Catfish Industry Gets Ready for Using
Next Generation of In-Feed Antibiotics
UNION, N.J.— Catfish growers, veterinarians and feed mills 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 first of which is expected to be approved for catfish in 2005.
"It's not a complicated matter, but it will be important for everyone to know and understand the rules," says Dr. Dick Endris of Schering-Plough Animal Health Corporation, which is awaiting FDA approval of Aquaflor ® (florfenicol). Its active ingredient, florfenicol, is a broad-spectrum antibiotic developed specifically for use in veterinary medicine.
Its sister product, Nuflor (florfenicol) has been approved by FDA for use in beef and non-lactating dairy cattle since 1996.
Why the change?
FDA established VFD drugs to more closely control new therapeutic products — primarily antimicrobials — and their use in food animals. The new classification applies only to new therapeutics approved by the FDA after 1999 and administered in feed. All products approved before 1999 have maintained their over-the-counter (OTC) status.
Catfish producers will be able to obtain VFD drugs through normal feed distribution channels but they will require a signed Veterinary Feed Directive from a licensed veterinarian.
VFDs fall between OTC and prescription drugs, which are impractical for animal feeds.
"The VFD allows us to continue adding new drugs to our health tool box," stresses Richard Sellers, American Feed Industry Association.
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 will help reduce antibiotic resistance and prolong effectiveness of new antimicrobials through judicious use.
The first and thus far only drug to be classified and approved by the FDA since the approval of VFD status in 1996 was tilmicosin, an antimicrobial for swine respiratory disease.
"Most catfish feed mills have been through the federal medicated feed licensing process, so I'm confident they know what they're doing," points out Sellers, who will be speaking on VFD drugs at the Catfish Convention being held Feb. 24-26, 2005, in New Orleans.
Understanding the process
"While Aquaflor will be first new catfish drug in 19 years and only the second VFD drug of any kind in the US animal health market, the situation does not represent an insurmountable issue for the catfish producer or feed mill," says Dr. Patricia Gaunt, associate professor, aquatic animal health, Mississippi State University College of Veterinary Medicine.
"Most catfish feed mills are already licensed to manufacture these types of medicated feeds."
A feed mill already holding a Medicated Feed Mill License (MFML), a license to manufacture medicated feed, would simply need to file a notification letter with the FDA stating its intention to distribute an animal feed containing a VFD drug.
The starting point for obtaining feed with a VFD drug is with the producer experiencing sick fish. Producers can get a VFD from a diagnosing veterinarian or veterinary laboratory as long as there is what the FDA calls a "veterinarian-client-patient relationship" with the catfish producer. (See Box 1 Below.)
This VFD 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 prescribed only for the use specified on the product label.
"With the VFD form in hand, the producer can go to the feed mill to order and obtain the VFD-containing feed," points out Gaunt. (See Box 2 Below.)
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."
All VFD orders must be retained by the feed mill for a period of two years.
Short learning curve
"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 catfish 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," adds Gaunt.
Growers with questions on the VFD process should contact their diagnostic lab, extension service, veterinary college or veterinarian.
For information on the VFD process, contact Schering-Plough Animal Health. Phone: 1-800-224-5318. Email: palma.jordan@spcorp.com.
| Box 1: What is a VCP Relationship?
What exactly is the "veterinarian-client-patient relationship" needed to obtain an order for a new VFD drug?
FDA offers the following guidelines:
- The veterinarian has assumed responsibility for making clinical judgments regarding the health of the animals and the need for medical treatment, and the client has agreed to follow the veterinarian's instructions.
- The veterinarian has sufficient knowledge of the animals to initiate at least a general or preliminary diagnosis of the medical condition of the animals. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animals by virtue of an examination of the animals or by medically appropriate and timely visits to the premises where the animals are kept.
- The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regime.
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| Box 2: Follow the Path to VFDs Everyone involved in the production phase of the catfish industry must understand and follow the necessary steps needed in obtaining and feeding a Veterinary Feed Directive (VFD) drug.
Here's how the process works for catfish producers:
- Catfish producer contacts a veterinarian for diagnosis and treatment.
- Veterinarian works within the veterinarian-client-patient relationship to determine that a VFD drug is needed.
- Veterinarian issues a signed VFD form to the producer and/or feed mill.
- Catfish producer uses the VFD to order medicated feed from a feed supplier. The feed supplier must have a signed VFD on file in order to deliver feed.
- Licensed feed manufacturers or distributors that ship a VFD feed to another distributor or retailer must receive and retain a copy of a written acknowledgement stating that the VFD feed will further be distributed only in accordance with FDA requirements.
- The veterinarian issuing the VFD, the producer and the person or company supplying the VFD feed must retain copies of the signed VFD form for a minimum of two years.
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Aquaflor and Nuflor are registered trademarks of Schering-Plough Veterinary Corporation.
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