GFI #263 FAQs
FAQs for Upcoming Antibiotic Changes
As part of the US Food and Drug Administration's (FDA) effort to combat antimicrobial resistance (AMR), it is changing the status of many over-the-counter (OTC) medications to now require a prescription (Rx). The FDA says AMR is a “serious threat to animal and public health” and veterinary oversight can help slow the development. However, this is a major change that will impact the way producers acquire the drugs they use to care for their livestock. Here’s what you need to know about the upcoming change.
What is GFI #263?
Guidance for Industry (GFI) #263 is from the FDA Center for Veterinary Medicine regarding changes that affect certain OTC animal medications. By June 11, 2023, drugs containing medically important antimicrobials that are marketed as OTC medications must transition to Rx status. It means these drugs must begin using the following statement on the label: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” With this new labeling, farmers and producers can only buy the antibiotic with a prescription from their vet. However, they are free to purchase from either the vet or their preferred animal pharmacy.
Which Animal Medications Transition to Rx?
The transition of OTC to Rx status will affect the following items:
- 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
Can Producers Access the Same Meds They’ve Always Used?
Yes, you can still access your preferred antibiotic but instead of purchasing them as desired from vendors like PBS Animal Health without a prescription, you will first need to have a prescription for the specific product from a veterinarian with whom you have established a veterinarian-client-patient-relationship (VCPR).
What If I Don’t Have a Veterinarian?
If you don’t already have a veterinarian-client-patient-relationship (VCPR) established, now is the time to secure one.
How to Order Prescriptions from PBS Animal Health
After your vet prescribes the antibiotic, and you place your order with us, PBS Animal Health handles the rest.
How PBS Animal Health Can Help
The FDA Center for Veterinary Medicine says products that use the OTC label (and have entered distribution channels before June 11, 2023) may be sold and used OTC after the transition deadline. This means they don’t intend to recall products with OTC packaging and that you can still purchase those products as long as they are available.
Don’t assume that you can’t buy these products now or after June 11 – if we have OTC labeled products in stock, we will sell them until they’re gone.
Don’t assume that you can’t buy these products now or after June 11 – if we have OTC labeled products in stock, we will sell them until they’re gone.
Change is Hard. PBS Animal Health Makes it Easier.
PBS Animal Health is here for you and your antibiotic needs thru this transition from OTC to RX. And remember, we’ve got you covered with a team of pharmacists who will call the vet on your behalf, both before and after the changes go into effect. Click here for a printable list of the popular products that move to Rx status in June, and contact us at email@pbsanimalhealth.com or call us at +1 (800) 321-0235. if we can help answer any other questions.
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