OVERVIEW OF THE 2017 VFD PROGRAM

Transcription

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

2 BACKGROUND 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, VFD Final Rule became effective October 1, VFD Medications transitioning from over the counter (OTC) to VFD status becomes effective January 1, 2017.

3 SO ARE VFD DRUGS CONSIDERED PRESCRIPTION DRUGS? 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!

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8 Water Soluble Drugs Transitioning From OTC to Rx Status Continued

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11 Iowa administrative rules chapter (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 (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.

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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 Manuals/CompliancePolicyGuidanceMa nual/ucm htm

35 QUESTIONS AND ANSWERS

36 References/Resources For more information: Guidance for Industry #120, #209, #213, # CFR (VFD) 21 CFR 225 (cgmp) Website: Current Blue Bird Labelling lfoodfeeds/medicatedfeed/default.htm#license