FDA seeks comments on feed directive process
The Food and Drug administration is seeking comments and reviewing veterinary feed directive regulations in response to complaints that the directive process is burdensome.
"In addition, there are concerns that the process in its current form will become particularly problematic to administer in the future as the number of approved VFD animal drugs increases," a March 29 Federal Register notice states.
Veterinary feed directive drugs are those that can be used in animal feed but only with a licensed veterinarian's supervision and a valid veterinarian-client-patient relationship.
A veterinarian who determines that use of an animal feed containing a VFD drug is indicated must fill out and sign an approved form with information about himself or herself, the client, the animal or animals to be treated, the disease, and the drug to be used. The veterinarian, the client, and the feed supplier are all required to keep copies of the form for at least two years.
The FDA has approved the use of two drugs—both antimicrobials—as VFD drugs. Tilmicosin has been approved as a VFD drug for swine, and florfenicol is approved for use in swine, catfish, and salmonids. Extralabel use of any medicated feed is prohibited.
Comments are due by June 28. To submit a comment online, go to www.regulations.gov and search for the docket number, FDA-2010-N-0155.
Submissions can also be faxed to 301-827-6870 or mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The submissions need to include the docket number.