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Is your practice ready to comply with FDA’s new Guidance starting October 1, 2022?

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.]

We have adapted our ordering and prescribing systems and are training our staff to comply with this new Guidance. Is your practice ready, too?

  •  69% of your colleagues, in our recent survey, said that they are not confident (24%) or not at all confident (45%) that their practices are prepared to comply with the provisions of the GFI #256.

Here are three things you can do today to be ready for compliance with GFI #256.

Take stock.

Review the compounded medications you stock and frequently prescribe to determine if and how you will need to change treatment protocols related to the requirements of the Guidance.

  •  65% of your colleagues have not done this and only 7% have plans to do so; 20% say they’re not sure if this has been done.

For example, are the medications you stock for office use on a regular basis currently on one of the FDA’s lists of Bulk Drug Substances (BDS) that are approved or being reviewed for use in compounding for office use? Are any on the not approved list? Bottom line: you may need to begin prescribing some medications for individual patients. This step may require someone on your staff to consult FDA’s lists, which change frequently. See our resource page for this and other information.

Ready your rationale. 

Develop policies and procedures for how you will document your clinical rationales for prescribing a compounded medication for an individual patient instead of an FDA-approved drug.

  • 72% of your colleagues have not done this, 18% aren’t sure if they have, and only 5% have specific plans for doing so.

All our prescribing channels are ready to assist you in documenting clinical rationale. We are working with the third-party vendors that submit prescriptions from veterinarians to our systems to ensure that they integrate smoothly with us. This includes both for orders directly on our own systems and those placed through third-party vendors, for example, providing simple drop-down boxes you can use to indicate your clinical rational for prescribing a compounded medication.

Get ready to report.

GFI #256 requires that you report adverse events and product defects to FDA using FDA form 1932A or an electronic tool.

  • 70% of your colleagues have not developed policies and procedures for how they will report adverse events as specified in the Guidance; 17% aren’t sure if they have, and only 6% have specific plans to do so.

  • What’s next?

    Contact Wedgewood Pharmacy:

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