FAQs for Upcoming Animal Antibiotic Changes, GFI #263
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
What animal health products ARE NOT changing? GFI #263 does NOT include preventative vaccines used in your vaccine protocols. Animal vaccines are still available without a prescription.
In addition, GFI #263 does NOT include implants, vitamins or dewormers. These commonly used products are still available OTC, without a prescription.
Visit the FDA website for the full list and other details.
How Do I Get Animal Antibiotics After June 11, 2023? Can Livestock Producers Access the Same Meds They’ve Always Used?
News Flash...OTC labeled antibiotics are still (after June 11, 2023) in stock and available for sale at PBS Animal Health. Check our website often or call our Customer Care Specialists for availability, expiration dates and status on product inventory. Keep checking, keep asking about availability of OTC labeled product inventory. OTC labeled product in stock is ready to purchase and ship to your door promptly, so don't wait.As far as access to the same medications (once current OTC labeled antibiotic inventories are depleted and labeling changes occur), yes, livestock producers will still have access to these same products – but with a prescription. At that time, a veterinarian's prescription will be required, GFI #263, to purchase these key medical antibiotic products. This means you will need a prescription for the specific product from a veterinarian with whom you have established a veterinarian-client-patient-relationship (VCPR). If you do not have a VCPR with a veterinarian, do not delay in obtaining one.
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. To help make the process even faster and easier, our pharmacist will call your vet for you – simply provide us with your veterinarian's name and phone number and we will contact the vet promptly.
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 OTC labeled products as long as they are available (and within expiration date).Please don’t assume that you can’t buy these products after June 11, 2023. OTC labeled antibiotic inventory may be available and in the distribution channel. We encourage you to check our website often or call us for availability on OTC labeled antibiotics. We will sell OTC labeled inventory (within expiration date) until it is gone. If you find it available, purchase it promptly.
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.
