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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
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.”
Read the appeal decision.
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This content is intended for counseling purposes only. This content is informational/educational and is not intended to treat or diagnose any disease or patient. No claims are made as to the safety or efficacy of mentioned preparations. The compounded medications featured in this content have been prescribed and/or administered by prescribers who work with Wedgewood Pharmacy. You are encouraged to speak with your prescriber as to the appropriate use of any medication. Wedgewood Pharmacy’s compounded veterinary preparations are not intended for use in food and food-producing animals. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.