GFI 263 Resource Center
Welcome to the OTC to Rx (GFI #263) resource center
Animal Health International is committed to connecting you with the resources you need to stay informed. Here you will find pertinent information for businesses that will be affected by this change. We aim to help the transition of antimicrobial drugs from over the counter (OTC) to prescription (Rx).
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Frequently asked questions
By June 11, 2023, the FDA expects all affected antibiotics currently being sold through the OTC channel to display the following statement on the label: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” Once the label claim has adjusted, an antibiotic will only be sold or dispensed through a licensed veterinarian or dispensed pursuant to a valid order from a veterinarian.
I use some of these antibiotics, but not for cattle or pigs. Will I still need a prescription?
Yes – a prescription is required, regardless of species.
How can I guarantee that I still have access to these antibiotics?
You will need to work with a veterinarian, who will issue a prescription after a veterinarian-client-patient-relationship (VCPR) is established. Contact your local veterinarian to learn more about the requirements of a VCPR.
What will happen with OTC stock that transitioned to Rx – what do we do with the product?
The FDA Center for Veterinary Medicine (CVM) has stated they “do not intend to recall OTC-labeled product that entered distribution channels before June 11, 2023. CVM acknowledges that products may have multiple labels in circulation for a period of time until the old OTC-labeled product depletes. To that extent, CVM expects that the products will be used according to the label’s marketing status:
- CVM will not object if OTC-labeled products that entered distribution channels before June 11, 2023, continue to be sold and used as OTC until such products have depleted. Timelines for depletion may vary but should be consistent with normal sales volume and expiration dates for a given product.
- New Rx-labeled product should be used only by or on the order of a licensed veterinarian.”
Resources from our manufacturer partners
Shortened timeline of FDA action on antimicrobial resistance
List of approved new animal drug applications:
- Oxytetracycline, Polymyxin B
- Penicillin G Procaine, Novobiocin
- Dihydrostreptomycin, Penicillin G Procaine
- Penicillin G Procaine
- Penicillin G Benzathine, Penicillin G Procaine
- Cephapirin Benzathine