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News & Press: National News

USP Postpones <797>, <795>, and <825>

Monday, September 23, 2019   (0 Comments)
Posted by: Jeff Rochon
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On September 23, 2019, USP notified stakeholders that it is postponing the effective dates of published revisions to <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations, as well as a new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging.

After publication of the revised and new compounding standards, USP received appeals on certain provisions in <795>, <797>, and <825>.

In accordance with USP’s Bylaws, the responsible Expert Committees worked with a sense of urgency to consider the information raised in the appeals and issued decisions on the appeals (see Decisions on Appeals to USP <795> and <797> and <825>). 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. Therefore, USP is postponing the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice.

In the interim, the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) including the section Radiopharmaceuticals as CSPs will remain official.

In addition, due to the pending appeals, USP new general chapter <800> (Hazardous Drugs Handling in Healthcare Settings) will remain official. 

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 states that <800> is only informational, will not be applicable until the appeals process is complete and 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>. 

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