In June of 2021, the U.S. Food and Drug Administration made final Guidance for Industry #263 (GFI #263). The new FDA livestock antibiotic regulation explains the process for changing the marketing status of certain antimicrobial drugs from over-the-counter to Rx.
The FDA allowed for a two-year implementation period, so the pet and livestock antibiotics on the list will become Rx medications by June of 2023. Some drug manufacturers made the change earlier, and consumers may have had trouble sourcing certain animal antibiotics as a result.
Why the FDA Made This Change
The FDA implemented GFI #263 as part of a broader plan to reduce the instances of antimicrobial resistance, which is a threat to both animals and humans. Requiring certain antibiotics for cattle, horses, swine, and pets to be dispensed only when authorized by a veterinarian minimizes unnecessary or inappropriate uses of the drugs.
Consumers will still have access to the same antibiotics for livestock, horses, and pets. The difference is that the medicines included in GFI #263 will now require approval by a licensed veterinarian.
What You Should Do Now
Now is the time to start planning to ensure your access to needed medications for pets and livestock continues. If you don’t already have an established veterinarian-client-patient relationship (VCPR), develop one now.
Once the change takes effect, the included antibiotics for horses, livestock, and pets will only be available through a licensed veterinarian, so ordering them without a VCPR will not be possible.
List of Affected Medications
The FDA’s livestock antibiotic regulations affect the following drugs:
- Cepharin
- Cepharin Benzathine
- Chlortetracycline
- Dihydrostreptomycin
- Erythromycin
- Gentamicin
- Lincomycin
- Novobiocin
- Oxytetracycline
- Penicillin G Benzathine
- Penicillin G Procaine
- Polymyxin B
- Spectinomycin
- Sulfabromomethazine
- Sulfachlorpyridazine
- Sulfadimethoxine
- Sulfamethazine
- Sulfomyxin
- Sulfisoxazole
- Tylosin
Allivet offers several of the pet, swine, horse, and cattle antibiotics affected by this change, including:
- Tylan 50 InjectionTerramycin Ophthalmic Ointment
- Durvet Penicillin Injectable (Penicillin G Procaine)
- Tylan 200 Injection
- Duramycin 72-200 (Oxytetracycline)
- Noromycin 300 LA (Oxytetracycline)
- ToDay
- ToMorrow
- Liquamycin La-200
- Terramycin Scours Tablets
- Lincomix Injectable
- Albadry Plus
If you have questions about whether a particular pet or livestock antibiotic medication is affected by GFI #263, ask your veterinarian, or contact Allivet’s customer service department at 877.500.9944.
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