Discussion on the Veterinary Feed Directive Integration in Aquaculture - Dr. Patricia S. Gaunt, Mississippi State University, from the 2017 NIAA Annual Conference, U.S. Animal Agriculture's Future Role In World Food Production - Obstacles & Opportunities, April 4 - 6, Columbus, OH, USA. More presentations at http://www.trufflemedia.com/agmedia/conference/2017_niaa_us_animal_ag_future_role_world_food_production

1. Using Veterinary Feed Directive Drugs in
Aquaculture
Patricia S. Gaunt, DVM, PhD, DABVT
Mississippi State University
College of Veterinary Medicine

2. Antimicrobial Medicated Feeds
Approved for US Aquaculture
 Terramycin ® (Oxytetracycline)
 Romet ® (Ormetoprim sulfadimethoxine)
 Aquaflor® (Florfenicol)

3. Aquaflor® Approved as VFD Drug
 Approved by FDA October 2005 under
1st VFD Rule
 First aquatic VFD drug
 Initially for catfish to treat enteric septicemia of
catfish (ESC) only
 Label claim expanded to include many other
bacteria and fish species

4. VFD Feed: Veterinarian’s Responsibilities
Licensed and maintain valid Veterinarian-
Client-Patient Relationship (VCPR)
1. Knowledge of fish health by recent
examination of fish and/or visit to farm
2. Responsibility for clinical judgement
of fish health
3. Availability for follow-up care
4. Oversight for proper use of medication
• Prompt treatment
• Proper regime
5. Maintenance of medical records

5. Veterinarian’s Responsibilities (cont’d)
 Issue VFD order in writing with ALL
required information to client
 Maintain electronic or original
order and available for FDA
inspection for 2 years
Some states require medical records
retention for >2 years
 Provide electronic or hardcopy to
producer and distributor

6. VFD feed: Producer’s (Client’s)
Responsibilities
 Cooperate with veterinarian
to maintain valid VCPR
 Follow dose rate, duration,
expiration date, and withdrawal
time
 Maintain electronic or hard
copy of VFD orders for FDA
inspection for 2 years
 If in agreement with
veterinarian, present copy
of VFD order to distributor

7. Highlights of New (Second) VFD Rule
 New (Second) VFD Rule in effect
 Aquaflor ® (10/01/2015); Terramycin® and Romet ® (01/01/2017)
 VFD expiration date can be extended up to 6 months by veterinarian
 Order forms require production class and approximate number of fish rather
than biomass
 Producer and distributor calculate feed quantity
 Extra-label use of VFD drugs not approved
 FDA using enforcement discretion for ELDU

8. What’s New in the New VFD Rule?
(21 CFR 558.6(b))
 Expiration date:
 2nd (New) VFD Rule: VFD order expires when veterinarian deems: ≤ 6 months from date of
issuance
• In effect for Aquaflor® 10/1/2015
• In effect for Romet® and Terramycin® 1/1/2017
 Duration of use (not new):
 Part of label claim: Part of approval, conditional approval or index listing
 e.g. 1x/day for 10 days
 If VFD order expires prior to completing duration of use, veterinarian must issue a new VFD
order
 Refills
 No refills allowed with VFD aquaculture drugs

9. Example: VFD Orders and Expiration Date
 May 1: Pond 1 is stocked with catfish fingerlings and breaks with enteric
septicemia of catfish (ESC)
 Ponds 2, 3, 4, and 5 are adjacent fingerling catfish ponds
 Producer needs VFD drug with 10 day duration of use to treat ESC in
Pond 1. He expects fish in ponds 2, 3, 4, and 5 to break with ESC also
and requests a VFD order with a 10 week expiration date to cover fish in
ponds 1-5
 No refills: If pond 1 breaks with ESC again (after May 1-10, a new VFD
order must be issued for it)
1 2 3 4 5
May 1-10 May 20 -29 May 21- 30 June 11- 20 June 25 -July 4

10. Extra-label Use of Medicated Feeds
 The statement: “Extra-label drug use (ELDU) of VFD drugs is
strictly prohibited” is required on the VFD drug order
 Few drugs available for aquaculture, FDA CVM will use
enforcement discretion for extra-label use under New VFD Rule
(CPG 615.115)
 Must have a valid VCPR, follow duration of use, withdrawal times,
proper regime, maintenance of records

12. VFD ELDU: Additional Information on VFD Forms
Required Under “Special instructions”
 VFD issued in accordance with
CPG 615.115
 Species/indication for which being issued (
different)
 Withdrawal time (if different)
Contained, Traceable fish
Same rules on VFD orders apply as with
approved VFD label claims

13. Thanks for Your Attention!