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USP Grants Compounding Pharmacies’ Appeal of Revisions to Compounding Rules
In June 2019, a coalition of compounding pharmacies, including Wedgewood Pharmacy, appealed proposed revisions to USP chapters <795> and <797> of the U.S. Pharmacopeia, which govern compounding of sterile and non-sterile preparations. The guidelines would have dramatically shortened the Beyond Use Dates (BUDs) of compounded preparations without any scientific evidence to support the changes, while discarding decades of established verification testing by compounding pharmacies that establish longer BUDs. The changes, slated to go into effect on December 1, 2019, would have disrupted patient access especially to sterile compounded medication, caused unnecessary interruptions of treatment for humans and animals, and increased the costs of compounded medicines.
On March 12, 2020 the Appeals Panel of the USP granted the appeal and remanded the two chapters to the Compounding Expert Committee “for further engagement with regards to the issues you have raised.”
Marcy A. Bliss, president and CEO said, “We will take advantage of the opportunity to have additional opportunities to work with the USP expert committee to ensure patient access to compounded medication, including adequate beyond use dates for sterile items.”