Veterinary Feed Directives Are Here: What Have You Done? - Jeff Verzal, Iowa Department Of Agriculture And Land Stewardship (IDALS), from the 2017 Iowa Pork Congress, January 25-26, Des Moines, IA, USA. More presentations at http://www.swinecast.com/2017-iowa-pork-congress

1. Iowa
Department of
Agriculture and
Land
Stewardship
Jeff Verzal,
Compliance
Investigator
OVERVIEW OF THE 2017
VFD PROGRAM

2.  In 1996 Congress passed Federal Law stating that medicated
feeds which require veterinarian oversight are VFDs.
 In 2000 FDA finalized regulations for authorization,
distribution and use of VFDs.
 Updates to the VFD Regulation: Changes intended to make
process more efficient while continuing to provide public
health protections.
 VFD Final Rule was published June 3, 2015.
 VFD Final Rule became effective October 1, 2015.
 VFD Medications transitioning from over the counter (OTC) to
VFD status becomes effective January 1, 2017.
BACKGROUND

3.  Although similar in concept, (…by or on the order of a licensed
veterinarian) VFD drugs are NOT Rx drugs.
 Feed additive medications Can Not Be Used In An Extra-Label
Use Manner!
SO ARE VFD DRUGS CONSIDERED
PRESCRIPTION DRUGS?

8. Water Soluble Drugs Transitioning From
OTC to Rx Status Continued

11. Iowa administrative rules chapter 811—12.1(169)
Veterinarian/client/patient relationships.
12.1(1) The board shall determine, on a case-by-case basis, if a valid
veterinarian/client/patient relationship exists. This relationship shall be
deemed to exist when all of the following criteria have been met:
a. The licensed veterinarian has assumed the responsibility for making
medical judgments regarding the health of the patient and the need for
medical treatment, and the client has agreed to follow the instructions
of the licensed veterinarian;
b. The licensed veterinarian has sufficient knowledge of the patient to
initiate at least a general or preliminary diagnosis of the medical
condition of the patient. Sufficient knowledge means that the licensed
veterinarian has recently seen or is personally acquainted with the care
of the patient by virtue of an examination of the patient or by medically
appropriate and timely visits to the premises where the patient is kept;
and
c. The licensed veterinarian is readily available or provides for follow-up
in case of adverse reactions or failure of the regimen of therapy.

12. Iowa administrative rules chapter 811—
12.1(169) Veterinarian/client/patient
relationships.
12.1(2) A valid veterinarian/client/patient
relationship cannot be established by contact solely
based on a telephonic or electronic communication.
This chapter became effective July 2, 2014.

26. Client’s Responsibilities
• Only feed bearing or containing a VFD drug or combination
VFD drug (a VFD feed or combination VFD feed) to animals
based on a VFD issued by a licensed veterinarian;
• Not feed a VFD feed or combination VFD feed to animals after
the expiration date on the VFD;
• Provide a copy of the VFD order to the feed distributor if the
issuing veterinarian sends the distributor’s copy of the VFD
through you, the client;
• Maintain a copy of the VFD order for a minimum of 2 years;
and
• Provide VFD orders for inspection and copying by FDA upon
request.
• Extra-label use of VFD Feed (or any other medicated feed) is
not permitted.

27. Veterinarians’ Responsibilities
• Must be licensed to practice veterinary medicine;
• Must be operating in the course of the veterinarians'
professional practice and in compliance with all
applicable veterinary licensing and practice
requirements;
• Must write VFD orders in the context of a valid
client-patient relationship (VCPR);
• Must issue a VFD that is in compliance with the
conditions for use approved, conditionally approved
or indexed for the VFD drug or combination VFD
drug;

28. Veterinarians’ Responsibilities
• Must prepare and sign written VFD providing all
required information;
• May enter additional discretionary information to
more specifically identify the animals to be
treated/fed the VFD feed;
• Must include required information when a VFD
drug is authorized for use in combination that
includes more than one VFD drug;
• Must restrict or allow the use of the VFD drug in
combination with one or more OTC (over the
counter) drug(s);

29. Veterinarians’ Responsibilities
• Must provide the feed distributor with a copy of
the VFD;
• Must provide the client with a copy of the VFD
order;
• Must retain the original VFD for 2 years, and
• Must provide VFD orders for inspection and
copying by FDA upon request.

30. Distributors’ Responsibilities
• File a one-time notice with FDA of intent to
distribute VFD drugs;
• Notify FDA within 30 days of any change in
ownership, business name, or business address;
• Fill a VFD order only if the VFD contains all
required information;
• Ensure that the distributed animal feed containing
the VFD drug or combination VFD drug complies
with the terms of the VFD and is manufactured and
labelled in conformity with the approved,
conditionally approved, or indexed conditions of use
for such drug;

31. Distributors’ Responsibilities
• Ensure all labelling and advertising prominently and
conspicuously displays the following cautionary
statement: “Caution: Federal law restricts
medicated feed containing this veterinary feed
directive (VFD) drug to use by or on the order of
a licensed veterinarian.”;
• Retain VFD orders for two years from the date of
issuance;
• Retain records of the receipt and distribution of all
medicated animal feed containing a VFD drug for 2
years;
• Provide VFD orders for inspection and copying by FDA
upon request;

32. Distributors’ Responsibilities
• Retain records of VFD manufacturing for 1 year in
accordance with 21 CFR Part 225 and make such records
available for inspection and copying by FDA upon
request;
• Obtain, as the originating distributor (consignor), an
acknowledgement letter from the receiving distributor
(consignee) before the feed is shipped; and
• Retain a copy of each consignee distributor’s
acknowledgement letter for two years.
• If you issue VFD feed only to a client (the end user)
under a valid VFD order, you will not need to have
an acknowledgement letter.

33. Compliance

34. Current Issues Since Transition as of
January 01, 2017
• VFD’s written in a legal and valid format.
• Species, Production Class, Indications for Use
• Special Instructions
• Documentation
• Communication
• Minor Species: Compliance Policy Guide 615.115
http://www.fda.gov/ICECI/Compliance
Manuals/CompliancePolicyGuidanceMa
nual/ucm074659.htm

35. QUESTIONS AND ANSWERS

36. References/Resources
• https://www.federalregister.gov
• For more information:
• AskCVM@fda.hhs.gov
• Guidance for Industry #120, #209, #213, #233
• 21 CFR 558.6 (VFD)
• 21 CFR 225 (cGMP)
• Website: http://www.fda.gov/safefeed
• Current Blue Bird Labelling
http://www.fda.gov/AnimalVeterinary/Products/Anima
lFoodFeeds/MedicatedFeed/default.htm#license