Since January 2017, as a result of the successful implementation of Guidance for Industry (GFI) #213, medically important antimicrobials administered in the feed or drinking water of food-producing animals are only available for use through a licensed veterinarian. However, a limited number of other dosage forms (e.g. injectables) of approved medically important antimicrobials remain available over-the-counter (OTC).  All new animal drug applications on the list below have been identified as medically important antimicrobial drugs that currently remain approved as over-the-counter products.

The listed applications are affected by GFI #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.”  The  voluntary process outlined in this guidance is part of FDA’s broader efforts to support antimicrobial stewardship and slow the development of antimicrobial resistance.

GFI #263 has a two-year implementation period that begins June 11, 2021. In addition, the FDA plans to engage with affected stakeholders and state partners at public events, such as meetings and conferences, to hear feedback and answer questions about the guidance.