USP to Delay Official Implementation of Updates to Compounding Chapters 795 and 797
The United States Pharmacopeia (USP) released information earlier this fall stating their decision to delay the official implementation of published revisions to general chapters 795 (non-sterile compounding) and 797 (sterile compounding). They additionally will be delaying the implementation of a new chapter associated with radiopharmaceutical compounding (chapter 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. In light of these appeals, USP is postponing the official dates of the revised <795> and <797> and the new chapter <825>.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.
Because of the interaction between the new chapter 800 (hazardous drug compounding) and the updates to chapters 795 and 797 the USP also made the following statement.
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>. 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.
It is important to remember as stated that USP itself is not a regulatory agency. USP provides standards that require enforcement via state and federal agency established statute or rule.
You should always understand your state Pharmacy or Veterinary Licensing Boards’ requirements related to the practice of veterinary medicine. If you have questions your state veterinary medical association is an excellent resource for regulatory information.