The U.S. Food and Drug Administration (FDA) announced this week the successful implementation of guidance for industry (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.” GFI #263 was introduced in draft in 2019 and the final guidance published in June 2021 and outlined a two-year timeline for animal drug sponsors to transition products to prescription status.
FDA shared that all affected animal drug sponsors opted…
