CVM Seeks Ideas on New and Improved Regulation of Veterinary Feed Directive Drugs

April 8, 2010

By Susan J. Matthees

FDA's Center for Veterinary Medicine ("CVM") recently announced an advanced notice of proposed rulemaking (“ANPRM”) to solicit comments on possible changes to the current regulation for veterinary feed directive (“VFD”) drugs.
The VFD drug category was established in 1996 as part of the Animal Drug Availability Act (“ADAA”).  A VFD drug is defined as “new animal drug approved under” FDC Act § 512(b) or “listed in the index under section 572 of the act for use in or on animal feed.”  21 C.F.R. § 558.3(b)(6).   In 2000, CVM issued final regulations implementing the VFD drug provisions of the ADAA.  VFD drugs must be used under the professional supervision of a licensed veterinarian. 

Congress intended the VFD drug category to help make more drugs available for animals, but over the past 9 years CVM “has received a number of informal general comments that characterize the current VFD process as being overly burdensome.”  CVM also expressed concern that the program would “become particularly problematic to administer in the future as the number of approved VFD animal drugs increases.”  With these concerns in mind, CVM seeks comments on whether, and if so, how, to improve current regulations and promote efficiency.  CVM asks submitters to organize their comments into 7 distinct categories:

  • Conditions that must be met by veterinarians issuing a VFD;
  • What veterinarians must do with a VFD (e.g., disposition of original VFD and copies);
  • Records that must be kept related to the VFDs;
  • Notification requirements for distributors of animal feeds containing a VFD drug;
  • Additional recordkeeping requirements that apply too distributors;
  • Cautionary statements required for VFD drugs and animal feeds containing VFD drugs; and
  • Other.

Comments are due by June 28, 2010.

Categories: Drug Development