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Updates to FDA Guidance for Industry #256
Updates to FDA Guidance for Industry #256

Learn more about upcoming guidance for Compounding Animal Drugs from Bulk Drug Substances

Jenna Killian avatar
Written by Jenna Killian
Updated over a week ago

Beginning April 1, 2023, new FDA GFI (Guidance For Industry) 256 requirements will go into effect, impacting the availability of compounded medications for office use and adding new requirements for writing prescriptions for compounded medications. Certain affected Wedgewood compounds will be available for patient-specific prescription only, and may require submission of a medical rationale.

What is GFI 256?

GFI 256 is new FDA guidance that impacts access to office use orders for some compounded medications. For more information on FDA GFI 256 and what this means for your veterinary practice, please reference the following resources provided by Wedgewood:

What Will I See On Vetcove?

For clinics that place orders through shop.vetcove.com, you can expect to see messaging displayed on the item listings of affected Wedgewood compounds that will provide guidance on this change.

While you will still be able to view Wedgewood listings for these products, you will no longer have the ability to add them to cart on the Vetcove site, but rather, will be prompted to create a patient-specific prescription on https://order.wedgewoodpharmacy.com/.

For further questions regarding this change, you may reach out to the Wedgewood team at hello@wedgewoodpharmacy.com.

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