Medically Important Antimicrobials in Animal Agriculture

Sponsored by the Agricultural and Food Law Consortium

 Topic:

This webinar will include an overview of the 2015 Veterinary Feed Directive rule and FDA’s current thinking on the use of medically important antibiotics in food-producing animals. The 2015 Veterinary Feed Directive rule went into effect on 1 October 2015. (See 80 FR 31708, 3 June 2015)  In 1996 the U.S. Congress passed the Animal Drug Availability Act (Public Law 104-250) defining a veterinary feed directive drug as “A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 512(b) to use under the professional supervision of a licensed veterinarian is a veterinary feed directive drug. Any animal feed bearing or containing a veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian’s professional practice. When labeled, distributed, held, and used in accordance with this section, a veterinary feed directive drug and any animal feed bearing or containing a veterinary feed directive drug shall be exempt from section 502(f).”

The Center for Veterinary Medicine at FDA has published guidance on the veterinary feed directive rule and the use of medically important antibiotics in food-producing animals, including:

  • # 120:    FINAL: Veterinary Feed Directive Regulation Questions and Answers
  • # 152:    Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
  • # 181:    Guidance for Industry Blue Bird Medicated Feed Labels
  • # 209:    The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
  • # 213:    New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209
  • # 233:    Veterinary Feed Directive Common Format Questions and Answers

 

Participation:

 

This webinar was recorded on May 18, 2016.  To listen to a recording of the webinar, click here.

Presenter:

 Dr. Michael Murphy

Veterinary Medical Officer, CVM/FDA

Dr. Murphy received his B.S., D.V.M., and Ph.D. degrees from Texas A&M University, College Station, Texas, in 1980, 1981, and 1987, respectively. He received his J.D. from William Mitchell College of Law, St. Paul, MN, in 1999. He is board certified by the American Board of Veterinary Toxicology and American Board of Toxicology.  After practicing in a mixed animal practice in northeastern Oklahoma, he served as a clinical and diagnostic veterinary toxicologist in the Texas and Minnesota Veterinary Diagnostic Laboratories for 27 years. As a faculty member at the University of Minnesota he taught veterinary and graduate students and conducted applied research. He retired from the University of Minnesota as a Professor Emeritus and joined the Center for Veterinary Medicine at FDA in 2009.

While at CVM/FDA, Dr. Murphy has assisted in jurisdiction, drug recall and shortage analyses, responses to litigation and citizens petitions, and policy associated with cloned or genetically engineered animals, and antimicrobial resistance. He has most recently assisted on the veterinary feed directive rule.

 

Research & Materials:

Presentation

References and additional reading material

State or Federal VCPR

Brochures for:

                Veterinarians

                Producers

                Distributors