FDA To Transition Many OTC Animal Medications to Prescription

Antibiotic Changes from FDA to Fight Antimicrobial Resistance

The US Food and Drug Administration (FDA) is working to combat antimicrobial resistance (AMR). As part of this fight, the FDA will change the status of many over-the-counter (OTC) medications to require a prescription (Rx). AMR is a serious threat to animal and public health, and veterinary oversight can help slow its development.

However, this major change will impact the way producers acquire the drugs they use to care for their livestock. Here’s what you need to know about the FDA’s changes to OTC animal medications.

What is GFI #263?

Guidance for Industry (GFI) #263 from the FDA Center for Veterinary Medicine details changes to FDA guidance affecting OTC animal medications.

By June 11, 2023, drugs containing medically important antimicrobials marketed as OTC medications must transition to prescription status.

These drugs must now include following statement on the label: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

This new labeling means that farmers and producers can only buy these antibiotics with a prescription from their vet. They can still purchase from the vet or an animal pharmacy.

Which Animal Medications Transition to Rx?

The transition of OTC to Rx status affects the following medications: 

• Oxytetracycline
• Sulfisoxazole
• Oxytetracycline, Polymyxin B
• Sulfamethazine
• Sulfabromomethazine
• Erythromycin
• Tylosin
• Sulfadimethoxine
• Sulfomyxin
• Sulfachlorpyridazine
• Spectinomycin
• Lincomycin
• Chlortetracycline
• Penicillin G Procaine, Novobiocin
• Dihydrostreptomycin, Penicillin G Procaine
• Tetracycline
• Penicillin G Procaine
• Dihydrostreptomycin
• Penicillin G Benzathine, Penicillin G Procaine
• Gentamicin
• Cephapirin
• Cephapirin Benzathine

Visit the FDA website for the full list and other details.

Will I Still Be Able to Get The Medications I Need for My Animals?

Yes, you’ll still be able to buy your preferred antibiotic, but instead of purchasing them over-the-counter from Blain’s Farm & Fleet without a prescription, you’ll first need to have a prescription for the specific product from a veterinarian.

What If I Don’t Have a Veterinarian?

If you don’t have a veterinarian-client-patient-relationship (VCPR) established, now is the time to get one.

How to Order Prescriptions from BlainsRx!

Ordering medications for your animal is still easy and affordable with BlainsRx.com!

Visit BlainsRx.com to learn more!