As previously reported in NGFA E-Alert, the Food and Drug Administration (FDA) on June 28 announced a 60-day extension -- to Aug. 27 -- in the deadline for submitting comments on potential modifications and improvements to its veterinary feed directive (VFD) program.
A task force of the NGFA's Feed Legislative and Regulatory Affairs Committee currently is in the process of developing the NGFA's comments on improvements that could be made to what currently is an overly cumbersome and costly VFD process that focuses most of the responsibility and regulatory burden on commercial feed manufacturers.
The VFD process for restricted feed-use drugs was authorized by Congress in 1996 when enacting the Animal Drug Availability Act. Prior to that, the only two options that existed for dispensing animal drugs were over-the-counter and prescription, the latter of which involved compliance with complex and burdensome state pharmacy laws that apply to human drugs and included a requirement to have a licensed pharmacist on site.
The VFD is a written statement issued by a licensed veterinarian in the course of his or her professional practice that orders the use of a VFD drug to treat the client's animals, but only in accordance with the directions for use approved or indexed by FDA. Two VFD drugs have been approved thus far by FDA: tilmicosin, which is authorized for controlling swine respiratory disease; and florfenicol, which is authorized for controlling swine respiratory disease, control of mortality attributable to enteric septicemia in catfish and control of mortality in freshwater-reared salmonids caused by coldwater disease.
VFD drugs are Class II animal drugs requiring that feed mills mixing them be licensed to manufacture Type B or C medicated feeds from a VFD drug Type A medicated article. Currently, before mixing feeds containing such drugs, feed manufacturers are required to obtain from a licensed veterinarian a paper, fax or electronic version of the VFD; for faxed or emailed copies, an original version signed by the veterinarian is required to be obtained by the feed mill within five working days thereafter, unless such VFDs are electronically generated, transmitted and stored in accordance with the agency's onerous 21 CFR Part 11 regulations that govern official electronic communications.
Among other things, the NGFA's comments plan to oppose expanding the use of VFDs to apply to a broader range of antibiotics already approved by FDA for use in feed as a way to address the agency's concern over whether the nontherapeutic use of such products in food-producing animals contributes to the development of antimicrobial resistance in humans to the same drugs when used to treat human illness. The NGFA also plans to offer specific recommendations for making the existing VFD process more efficient, including: 1) eliminating the current requirement that a valid VFD specify the quantity of feed required to treat animals; 2) eliminating the requirement that an original, signed copy of VFDs received electronically be obtained by the feed mill within five business days after issuance; 3) reducing to one year the records-retention requirement for VFD forms maintained by both feed manufacturers and distributors; and 4) eliminating the requirement that distributors who ship animal feed containing a VFD drug to another consignee or distributor obtain an acknowledgement letter affirming that the subsequent party has complied with distributor-notification requirements in FDA's VFD regulations.
The NGFA welcomes additional input from feed manufacturers on problems experienced with the current VFD process; please contact NGFA Director of Feed Services David Fairfield at dfairfield@ngfa.org, or by calling 712-243-4035. You may click here to access FDA's Federal Register notice requesting comments on the VFD process.