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FDA Guidance #263

Have you heard that "the rules are changing" for purchasing antibiotics on June 11, 2023? While it's true that the rules are changing with the implementation of FDA's Guidance #263, here's what you really need to know and how it may (or may not) affect you: What's Changing:

  • As of June 11, 2023, both small and large animal owners will need a veterinary prescription to purchase medically important antibiotics.

  • Antibiotics will have to be purchased from a licensed pharmacy and can no longer be purchased over the counter (OTC). This means that feed stores must be licensed veterinary retail facilities and employ licensed veterinary dispensing technicians to accept prescriptions.

How will this be enforced:

  • Starting June 11, 2023, drug manufacturers must label all medically important antibiotics as "prescription" with an official Rx statement.

  • Existing inventory of OTC-labeled products that are already in distribution channels (i.e. already in stock at feed stores) can be legally sold as OTC products until inventory is depleted.

What's needed to obtain a prescription:

  • A current Veterinary-Client Patient Relationship (VCPR)! This means that you have a veterinarian who has worked with your animals and/or visited your operation within the past year.

  • If you have an existing VCPR then you are unlikely to notice any changes after June 11, 2023.

  • Producers who do not have a valid VCPR are encouraged to seek out and establish one with a trusted veterinarian who can help you optimize the health and performance of your herd.

Which drugs will go from OTC to Rx? Penicillin (Penicillin G Procaine, Penicillin G Benzathine)

  • Injectable

  • Intramammary tubes

Oxytetracyclines

  • Injectables: Liquamycin LA-200, Noromycin 300 LA, Biomycin-200, Agrimycin, etc.

  • Boluses: Terramycin Scours Tablets, OXY 500 Calf Boluses

Sulfa-based Antibiotics (Sulfadimethoxine, Sulfamethazine)

  • Injectables: Di-Methox 40%, SulfMed 40%

  • Boluses: Albon, Sustain III Cattle & Calf Boluses, Supra Sulfa III Cattle and Calf Boluses

Tylosin

  • Injectables: Tylan 50, Tylan 200

Cephapirin, Cephapirin Benzathine

  • Intramammary tubes: ToDay and ToMORROW

Lincomycin (pigs)

  • Injectables: Lincomix 100, Lincomix 300, LincoMed 100, LincoMed 300

Gentamicin (pigs)

  • Injectables: Garasol, Gentamicin Piglet Injection

- Emily Gosda, VMD


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