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Letters of the law: VFD, Rx and OTC

Who decides which medications will require a veterinary feed directive (VFD), prescription (Rx) or be available over-the-counter (OTC)?

That’s in the hands of FDA or, more specifically, FDA’s Center for Veterinary Medicine.[1]

VFD medications are antimicrobials deemed medically important to humans that are permitted for use in or on animal feed.[2] As of January 2017, they will require a VFD from a licensed veterinarian for use in food animals. Product labels will clearly indicate which ones require a VFD.

If at least one VFD medication is in a combination — for instance, one medication in an approved combination is a VFD product and another is an OTC medication — a VFD is still required.

So when is a Rx needed? All medically important antimicrobials to be administered in the drinking water of food animals will require a prescription from a licensed veterinarian. This rule also kicks in January 2017.

No Rx will be required for OTC feed medications that are not considered medically important, such as bacitracin.

 

 

 

 

 

[1] #120 Guidance for Industry Small Entity Compliance Guide Veterinary Feed Directive Regulation Questions and Answers. FDA. http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf Accessed December 15, 2015.

[2] Veterinary Feed Directive Requirements for Veterinarians. FDA. http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455416.htm  Accessed December 15, 2015.

 

 

 


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