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Veterinary Feed Directive (VFD) and

Increasing Antibiotic RegulationRichard Sellers, PAS, Dipl., ACAN

American Feed Industry Association

Swine Summit: Up to the Challenge

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Who is AFIA?

• Founded in 1909 as the American Feed Manufacturers Association to promote feed safety and state feed uniformity

• 20 staff members in Arlington, VA, with 10 of us that lobby

• 625 corporate members that include equipment, feed, pet food and integrators and many ingredient manufacturers and distributors

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VFD: The Origins

• The Veterinary Feed Directive arose in 1995 to prevent FDA from making new, approved animal drugs as Rx/prescription medicated feed

• Such Rx feeds would have required DVMs or pharmacists to dispense feed from mills

• The VFD was created in the Animal Drug Availability Act in 1996 and says VFD is not a Rx in federal or state law

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VFD: The Origins• The first drug, tilimicosin (Pulmotil®), was

approved 70 days later, now nearly 200 animal drugs are VFD

• In 2013, FDA decided that antibiotics critical for use in human medicine and used in animal feed should no longer be fed for production uses, such as growth promotion or feed efficiency

• FDA old drug sponsors they have three years to change and submit new labels (Dec. 2016)

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VFD: The Origins• Some 70 drug uses went away, including

penicillin

• This new policy included previously OTC water medications, which went to Rx

• OTC injectables are not currently on the FDA radar

• Most were changed at the end of 2016 and some changed in February for market reasons

• We now have the complete VFD drug list

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Animal Drugs Expected to be VFD Drugs

Aivlocin (new VFD)Avilamycin (new VFD)ChlortetracyclineErythromycin (not marketed)Florfenicol (already VFD)Hygromycin BLincomycinNeomycin

OxytetracyclinePenicillin (in combination only)StreptomycinSulfadimethoxine:OrmetoprimTilmicosin (already VFD)TylosinSulfamethazineVirginiamycin

https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm482107.htm

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VFD: What is it?• VFD is both the form and the drug

• It authorizes the producer to use a VFD-containing medicated feed in the manner listed on the VFD form

• It is specific for a group of animals at a specific location

• It must be reauthorized when the feed runs out

• One copy kept by veterinarian (original), producer and feed distributor for two years

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VFD: Legal Issues• It is a criminal felony to knowingly feed a VFD

medicated feed without a legal VFD

• Producers may not “loan” VFD-containing feed to other producers

• VFD-containing feed must be fed at the level on the VFD and to the animals on the VFD

• If the time limit on the VFD expires during the feeding time, another VFD must be obtained before feeding can restart

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VFD: The ProcessVeterinarian

(retains original)

Producer (does not send any letters)

Feed Distributor

FDA Drug Supplier

Sends “intent to distribute letter”

Sends “acknowledgement letter”

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VFD: Required Form Information• Drug/trade name • Level of drug• Indications for use • Location of animals• Number and kind of animals • Name/address/phone of veterinarian• Treatment date (length of treatment/expiration)• VFD date • Feeding instructions • Withdrawal time, if any• Warning and/or cautionary statements • Veterinarian’s signature • VFD statement• Veterinarian’s intention statement• Extra-label drug use prohibition

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FDA Resources• FDA has number of resources on VFD including

the list of both drug and market names of drugs changed to VFD

• There are several brochures, videos and Q&A documents for producers, veterinarians and feed distributors

• Check out this link to learn more:https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

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VFD: The Changes• These drugs are now the control of a

veterinarian via VFD

• This includes many feed drugs except dewormers, carbadox, bambermycins, ionophores, bacitracin and a few others that did not change

• AFIA has focused on the VFD process and the administrative changes needed to assist in an orderly transition

• VFDs will be required for each use of a drug, including for FFA and 4-H use

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VFD: Practical Issues• Original VFD form is retained by the veterinarian

and copies to the producer and feed distributor• Faxes (and limited electronic of e-VFDs) VFDs are

allowed• Phone-in VFDs are not allowed• Feed mills can deliver smaller amounts than on VFD

and save rest for later• Delivering a VFD to the farm before the producer

has a VFD form is problematic—as VFD medicated feed cannot be stocked without a VFD by a producer, unless s/he is a feed distributor

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VFD: Current Challenges (cont’d.)

• More VFD approvals increases paperwork load and review times for feed mills;

• Electronic VFDs will become commonplace within six months

• AFIA says say feed mills put at disadvantage when producer customer cannot be served appropriately due to incorrect forms

• We hope to see required paper records be replaced with electronic ones soon

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VFD: Other Issues

• The following concerns have arisen:

– Veterinarians must complete a “Veterinarian’s Intention Statement”

– FDA will allow faxes and pdfs without hard copies

– Producers must maintain VFD copies for two year but can do so electronically or for integrated operations, the feed mill will hold the VFDs.

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VFD: Affirmation Statements

Veterinarian must mark one of the following on each VFD form:

1. ``This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.''

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VFD: Affirmation StatementsVeterinarian must mark one of the following on each VFD form:

2. ``This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.'' [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.]

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VFD: Affirmation StatementsVeterinarian must mark one of the following on each VFD form:

3. ``This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.'' (Sec. 558.6(b)(6)).

AFIA recommends vets mark #3

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VFD: Generic Drug UseGenerics may be used if the drug or tradename is listed and the veterinarian doesn’t object on the VFD form.

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What should feed distributors know

• You can distribute VFD feed to another distributor or to the client-recipient of a VFD.

• You must get a written (nonverbal) acknowledgement letter from the receiving distributor before distributing the VFD feed.

• You must get a copy of a VFD containing all the information required by regulation before distributing a VFD feed to the client-recipient.

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What feed distributors should know• Under VFD regulation, a "distributor" means any

person who distributes a medicated feed containing a VFD drug to another person.

• Distributors are required to notify FDA prior to the first time you distribute animal feed containing a VFD drug.

• You must provide a letter of acknowledgment to the distributor/feed mills before distributing VFD feed.

• This letter says you will not distribute the VFD-containing product without a similar letter or VFD

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VFD: Producer Preparation

• Meet with your veterinarian now to see how s/he will be handling VFDs for you

• Vets must comply with veterinarian/patient/client/relationship requirements in state/federal rules

• These drugs will not be used in every load—only for therapeutic use, including prevention.

• The most important thing is to have a relationship with a veterinarian regularly

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VFD: What’s Next

• This rule will not likely “roll back”

• President’s Council on Antibiotic Resistance is continuing at least until September

• There may be some more approval tweaks by FDA

• Things will/are calming down as folks/vets become familiar with VFD and these drugs

• Still some major issues, mostly in cattle: blocks, liquid feed, free-choice

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VFD: What’s Next

• California has a bill very similar to FDA to go into effect in 2018

• Maryland will require some reporting by vets

• Minnesota, usually a hotbed of antibiotic bills had none this year

• Oregon has tried some as well, but no this year

• Keep Calm and write legal VFDs

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Questions/Discussion

THANK YOU