1 It contains all the major compounding chapters: <795> Pharmaceutical Compounding—Nonsterile Preparations,2 <797> Pharmaceutical Compounding—Sterile Preparations,3 <800> ­Hazardous Drugs—Handling in Healthcare Settings,4 and <825> Radiopharmaceuticals—­Preparation, Compounding, Dispensing, and Repackaging5 as well as all the other chapters that are referenced in those core compounding chapters. Additionally, the General Notices that apply to compounding and compounding monographs are included. The Compounding Compendium is available through USP at www.usp.org as an annual subscription.

1.2 When did USP <795> become official?

USP <795> has been an official standard since 2004. It was previously revised in 2011 when USP <1075> Good Compounding Practices was incorporated into it and in 2014 to clarify the distinction between beyond-use dating of nonsterile and sterile preparations. Proposed revisions were published in 2019 and 2021 and received public comments. A revision was published in 2022 and is official as of November 1, 2023.

1.3 Is USP <795> a guideline? A requirement?

USP<795> is a minimum standard. Regulators such as federal or state entities can make it a regulation by including it in their documents. Accreditation organizations such as The Joint Commission, DNV Healthcare, The Accreditation Commission for Healthcare (previously, Healthcare Facilities Accreditation Program), Center for Improvement in Healthcare Quality, the Pharmacy Compounding Accreditation Boards, and others can include it in their own standards.