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FDA has finalized GFI #256,
Animal Drugs from Bulk Drug Substances, and it is slated to be enforced
beginning October 1, 2022. [Extended by FDA to April 2023.] This Guidance means that some of the ways
veterinarians order compounded medications will change, including what can be
ordered for office use and what will require a patient-specific prescription.
There are also additional documentation requirements for veterinarians,
including determining a clinical rationale and adverse event reporting.
Almost all medications prepared by Wedgewood Pharmacy and our Wedgewood Connect
outsourcing facility are compounded using Bulk Drug Substances (BDS) because
that is best pharmacy practice and the most scientifically sound way to ensure a
consistent, quality compounded medication. In short: we have a vested interest
in ensuring that we, and thus our veterinary customers, comply with the new
guidelines established by GFI #256.
We make it easy for our veterinary customers to comply with the new guidance.
We have world-class information technology systems in place. These ensure that
when our customers order or prescribe from us, through any channel, we comply
with the Guidance, state, laws, regulations, and codes that apply to compounded
medications. For example, we know which 14 states limit ordering for office use
and what those limits are. When veterinarians order or prescribe a compounded
medication from us, they can rest assured that compliance with GFI #256 (and all
other applicable laws, rules, and regulations) is built into our systems—and our
We have invested heavily in adapting our ordering and prescribing systems to
the new guidelines in GFI #256. For example:
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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.