As of January 1, the FDA’s Guidance for Industry (GFI) 213 has been fully implemented. This means medically important antibiotics used in feed are no longer labeled for production purposes such as growth promotion or feed efficiency. While compliance with GFI 213 was voluntary, all affected drug sponsors agreed last year to change or remove those labels from their products.
Producers need to be aware that off-label use of medicated feeds is illegal. Feed-grade antibiotics labeled for prevention, control or treatment of disease remain available, but under the new veterinary feed directive (VFD) rules, which also took effect with the New Year, producers need to work through their veterinarian to obtain a VFD order for those products deemed medically important. The VFD order, filed by the veterinarian, includes information on reason for use, dosage duration and animals to be treated, and that information must comply with the product label.
Medically important antibiotics delivered in water now require a veterinarian’s prescription.
On December 23, 2016, the FDA released three Federal Register documents to update the Code of Federal Regulations reflecting changes to most of the new animal drug applications affected by GFI 213. As of January 3, 2017, all affected drug applications have either aligned with the recommendations outlined in GFI 213, or their approvals have been voluntarily withdrawn.
Of the 292 new animal drug applications initially affected by Guidance for Industry #213:
· 84 were completely withdrawn.
· 93 applications for oral dosage form products intended for use in water were converted from over-the-counter to prescription status.
· 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status.
· Production indications were withdrawn from all 22 applications that included such indications for use.
Moving forward, the FDA intends to focus its efforts on issues including:
· Align antimicrobial drug products with the principles of antimicrobial stewardship in veterinary settings.
· Support efforts to foster stewardship of antimicrobials in veterinary settings.
· Assess the impact of strategies intended to curb the emergence of antimicrobial resistance associated with the use of antimicrobial drugs in veterinary settings.