USING VETERINARY FEED DIRECTIVE DRUGS IN AQUACULTURE

A veterinary feed directive (VFD) is a written statement issued by a licensed veterinarian that authorizes the use of a VFD drug in animal feed.   In 2000, the US FDA issued the 1^st VFD Rule and finalized regulations for distribution and use of VFD drugs. In 2005 Aquaflor® became the first VFD drug used in aquaculture. Unlike previous antibiotics, orders for VFD drugs were available to fish producers (clients) only through licensed veterinarians.

Use of antibiotics in food animals has been debated for decades, and in response to continued concern over antimicrobial resistance in humans, FDA has issued several guidelines.  In 2012 FDA finalized the "Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" (Guidance #209) which represented FDA's thinking on antimicrobial drugs that are medically important in human medicine and also used in food-producing animals. The two main principles covered by this guidance were to (1) limit medically important antimicrobial drugs to uses in animals that were necessary for assuring animal health, and (2) include veterinary oversight on medically important antimicrobial drugs used in animals. This guidance would gradually eliminate the use of medically important antimicrobial drugs for production purposes and phase in veterinary oversight of therapeutic uses of these drugs.   

Another FDA guideline was Guidance #213 "Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209" finalized in 2013  to provide pharmaceutical sponsors with  recommendations to voluntarily modify the use of their medically important antimicrobial drug products to support the two principles in Guidance #209.   This guideline changed the marketing status of antibiotics from over the counter to either a prescription (if dispensed in water) or VFD (if dispensed in feed) effective January 2017 and to withdraw production uses.  This marketing shift requiring veterinary oversight was an important step to decrease microbial food safety risks of antimicrobial animal drugs.

The FDA also revised the 1^st VFD rule of 2000 based on Guidances #209 and #213, and in 2015 published the 2^nd (Final) VFD rule (USFDA CVM 2015). This detailed what information must be included on the VFD order.   The Final Rule went into effect October 1, 2015 for Aquaflor® because it was already a VFD drug.  The target date for conversion of Romet® and Terramycin® from over-the-counter drugs to VFD drugs is January 1, 2017.

The major provisions of the Final VFD rule cover  revised definitions, information required on a VFD order, changes to veterinary client patient relationship (VCPR) requirements, VFD expiration dates and duration of use, VFD refills, number of animals to be treated, affirmation of intent statements, extra-label use of VFD drugs, transmitting VFD orders and recordkeeping. All of these topics will be discussed in detail in the presentation.