On September 23, 2019, USP issued a statement explaining that they are postponing the official dates of the revised <795> Pharmaceutical Compounding - Nonsterile and <797> Pharmaceutical Compounding – Sterile Preparations, and the new general chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing and Repackaging, until further notice. The implementation date for USP <800> is not affected. In the interim, the current official chapters of <795> and <797> remain official.
USP <795>, <797> & <825>
The revisions to <795> and <797> as well as the new chapter <825> were published in June of 2019. After publication, USP received appeals on certain provisions in all three chapters. In accordance with USP’s formal appeals process, stakeholders who submitted appeals on the compounding chapters have requested further review by an appointed Panel. USP’s Bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending.
General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health.
USP plays no role in enforcement. State and other regulators may make their own determinations regarding the enforceability of <800>. Please consult with your regulatory body to ensure compliance.
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- Proposed Revision of General Chapter <797> Pharmaceutical Compounding – Sterile Preparations is now Posted and Open for Comments
- USP <800> Refrigerator Frequently Asked Questions Answered
USP remains committed to advancing public health and to promoting the quality of compounded preparations and the safe handling of hazardous drugs. USP will continue to communicate updates on the compounding chapters and the appeals process.