How USP’s Proposed and Changes May Complicate Patient Care A Briefing for Providers • January 20, 2022 Background The United States Pharmacopeia is the agency that sets standards for drug substances, including for compounded medications. USP is not a regulatory agency; it’s a standard-setting body. But FDA and most state Boards of Pharmacy adopt and enforce USP standards in federal and state regulation, and so USP standards in effect serve as the foundational regulatory framework for pharmacy compounding across America. On September 1 , 2021, USP published revised proposed Chapters 795 and 797, which deal specifically with non-sterile and ...
WA Pharmacy Quality Assurance Commission 2020 Responsible Pharmacy Manager Pharmacy Self-Inspection Worksheet USP 795 – Nonsterile Compounding Addendum ATTENTION: Responsible Pharmacy Manager Washington law holds the responsible manager and all pharmacists on duty responsible for ensuring pharmacy compliance with all state and federal laws governing the practice of pharmacy. Failure to complete this report within the month of March or within 30 days of becoming responsible manager (as required by WAC 246-945-005) may result in disciplinary action. The following addendum is required to be filled out and kept on file with the General Pharmacy Self-Inspection Worksheet. Do not send to ...
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