New FDA guidance addresses medically important antimicrobials

Published on June 11, 2021
Hands place a label on an orange bottle of antimicrobial pills

Manufacturers have two years for transition from OTC to Rx

The U.S. Food and Drug Administration (FDA) has released new guidance to facilitate veterinary oversight of all animal antimicrobial drugs considered medically important in treating people.

The final guidance from the FDA Center for Veterinary Medicine outlines a two-year implementation period beginning today—June 11, 2021—for animal drug manufacturers to voluntarily change marketing status of the affected drugs from over-the-counter (OTC) to prescription (Rx). Products in the marketplace during this transition time might have either an OTC or a Rx label.

These drugs are used mostly in food-production settings, but the guidance also may impact companion animal practitioners. The majority of affected drugs are injectable products. The full list also includes tablets, boluses, intra mammary, oral solutions, pump actuated sprayer, and egg dip solutions.

The guidance, known as GFI #263, is part of the FDA’s five-year action plan for supporting antimicrobial stewardship in veterinary settings. 

AVMA’s commitment to antimicrobial stewardship

It’s essential that antimicrobials remain available to use to care for animals. Requiring a veterinary prescription for all medically important antimicrobials used in animals should help foster antimicrobial stewardship in all veterinary settings. The AVMA will work with the FDA to facilitate this transition process in a way that minimizes impacts on animal health.

The FDA has provided answers to questions animal owners might ask. Please antimicrobialsatavma [dot] org (email the AVMA) if you have further questions.


Approve with concerns

I am entirely behind this proposal. Only concern would be for rural areas where antimicrobials may become more difficult to obtain.

Add New Comment

Restricted HTML

  • Allowed HTML tags: <a href hreflang> <em> <strong> <cite> <blockquote cite> <code> <ul type> <ol start type> <li> <dl> <dt> <dd> <h2 id> <h3 id> <h4 id> <h5 id> <h6 id>
  • Lines and paragraphs break automatically.
  • Web page addresses and email addresses turn into links automatically.
Please verify that you are not a robot.