Veterinary Feed Directive Drugs...
Intervet Schering-Plough Animal Health Corporation prepared a training package for the catfish industry to help in their understanding of FDA's new category of animal drugs referred to as Veterinary Feed Directive (VFD) drugs . The AADAP Program has gained permission to make these same materials available on our website.
The U.S. Fish & Wildlife Service AADAP Program would like to acknowledge intervet Schering-Plough Animal Health Corporation for granting that permission. Additionally, we would like to acknowledge David A. Bossman and Richard Sellers of the American Feed Industry Association; Rosalie Schnick, National Coordinator for Aquaculture New Animal Drug Applications; the Editors of Feedstuffs and Feed Additive Compendium, Miller Publishing Company; and the Veterinary Feed Directive Coalition, for their assistance in compiling this information.
The two original FDA animal drug categories, over-the-counter (OTC) and prescription, did not provide the necessary flexibility and safety for new drugs (especially antimicrobials) to be prescribed and administered via animal feeds. Hence, input was provided to FDA, through an industry and government coalition, resulting in the Federal Animal Drug Availability Act (ADAA) of 1996 and its resulting regulations that created the VFD category. VFD drugs, which require veterinary supervision, will allow for the ready availability of medicated feeds through normal animal feed production channels, while still improving animal health and human food safety. The Intervet Schering-Plough training package includes: actual regulations, definitions, instructions, forms, samples of required letters to be sent to FDA, and other helpful information to improve the understanding of VFD drugs.
The Intervet Schering-Plough training package include three items and can be accessed through the following links:
- Their training document entitled: "Veterinary
Feed Directive (VFD) Drugs: Impact on Feed Mills Serving
the Catfish Industry"
- FDA Form 2656 entitled: "Registration
of Drug Establishment/Labeler Code Assignment
- FDA Form 3448 entitled: "Medicated Feed Mill License Application"
Other information pertaining to VFD drugs...
A variety of other documents have recently become available that provide detailed information on VFD drugs, their recommended uses and documented observations of their use. These documents only pertain to AQUAFLOR® and have been published by the drug manufacturer, Intervet Schering-Plough Animal Health (ISPAH). ISPAH is currently the only pharmaceutical firm with an approved VFD drug for aquatic species. The following documents are presented as a PDF file and/or an HTML file.
Our reference to the following ISPAH documents in no way constitutes U.S. Fish & Wildlife Service endorsement of the ISPAH products or their use.
ISPAH-produced VFD information as it pertains to AQUAFLOR®
VFD Drugs: Impact on Feed Mills Serving the Aquaculture Industry (PDF)
AquaFAQs 2: VFD Drugs and You: Understanding Your Role (PDF or HTML)
VFD Form – AQUAFLOR® (PDF)
VFD Form – AQUAFLOR®-CA1 (PDF)
Establishing feed distributorship eases VFD process for fish farmers (PDF and HTML)
ISPAH News Releases regarding Aquaflor®
AQUAFLOR® Approved for Controlling Mortality Due to Furunculosis in Freshwater-Reared Salmonids (HTML)
AQUAFLOR®-CA1 Conditionally Approved By FDA for Controlling Columnaris in Catfish (HTML)
AQUAFLOR® Approved for Freshwater-reared Salmonids (HTML)
FDA Approves AQUAFLOR® for Channel Catfish (HTML)
Intervet Schering-Plough Animal Health Names Kasha M. Cox Territory Manager, U.S. Aquaculture (HTML)
General information brochures produced by ISPAH
Freshwater-reared Salmonids (HTML or PDF)
ISPAH-produced technical service bulletins
AquaBulletin 1: Enteric septicemia of catfish (HTML or PDF)
AquaBulletin 2: Experience with AQUAFLOR® in North Carolina Trout (HTML or PDF)
Independently-written/SPAH-published articles related to AQUAFLOR®
Terrill R. Hanson. 2006. The economic implications of feeding fingerlings during outbreaks of enteric septicemia in catfish. SPAH-AQF-43. (HTML or PDF)
Lora Petrie-Hanson. 2007. Catfish immunity and the effect of antibacterial treatment. SPAH-AQF-56. (HTML or PDF)
Craig Shoemaker, Phil Klesius and Chhorn Lim. 2007. Feed deprivation increases the susceptibility of channel catfish to columnaris disease. SPAH-AQF-65. (HTML or PDF)