The Food and Drug Administration’s Center for Veterinary Medicine (CVM-FDA) in its 2021 guidance, will fully implement the regulation of currently approved over-the-counter (OTC) animal antibiotics to prescription-only status by June 2023.
The measure supports antimicrobial stewardship and prevents, if not, slows down the rate of microbial resistance to antibiotics. Its primary objective is to reduce the concerns about the overuse or misuse of medicines.
Under the latest guidance, all medically important antibiotics in dosage forms such as injectable, intra-mammary, and boluses, approved for use in food and companion animals, will be made available on June 2023 via veterinary prescription only, including:
- Tylosin
- Penicillin
- Tetracycline
- Sulfadimethoxine/Sulfamethazine
- Cephapirin/Cephaphirin benzathine
- Lincomycin and Gentamicin (swine antibiotics)
Vaccines, de-wormers, injectable and oral nutritional supplements, ionophores, pro/prebiotics and topical non-antibiotic treatments, however, will remain accessible OTC.
Effective on June 11, 2023, the FDA directed that labels of the remaining 4% of medically important antibiotics currently marketed as OTC products must be updated to read: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
Moreover, veterinary-client-patient relationships (VCPR) will be required to access such antibiotics. A valid VPCR may vary from state to state, but specific competencies and conditions will be set in place, fully allowing veterinarians to make a medical judgment, prescription, and medication instructions that pet or livestock owners must follow.
In Texas, livestock owners are encouraged to seek trusted veterinarians as early as possible. In some cases, the inability to access a large animal veterinarian hinders farmers’ ability to care for and obtain prescriptions for their cattle and other farm animals. Many farmers are concerned about how this guidance will negatively impact the health of their animals.
“While most people prefer not to worry about future problems until it’s time, time is running out before the guidance is enforced. “So, it’s recommended that [livestock] owners who don’t already have a good relationship with a trusted veterinarian start seeking one out and establish that relationship now because you’re going to need that VCPR to make sure you have access to those antibiotics when you need them.”, said Tracy Tomascik, Texas Farm Bureau (TFB) Associate Director.
Here at AIV, we are strong advocates for antimicrobial stewardship and we're dedicated to assisting veterinary facilities with medical equipment to ensure the safety of drug administration for animals. Our commitment to high-quality products and services comes in the following:
For more information about the guidance, read here.