U.S. Food & Drug Administration (FDA)

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to expand its legal authority over veterinarians and veterinary compounding pharmacies in its newly released “Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances,” (#256) as announced on November 19, 2019.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

As previously described, FDA has updated its Draft Guidance for Industry, #120, regarding the Veterinary Feed Directive Regulation.

The intersection of federal and state law impacted by this regulation is interesting.

Specifically, what is the impact to a veterinarian when the Veterinarian-Client-Patient relationship as defined by the relevant state law (governing that veterinarian’s license)

FDA recently released an edited version of its previously released guidance on the Veterinary Feed Directive Regulation fashioned as questions and answers.  (See Guidance #120).

Some of the edited and added Q&A will be discussed in future blogs, but the list of the edited and newly added questions, delineated in the table of

Some happenings at USDA and FDA that may impact your business are noteworthy.

On November 16, 2018 FDA released for public comment “proposed research to validate an alternative approach for bioequivalence studies for certain animal drugs.”

Bioequivalence studies are required before drugs are approved by FDA (for humans or animals) as safe and efficacious.

The

The Food Animal Residue Avoidance Databank (FARAD) recently provided guidance to small ruminant producers and their veterinarians in an article titled “Extralabel drug use (ELDU) in small ruminants” in JAVMA, Vol 253, No. 8, Oct. 15, 2018, pp 1001-1009.

FARAD is a university-based national program that serves as the primary source for scientifically-based recommendations

State Departments of Emergency Management prepare and respond to natural disasters by implementing the orchestrated emergency response plans, which state, federal and non-profit partners help develop over the years. These plans, that also include responses to the intentional or accidental introduction of highly pathogenic zoonotic or strictly animal diseases, are considered ever-green and updated based

As part of its Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings—just released—FDA announced that it plans to shift from “educating” food animal veterinarians and producers about the 2016 Veterinary Feed Directive (VFD) to “ensuring compliance with the . . . regulation to further ensure the safety of animal and human health.”  In