FDA Regulation: Final Rule on Veterinary Feed Directive

 

As of October 1, 2015, the Veterinary Feed Directive (VFD) was revised to regulate the use of antibiotics that are medically important in the treatment of food animals. The new implementation will require veterinary supervision with the use of all medically important feed grade antibiotics used in food-producing animals. Although the original Veterinary Feed Directive document was signed in 1996, the newly expanded regulation is set to go into full effect by December 2016. The VFD final rule provides a way to strategize and implement veterinary supervision while ensuring the use of antibiotics in food-producing animals is judicious and compliant with consumers’ needs. 

So, what is a Veterinary Feed Directive drug? It is a “drug intended for the use in or on animal feed which is limited by:

  • an approved new animal drug application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act,
  • a conditionally approved application filed pursuant to section 571 of the Act, or
  • an index listing pursuant to section 572 of the Act to use under the professional supervision of a licensed veterinarian.”[1]

Antibiotics affected by the regulation include: Neomycin, Tylosin, Chlortetracycline, Oxytetracycline, Virginiamycin and Terramycin, among others. Since Neomycin and Terramycin are commonly used additives on dairy farms to treat calf scours, it is likely that farmers with young calves will be most affected by the latest FDA regulation. By December 2016, farmers will be required to have a VFD form to purchase and use any additives or products containing Neomycin and Terramycin in their feed.

Veterinary Feed Directive forms, which are similar to prescriptions, must be obtained by producers from a licensed veterinarian prior to the purchase and use of any related antibiotics. Only veterinarians with a veterinary-client-patient relationship may issue a VFD form. The forms may not be issued over the phone, but electronic forms sent via email or fax will be accepted. Copies of the VFD form must be kept by all parties including the veterinarian, farmer, and feed distributor for a minimum of two years; and the expiration date on the form is not to exceed six months. VFD forms will include detailed information specifying the farm, animals being treated, antibiotic(s) used, feeding rates, and the exact duration of the treatment.

The VFD fosters increased veterinary oversight on farms while ensuring that VFD drugs are used in or on feed and in accordance to label directions, while simultaneously meeting animal health requirements. What’s next? Once the regulation is implemented in full swing in December 2016, it will no longer be legal to use medically important antibiotics for production purposes. Producers will be required to obtain a VFD form from their veterinarian and may only use the antibiotics for prevention, control or treatment of specific diseases.

For more information on the parameters of each role associated with the Veterinary Feed Directive, please visit http://www.regulations.gov.

 

[1] 21 CFR 558.3(b)(6). See also “Center for Veterinary Medicine.” Guidance for Industry Small Entity Compliance Guide Veterinary Feed Directive Regulation Questions and Answers, p.6. 30 September 2015. Web. 09.Nov. 2015.

 

CALT does not provide legal advice. Any information provided on this website is not intended to be a substitute for legal services from a competent professional. CALT's work is supported by fee-based seminars and generous private gifts. Any opinions, findings, conclusions or recommendations expressed in the material contained on this website do not necessarily reflect the views of Iowa State University.

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