U.S. Food & Drug Administration (FDA)

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

FDA recently published Guidance #263 titled, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter,” which builds on earlier provided guidance to limit medically important drugs in food-producing animals. (Guidance #209 and Guidance #213).

As explained in

As a veterinarian, if a pet-owner comes to you with questions or concerns about the safety of hemp or CBD infused pet products, are you prepared to navigate the conversation?

Practicing veterinarians are subject to the regulation of several entities, both state and federal, including the FDA, the DEA, and their respective state veterinary and

by Matthew R. Bailey Originally Published 6:30 a.m. ET April 17, 2020 | Updated 7:06 a.m. ET April 17, 2020

Scientists are working on dozens of potential treatments and vaccines for the novel coronavirus and the disease it causes, COVID-19. Virtually all of them have one thing in common — they’re the product of animal

FDA has recently announced it is relaxing its enforcement of telemedicine for veterinarians under two federal provisions:  (1) when prescribing extralabel drug use; and (2) when prescribing medicate feed pursuant to the Veterinary Feed Directive.  Both generally require an initial physical examination of animals prior to such prescription.

FDA only enforces certain regulations governing a

Since we first published “FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs,” a number of impacted stakeholders have been expressing concern about the intended and unintentional consequences of FDA’s current approach.

First, as a result of widespread concern about the proposed guidelines, FDA will be extending the time to comment, previously scheduled

On November 25, 2019, FDA posted 15 warning letters from the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Drug Evaluation and Research (CDER) stating that certain products containing CBD were illegally labeled as dietary supplements and in many cases were also: unapproved new drugs, misbranded drugs, adulterated human foods, and

Without clear statutory authority, FDA has proposed to expand its legal authority over veterinarians and veterinary compounding pharmacies in its newly released “Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances,” (#256) as announced on November 19, 2019.

FDA continues to describe the use of certain compounded medications for animals as violations of

Beef producers and packers have been required for years to “identify hazard points and critical points during beef slaughtering, which is a necessary first step toward developing a hazard analysis and critical control point system to control meat contamination by Escherichia coli O157:H7.”  See R. Guyon, et. al, Hazard Analysis of Escherichia coli O157:H7 Contamination

On October 30, 2018, the U.S. Food and Drug Administration “announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission. The overall goal of the action plan is to ensure the safety