Are you ready for VFDs? |
Fish farmers, feed companies urged to prepare
for using next generation of in-feed antibiotics
Fish farmers, veterinarians and feed mills in the freshwater salmonid industry need to start familiarizing themselves with regulations governing the use of what the U.S. Food and Drug Administration calls Veterinary Feed Directive (VFD) drugs.
“The VFD process is not a complicated matter, but it will be important for everyone in the freshwater-reared salmonid industry to know and understand the FDA’s rules,” says Dr. Richard Endris of Schering-Plough Animal Health Corporation.
The first VFD drug for aquaculture, Aquaflor (florfenicol), was approved for use in catfish last year. Aquaflor, a fast-acting, broad-spectrum antibiotic developed specifically for use in veterinary medicine, is expected to be approved for use in freshwater salmonids — trout, arctic char and freshwater life stages of saltwater fish like salmon — in the near future.
Why VFDs?
FDA established the VFD drug classification to more closely control new therapeutic products — primarily antimicrobials — and their use in food animals. The new classification applies only to new in-feed therapeutics approved by the FDA after 1999 and administered in feed. All products approved before 1999 have maintained their over-the-counter status.
“The VFD allows us to continue adding new drugs to our health tool box,” stresses Richard Sellers of the American Feed Industry Association.
Like catfish farmers, producers of trout and other freshwater salmonids will be able to obtain VFD drugs through normal feed-distribution channels, but they must first obtain a signed Veterinary Feed Directive from a licensed veterinarian.
He adds that the VFD regulations were developed by a coalition of members in the animal health community to better control new therapeutic, antimicrobial drugs. The system aims to reduce antibiotic resistance and prolong effectiveness of new antimicrobials through judicious use.
The first VFD drug to be classified and approved by the FDA since the approval of VFD status was tilmicosin, an antimicrobial for swine respiratory disease. Aquaflor became the second antibiotic in the animal health industry and the first in aquaculture to be given this exclusive status when it was licensed last fall.
How it works
The starting point for obtaining feed with a VFD drug is with the producer experiencing sick fish. Producers can get a VFD order from a diagnosing veterinarian or veterinary laboratory as long as there is what the FDA calls a “veterinarian-client-patient relationship” with the producer or hatchery manager. With the VFD form in hand, the producer can go to the feed mill to order and obtain the VFD-containing feed.
Sellers notes that the VFD order authorizes the client to obtain the medicated feed in accordance with the directions for use approved by the FDA. There is no “extra-label” or “off label” use for any VFD drug, meaning it can be ordered only for the use specified on the product label.
Responsibility for compliance falls on the feed mills, veterinarians and producers. “A VFD drug means some additional paperwork, but it’s not a big deal,” acknowledges Sellers. “The VFD form needs to be completed by a vet and everything must be legal, valid and correct before the feed mill can fill that VFD order.
“Most feed mills serving the aquaculture industry have been through the federal medicated feed licensing process, so I'm confident they know what they're doing,” he adds.
Feed mills already holding a medicated feed mill license simply need to file a notification letter with the FDA stating its intention to distribute an animal feed containing a VFD drug. All VFD orders must be retained by the feed mill for a period of two years.
Short learning curve
Dr. Dave Erdahl, fisheries biologist and branch chief of the Aquatic Animal Health Drug Approval Partnership Program of the U.S. Fish and Wildlife Service, Bozeman, Mont., doesn’t think the VFD process will be a major issue for most producers raising trout and other freshwater-reared salmonids.
“The role of veterinarians in aquaculture is expanding,” he says. “There are already a considerable number of operations working directly with consulting veterinarians or veterinarians on staff with state and federal agencies.
“Like anything new, it will likely be a bit problematic at first,” he adds, “but I look at the VFD process as a ‘growing pain’ for our industry. If we want new products to maintain fish health, we have to get with the program. It’s that simple.”
Dr. Patricia Gaunt, associate professor, aquatic animal health, Mississippi State University College of Veterinary Medicine, says the VFD classification has not proved to be a big issue for producers or feed mills in the catfish industry
“There is always a learning curve in any new situation,” Gaunt says of the VFD drug process, “but the rewards of a new drug to treat aquatic disease certainly justify the learning process.
“We're also approaching the education process through diagnostics with the farmer when they bring in diseased fish and we explain the VFD process to them,” she adds.
Growers with questions on the VFD process should contact their diagnostic lab, extension service, veterinary college or veterinarian. Information about VFDs and VFD forms is also available at www.aquaflor-usa.com.