Antibiotics and Veterinary Feed Directive: The times, they are a changin' - Dr. Harry Snelson, American Association of Swine Veterinarians, from 2015 Summer Swine Health Seminar, August 22, 2015, Wrightsville Beach, North Carolina, USA. More presentations at http://www.swinecast.com/2015-boehringer-ingelheim-carolina-swine-health-seminar

1. Veterinary Feed Directive
Times, they are a changin’
Harry Snelson, DVM
American Association of Swine Veterinarians

2. Antibiotic Regulation
 US Food and Drug Administration
regulates animal and human
antibiotics
◦ OTC
◦ RX
◦ VFD
 State pharmacy boards have authority
over veterinary prescribing

3. Veterinary Feed Directive
 Implemented in 1996
 Provides for veterinary oversight
without requiring a prescription
 3 swine products
◦ Nuflor
◦ Pulmotil
◦ Avilamycin

4. Antibiotic Label Claims
 Disease Treatment
 Disease Control
 Disease Prevention
◦ Treatment, Control and Prevention are
considered therapeutic
◦ FDA has said they are necessary for
animal health and welfare
 Growth Promotion or Improvement of
Nutritional Efficiency

5. Antibiotic Classes
 Medically important (as defined by
FDA)
◦ Same, or in same classes, as antibiotics
used to treat humans
◦ Most antibiotics approved for use in
animal feed are medically important with
possible exceptions:
 Swine: bacitracin, mecadox, narasin,
bambermycin, and tiamulin

6. Guidance for Industry #209
 “Production uses” (growth promotion and
nutritional efficiency) of antibiotics in
classes used in human medicine are
injudicious
◦ Does not call them unsafe
 Requires other uses of these same
classes of antibiotics be under
“veterinary oversight”
 “Voluntarily” working with sponsors to
discontinue claims or migrate production
claims to disease prevention
◦ Guidance #213 gives roadmap on

7. Veterinary Feed Directive
 Current requirements
◦ Written for amount of feed to be
consumed in a time period
◦ Original copy required to the feed mill
within 5 days
◦ VCPR
◦ Refills not straightforward
◦ Keep records (mill, veterinarian, farmer)
for two years

8. FDA medically important
 All swine antibiotics will be affected
under Guidance 209 except
◦ Bacitracin
◦ Carbadox
◦ Bambermycin
◦ Ionophores
◦ Tiamulin
These antibiotics will remain
available for growth promotion
and/or over-the-counter (OTC) in
feed and water

9. Veterinary Feed Directive
 VFD final rule will go into effect in
October, 2015
 Growth Promotion and Nutritional
Efficiency Labels will be removed by
Dec. 2016
◦ “Medically Important”
 Disease Prevention, Control and
Treatment will be VFD in feed, Rx in
water

10. Guidance for Industry
 What does it really mean?
◦ Most growth promotion uses will end by
December 2016
◦ Most feed grade antibiotics will no longer
be available over-the-counter but will
require a veterinary “order”
◦ Antibiotics in water will require a
prescription

11. What does this really mean?
 Significant regulatory step that will
result in changes on how antibiotics
are used on the farm
 Once those labels are changed, it will
be illegal to utilize these antibiotics to
promote growth
 Producers will need a VFD or
prescription to use these products in
feed and water

12. How will this affect pork
producers?
 Producers are going to lose some
antibiotics, or uses of antibiotics
 Potentially increased costs and
increased time
 Producers will need a close
relationship with their veterinarian

13. Veterinary Responsibilities

14. Veterinary Responsibilities
 Must be licensed;
 operating in the course of practice and
in compliance;
 must write VFD orders in the context
of a VCPR;

15. VFD proposed final rule
 VCPR – minimum requirements:
◦ the veterinarian engage with the client to
assume responsibility for making clinical
judgments about patient health,
◦ have sufficient knowledge of the patient
by virtue of patient examination and/or
visits to the facility where the patient is
managed, and
◦ provide for any necessary follow-up
evaluation or care.

16. Veterinary Responsibilities
(con’t)
 must only issue a VFD that is in
compliance with approved use;
 must prepare a written (nonverbal)
VFD including the veterinarian’s
signature;
 VFD includes all required information;

17. Information Required on VFD
• The veterinarian’s name, address,
and telephone number;
• the client’s name, business or home
address, and telephone number;
• the premises at which the animals
specified in the VFD are located;
• the date of VFD issuance;
• the expiration date of the VFD;
• the name of the VFD drug(s);
• the species and production class of
animals to be fed the VFD feed;
• the approximate number of animals
to be fed the VFD feed by the
expiration date of the VFD;
• the indication for which the VFD is
issued;
• the level of VFD drug in the feed
and duration of use;
• the withdrawal time, special
instructions, and cautionary
statements necessary for use of the
drug in conformance with the
approval;
• the number of reorders (refills)
authorized, if permitted by the drug
approval, conditional approval, or
index listing;
• the statement: “Use of feed
containing this veterinary feed
directive (VFD) drug in a manner
other than as directed on the labeling
(extralabel use), is not permitted”;
• an affirmation of intent for
combination VFD drugs as described
in 21 CFR 558.6(b)(6); and
• the veterinarian’s electronic or
written signature.

18. Veterinary Responsibilities
(con’t)
 must include certain drug-specific information for each
VFD drug when authorizing drug combinations that
includes more than one VFD drug;
 VFD + OTC drugs, must include on the VFD order an
affirmation of intent either to restrict authorized use only
to the VFD drug cited on the VFD or to allow the use of
the cited VFD drug in an approved combination with
one or more OTC drug(s);
 must provide the distributor and client with a copy of the
VFD order;
 all must retain the original VFD for 2 years; and
 must provide VFD orders for inspection and copying by
FDA upon request

19. One final point….
Extra-label use of feed grade
antimicrobials remains ILLEGAL for both
veterinarians and producers

20. Questions?