With the approval of the first veterinary feed directive (VFD) animal drug for use in an aquaculture species, a coalition is forming with the American Feed Industry Association’s leadership to amend the minor species Compliance Policy Guide (CPG) created by FDA to allow producers to utilize medicated feed labeled for one species in a minor species. “Minor species” are those species other than cows, pigs, chickens, turkeys, dogs, cats or horses. This would include fish, goats, rabbits and other species of significantly less sales when compared to major species. The minor species CPG for medicated feed can be found here.
AFIA is working with the Animal Health Institute (AHI), American Veterinary Medical Association (AVMA) and National Aquaculture Association (NAA) to review, discuss and amend, if possible, the CPG created by FDA in 2001 to allow veterinarians to create an order that FDA would recognize to allow minor species producers to purchase and use a medicated feed labeled for another species. This CPG expresses FDA’s regulatory discretion policy for use of medicated feed in an extra-label manner. Although the Animal Medicinal Drug Use Clarification Act of 1994 expressly prohibits extra-label drug use of animal drugs in medicated feed, FDA created this CPG to detail when the agency would use its regulatory discretion to allow such use in minor species. AFIA supports the CPG process and use detailed therein.
The CPG says a veterinarian may write an order for a minor species animal producer to use a medicated feed in an extra-label manner if there is no other drug for that purpose; its use is for therapeutic purposes; the feed is labeled for the approved species; and the order is maintained by the producer for FDA review. In this CPG, the feed mill must regularly stock this type of feed; it must be labeled and manufactured with the correct approved animal drug for the intended species; and it must be used in a similar species (e.g. catfish and trout or cow and goat). The feed mill does not have to maintain a copy of the order given to the producer by the veterinarian.
This CPG would allow aquaculture producers access to a wider range of animal drugs provided there is a veterinarian/patient/client relationship and the medicated feed will only be used at the producer’s location, for limited feeding to relieve animal suffering and disease. It would define how future VFDs could be used in an extra-label manner.
AFIA VP Richard Sellers believes that forming this coalition to discuss the approach will allow approved VFD animal drugs the same level playing field for minor species use, as it allowed for over-the-counter medicated feed when it was created. He says, “It’s the next step in the evolution of this CPG.”
Pursuing this change has become a policy of AVMA. AHI and AFIA are working to develop some additional guidelines to overcome the hurdles required by the VFD regulations, such as the requirement for a lawful VFD form with the legal species listed. Initial discussions with FDA’s Center for Veterinary Medicine (CVM) about its concerns are positive, and AFIA will hold coalition meetings, develop amendments and hold subsequent meetings with CVM officials to discuss potential amendments. This process will likely take a year.
For more information on the process or this CPG, contact Sellers at rsellers@afia.org.
