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March 8, 2023

The FDA will be enforcing GFI 263 on June 11

FDA policy will impact antimicrobial products
Effective June 11, 2023, the FDA will be enforcing GFI 263, which outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx).

This legislation is a result of the FDA’s efforts to combat antimicrobial resistance (AMR) by promoting the judicious use of medically important antimicrobials in animals.

As a result, products you order today as OTC may require a prescription from a veterinarian to be purchased and used as of June 11.

List of products impacted by GFI #263

The MWI Animal Health team is ready to ensure you’re ready for this change and have the products you need when you need them.

We recommend reviewing the FDA’s materials regarding GFI 263, including:

GFI #263: Frequently Asked Questions for Farmers and Ranchers
GFI 263 Final Guidance Document
If you have questions regarding how your purchases from MWI may be affected by GFI 263, please contact your sales representative.