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USP Publishes Notice of Intent to Revise New Compounding Standards

Health & Life Sciences Alert Brenda M. Maloney Shafer, Cory J. Kopitzke

On September 23, 2019, the United States Pharmacopeial Convention (USP) published a Notice of Intent to Revise its new compounding standards, initially released on June 1, 2019. The new standards were to become effective on December 1, 2019. However, USP received appeals on certain provisions in <795>, <797>, and <825>, and its expert committees issued decisions on those appeals on August 16, 2019. Stakeholders who submitted appeals have now requested further review by an appointed Panel. According to USP’s bylaws, the effective date of a standard under appeal must be postponed while the appeal is pending. Therefore, parties should continue to comply with the currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) including the section Radiopharmaceuticals. Importantly, General Chapter <800> will still become official on December 1, 2019.

The North Carolina Board of Pharmacy has already posted a response to the notice. California has issued a statement via email:

"The California State Board of Pharmacy acknowledges the recent USP announcement regarding postponement of the official dates of revised USP Chapters 795 and 797 and new USP Chapter 825 [uspnf.com]. While the timing of USP Chapters is unknown at this time, it is the Compounding Committee’s intention to continue its efforts to evaluate regulations necessary to ensure safe compounding practices consistent with the board’s consumer protection mandate. The timing of board regulations will be determined after additional information is provided by USP."

We will continue to monitor for additional state updates.

If you have questions regarding compliance with USP Compounding standards, please contact your Quarles & Brady attorney or: