Who must authorize the use of medically important antibiotics under Guidance 213?

Who must authorize the use of medically important antibiotics under Guidance 213?

• A. A licensed veterinarian
• B. Farm owner
• C. FDA Center for Veterinary Medicine only
• D. Pharmacist

Answer: (A)

Under Guidance 213, use of medically important antibiotics in food-producing animals must be overseen by a licensed veterinarian who has an established veterinary-client-patient relationship. This veterinarian is responsible for diagnosing the condition, determining the appropriate indication, dose, and treatment duration, and ensuring proper withdrawal times. The farm owner cannot authorize medical use on their own, and while a pharmacist can dispense the medication, they do so only under a veterinarian’s order. The regulatory agency sets the policy, but it is the veterinarian who provides the clinical authorization for use.

Under Guidance 213, use of medically important antibiotics in food-producing animals must be overseen by a licensed veterinarian who has an established veterinary-client-patient relationship. This veterinarian is responsible for diagnosing the condition, determining the appropriate indication, dose, and treatment duration, and ensuring proper withdrawal times. The farm owner cannot authorize medical use on their own, and while a pharmacist can dispense the medication, they do so only under a veterinarian’s order. The regulatory agency sets the policy, but it is the veterinarian who provides the clinical authorization for use.