United States Food and Drug Administration. Repackaging of certain human drug products by pharmacies and outsourcing facilities, 2017. https://www.fda.gov/downloads/Drugs/Guidances/UCM434174.pdf. AccessedMay17, 2020.)| false
NIOSH List of antineoplastic and other hazardous drugs in healthcare settings, 2016. Publication number 2016-161. https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf?id=10.26616/NIOSHPUB2016161. AccessedMay17, 2020.)| false
United States Food and Drug Administration. Compounded drug products that are essentially copies of a commercially available drug product under section 503a of the federal Food, Drug, and Cosmetic Act guidance for industry. 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf. AccessedMay17, 2020.)| false
United States Department of Labor. Occupational Safety and Health Administration. Hazard communication: Small entity compliance guide for employers that use hazardous chemicals. https://www.osha.gov/Publications/OSHA3695.pdf. Accessed May 17, 2020.
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 and <800> Hazardous Drugs—Handling in Healthcare Settings4 as well as all the other chapters that are referenced in those three 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.
Your subscription allows you to download updates throughout your subscription year. Be sure to do that each February, June, and November so you have the most current versions of existing chapters and any new General Notices, General Chapters, or monographs that were completed in the prior months.
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. A proposed revision was published in 2019 but was appealed and returned to the USP Compounding Expert Committee to evaluate and/or revise.5
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-GL Healthcare, the Pharmacy Compounding Accreditation Boards, and others can include it in their own standards.