Medically important antibiotics in feed and water were removed from OTC channels when the Veterinary Feed Directive was implemented in 2017. The first phase of the VFD regulations did not address OTC antibiotics delivered via other methods like injectables, boluses and intramammary mastitis tubes.
. . . the FDA has issued a new directive to bring all OTC drugs under veterinary oversight.”
FDA’s June 2021 Guidance for the Industry #263 recommends that sponsors of medically important antimicrobial drugs voluntarily transfer them to prescription marketing status. This would include label language stating; Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source: Dairy Herd Management, April; 5, 2022. Link.
- Guidance #263 is slated for final implementation on June 11, 2023.
- Products unaffected by the change include ionophores; antiparaciticides; injectable and oral nutritional supplements; oral pro/prebiotics; and topical non-antibiotic treatments.
INSIGHTS:
- This phase will again raise questions about veterinarians’ capacity to service producers’ Rx requirements, including on-farm oversight to meet VCPR regulations.
- Producers will be legally required to obtain a prescription from a licensed veterinarian with whom the producer has a valid veterinary-client-patient relationship.
- OTC stores and dealers can still service the business if they can review veterinary authorized prescriptions and track refills of prescription products.