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GFI #256 is real and complicated. We make compliance simple.

FDA’s GFI #256 is here. It’s real. It’s different. We’re here to help.

FDA has finalized GFI #256, Compounding 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.

Here are three facts veterinarians will want to know about GFI #256.

The rules are complicated, but we make compliance simple.

  • FDA has established four dynamic lists that define which BDS in which forms may or may not be used to compound for office use for different species. We are constantly monitoring these lists. We also are leading the industry charge to nominate drugs to ensure that the medications our customers and their patients need are being placed on a positive list by FDA. (If you are responsible for long-term inventory management for one or more practices, you may want to become familiar with the FDA’s lists. Don’t worry: you’ll find links to all of the lists and other resources in our GFI #256 resources center.)
  • For medications made from BDS prescribed for individual patients pursuant to a prescription, veterinarians will be required to specify that there is a clinical difference supported by a medical rationale for why the compounded medication is needed instead of an FDA-approved drug. FDA has provided easy-to-understand examples. We’ll make specifying a medical rationale easy in our prescription tools.
  • Veterinarians also will be required to report adverse events and product defects to FDA using a specific form or electronic tool. We’ll provide the form and links to the tool.

We have you covered. We will ensure you are informed and prepared for compliance.

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 psyches.

Change can be difficult. We’re committed to helping veterinarians navigate in the new GFI #256 environment.

We have invested heavily in adapting our ordering and prescribing systems to the new guidelines in GFI #256. For example:

  • When a prescriber is required to determine a clinical difference supported by a medical rationale for a prescription of a compounded medication, we will prompt them to make this determination, along with a list of typical justifications.
  • We also have provided intensive training to our Customer Care professionals and sales professionals so they can guide our veterinary customers to make sound, compliant choices.
  • Yes, there may be some surprises and disruptions to “business as usual,” as all of us to adapt to the guidance. But Wedgewood Pharmacy is committed to help our customers get it right, and make it easy, every time.

What’s next?

Contact Wedgewood Pharmacy:

GFI #256 is real and complicated. We make compliance simple.