Animal & Veterinary

Drugs Transitioning from Over-the-Counter (OTC) to Prescription (Rx) Status

Printer-friendly PDF

This list represents the antimicrobials approved for use in water 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 Rx, all uses of the following drugs will require a prescription from a veterinarian as of January 1, 2017, except in cases where a sponsor chooses to voluntarily withdraw the drug application:

Water Soluble Drugs Transitioning From OTC to Rx Status

Established drug nameExamples of proprietary drug name(s)
chlortetracyclineAureomycin, Aureomycyn, Chlora-Cycline, Chloronex, Chlortetracycline, Chlortetracycline Bisulfate, Chlortet-Soluble-O, CTC, Fermycin, Pennchlor
erythromycinGallimycin
gentamicinGaracin, Gen-Gard, GentaMed, Gentocin, Gentoral
lincomycinLinco, Lincomed, Lincomix, Lincomycin, Lincomycin Hydrochloride, Lincosol, Linxmed-SP
lincomycin/spectinomycin*Lincomycin S, Lincomycin-Spectinomycin, L-S, SpecLinx
neomycinBiosol Liquid, Neo, Neomed, Neomix, Neomycin, Neomycin Liquid, Neomycin Sulfate, Neo-Sol, Neosol, Neosol-Oral, Neovet
oxytetracyclineAgrimycin, Citratet, Medamycin, Oxymarine, Oxymycin, Oxy-Sol, Oxytet, Oxytetracycline, Oxytetracycline HCL, Oxy WS, Pennox, Terramycin, Terra-Vet, Tetravet-CA, Tetroxy, Tetroxy Aquatic, Tetroxy HCA
penicillinHan-Pen, Penaqua Sol-G, Penicillin G Potassium, R-Pen, Solu-Pen
spectinomycinSpectam
sulfadimethoxineAgribon, Albon, Di-Methox, SDM, Sulfabiotic, Sulfadimethoxine, Sulfadived, Sulfamed-G, Sulforal, Sulfasol
sulfamethazineSMZ-Med, Sulfa, Sulmet
sulfaquinoxalineS.Q. Solution, Sulfa-Nox, Sulfaquinoxaline Sodium, Sulfaquinoxaline Solubilized, Sul-Q-Nox, Sulquin
tetracyclineDuramycin, Polyotic, Solu/Tet, Solu-Tet, Supercycline, Terra-Vet, Tet, Tetra-Bac, Tetracycline, Tetracycline Hydrochloride, Tetramed, Tetra-Sal, Tetrasol, Tet-Sol, TC Vet

Note: apramycin, carbomycin/oxytetracycline*, chlortetracycline/sulfamethazine*, streptomycin, sulfachloropyrazine, sulfachlorpyridazine, and sulfamerazine/sulfamethazine/sulfaquinoxaline* are expected to transition to Rx status, but are not marketed at this time. If they return to the market after January 1, 2017, they will require a prescription from a veterinarian.

*Fixed-ratio, combination drug

Current Rx Water Soluble Drugs

Established drug nameExamples of proprietary drug names
tylosinTylan, Tylomed, Tylosin, Tylosin Tartrate, Tylovet

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/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/default.htm

Page Last Updated: 01/19/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English