Dr. Harry Snelson - Antibiotics and Veterinary Feed Directive: The times, they are a changin'

Veterinary Feed DirectiveTimes, they are a changin’

Harry Snelson, DVMAmerican Association of Swine Veterinarians

Antibiotic RegulationUS Food and Drug Administration

regulates animal and human antibiotics◦OTC◦RX◦VFD

State pharmacy boards have authority over veterinary prescribing

Veterinary Feed DirectiveImplemented in 1996Provides for veterinary oversight

without requiring a prescription3 swine products

◦Nuflor◦Pulmotil◦Avilamycin

Antibiotic Label ClaimsDisease TreatmentDisease ControlDisease 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

Antibiotic ClassesMedically 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

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 implementation

Veterinary Feed DirectiveCurrent 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

FDA medically importantAll 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

Veterinary Feed DirectiveVFD final rule will go into effect in

October, 2015Growth 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

Guidance for IndustryWhat 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

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

How will this affect pork producers?Producers are going to lose some

antibiotics, or uses of antibioticsPotentially increased costs and

increased timeProducers will need a close

relationship with their veterinarian

Veterinary Responsibilities

Veterinary ResponsibilitiesMust be licensed;operating in the course of

practice and in compliance;must write VFD orders in the

context of a VCPR;

VFD proposed final ruleVCPR – 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.

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;

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.

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

One final point….

Extra-label use of feed grade antimicrobials remains ILLEGAL for both veterinarians and producers

Questions?