Animal & Veterinary

Drugs Transitioning from Over-the-Counter (OTC) to Veterinary Feed Directive (VFD) Status

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This list represents the antimicrobials approved for use in or on animal feed affected by GFI #213. The complete list of affected applications will continue to be updated as changes are made and can be located here.

Upon completion of their voluntary transition from OTC to VFD, all feed uses of the following drugs, alone and in a combination, will require a VFD as of January 1, 2017, except in cases where a sponsor chooses to voluntarily withdraw the drug application:

Drugs Transitioning From OTC to VFD Status

Established drug nameExamples of proprietary drug name(s)$
chlortetracycline (CTC)Aureomycin, CLTC, CTC, Chloratet, Chlorachel, ChlorMax, Chlortetracycline, Deracin, Inchlor, Pennchlor, Pfichlor
chlortetracycline/sulfamethazine*Aureo S, Aureomix S, Pennchlor S
chlortetracycline/sulfamethazine/penicillin*Aureomix 500, Chlorachel/Pficlor SP, Pennchlor SP, ChlorMax SP
hygromycin BHygromix
lincomycinLincomix
oxytetracycline (OTC)TM, OXTC, Oxytetracycline, Pennox, Terramycin
oxytetracycline/neomycin*Neo-Oxy, Neo-Terramycin
penicillin+Penicillin, Penicillin G Procaine
sulfadimethoxine/ormetoprim*Rofenaid, Romet
tylosinTylan, Tylosin, Tylovet
tylosin/sulfamethazine*Tylan Sulfa G, Tylan Plus Sulfa G, Tylosin Plus Sulfamethazine
virginiamycinStafac, Virginiamycin, V-Max

Note: apramycin, erythromycin, neomycin (alone), oleandomycin+, sulfamerazine, and sulfaquinoxaline are also approved for use in feed and are expected to transition to VFD status, but are not marketed at this time. If they return to the market after January 1, 2017, they will require a VFD.

$Type A medicated articles used to manufacture medicated feed, all products may not be marketed at this time

*Fixed-ratio, combination drug

+Currently only approved for production uses

Current VFD Drugs

Established drug nameProprietary drug name(s)**
avilamycinKavault
florfenicolAquaflor, Nuflor
tilmicosinPulmotil, Tilmovet
tylvalosinAivlosin

**Type A medicated articles used to manufacture medicated feed

This information is up-to-date as of January 19, 2016. As the industry transitions, CVM anticipates additional changes during the coming months to this information. Please check the link below for the most recent updates:
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

Page Last Updated: 08/08/2016
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