FDA Issues Guidance #263 Recommending That Animal-Approved Over-The-Counter Medially Important Antimicrobial Drugs Are Required To Be Overseen By Veterinarians Before Sale And Use.

Fox Rothschild LLP

Fox Rothschild LLP

FDA has continued to exercise its authority, via guidance documents, which FDA says, while not legally enforceable, represent the agencies current thinking on the topic.  To further the judicious use of medically important antimicrobial drugs in animals, the goal of Guidance #263 is to:

(1) Limit medically important antimicrobial drugs to uses in animals that are considered necessary for assuring animal health, and

(2) Limit medically important antimicrobial drugs to uses in animals that include veterinary oversight or consultation.

“FDA intends to work with affected drug sponsors to help them to voluntarily change the marketing status of their medically important antimicrobial new animal drug products from OTC to Rx.”

Certainly, animals benefit from examination, diagnosis and treatment plans from licensed veterinarians, but there are numerous veterinary deserts throughout the country in which access to licensed veterinarians can be difficult.

This occurs even in otherwise populated states, including New Jersey, where a recent proposed bill, A5117, would provide load redemption for certain eligible veterinarians who work at approved underserved sites for specified times.  As proposed,

The Secretary of Agriculture, in consultation with the New Jersey Horse Council, the New Jersey Association of Equine Practitioners, and the New Jersey Farm Bureau, shall annually establish a list of State designated veterinary underserved areas.

A veterinarian participating in the federally administered Veterinary Medicine Loan Repayment Program would not be eligible to participate in this NJ state program.

Additional hurdles that animal owners face, if in veterinary deserts, are the state veterinary practice acts which generally require veterinarians to be licensed in each state in which they are diagnosing and treating animals.  With a dearth of veterinarians serving rural areas, farmers and ranchers may experience additional hurdles to providing adequate care to their animals if they have to rely on state-licensed veterinarians.

In Guidance #263, FDA outlines the process for “sponsors of approved applications and abbreviated applications for new animal drugs containing medically important antimicrobials for use in non-food (companion), food-producing animals, or both, that are currently approved with over-the-counter marketing status . . . to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status.”

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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