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OTC Antibiotic Changes

Guidance for Industry (GFI) #263 is part of a broader effort by FDA to combat antimicrobial resistance (AMR), a serious threat to animal and public health. Antimicrobial use in humans, animals, and horticulture can contribute to the development of AMR. Using antimicrobials judiciously, in all settings, can help slow the rate at which AMR develops.

Labeling changes as a result of GFI #263 are one example of how we can assist farmers and ranchers to strengthen their stewardship efforts when using these drugs.

Although specific requirements vary by state, veterinarians are generally not required to examine each individual animal for which a prescription is issued, as long as the veterinarian has established a valid VCPR with the farmer or rancher that owns or cares for the animal(s) in need of treatment.

Establishing a VCPR generally requires, among other things, that the veterinarian has become familiar with the management of the animals on a given farm or ranch by examining the animals and/or visiting the facility where the animals are managed.

Examples of affected products

  • Cephapirin, cephapirin benzathine

  • Intramammary tubes: ToDAY and ToMORROW

  • Gentamicin

  • Injectables: Garasol, Gentamicin Piglet Injection

  • Lincomycin

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

  • Oxytetracycline

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

  • Boluses: Terramycin Scours Tablets, OXY 500 Calf Boluses

  • Penicillin G procaine, penicillin G benzathine

  • Injectables: Penicillin Injectable, Dura-Pen, Pro-Pen-G, Combi-Pen 48, etc.

  • Intramammary tubes: Masti-Clear, Go-dry, Albadry Plus

  • Sulfadimethoxine, sulfamethazine

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

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

  • Tylosin

  • Injectables: Tylan 50, Tylan 200

*Newsletter March 2022 - Copyright ANDDA 2022

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