Changes recommended to FDA’s draft VFD guidance

Recommendations include clarification on electronic storage, expiration date on medicated feed, and use of units beyond gram/-per-ton for feed.

May 31, 2019

3 Min Read
A grain co-op feed mill facility in Indiana, USA.

The National Grain and Feed Assn. (NGFA) and American Feed Industry Assn. (AFIA) made several recommendations to the U.S. Food and Drug Administration (FDA) regarding its draft Veterinary Feed Directive (VFD) guidance. 

FDA made the draft guidance available on March 27 to provide the agency’s current thinking on responsibilities associated with all parties involved with VFD orders – veterinarians, VFD feed distributors (e.g., feed mills) and clients (i.e., owners or other caretakers of food-producing animals). The document expanded upon a previous FDA VFD guidance issued in September 2015 by adding 53 new questions and answers and revising 14 others. The new and revised questions and answers address a wide range of issues that have emerged as a result of the increased use of the VFD process. 

The VFD regulations establish requirements for authorizing the use of animal drugs in or on feed that require the supervision of a licensed veterinarian. FDA’s updated VFD rule went into effect Oct. 1, 2015, and the agency’s implementation of policies to promote the judicious use of antimicrobial drugs in food-producing animals was completed Jan. 1, 2017. Based upon FDA’s policies, all production uses (e.g., growth promotion) of medically important antimicrobials approved for use in the feed or drinking water of food-producing animals were eliminated, and such drugs now only can be used for therapeutic purposes under veterinary oversight.

In its statement, NGFA commended FDA for updating the guidance with valuable information for all parties covered by the VFD regulations. However, NGFA also made recommendations for several questions and answers in the draft guidance where it believes further consideration by FDA is warranted before final guidance is issued. Among NGFA’s recommendations were that FDA:   

Related:FDA issues revised Q&A draft guidance on VFD regulation

  • In situations where a grams-per-ton level is not provided by approval, conditional approval, or index listing for the VFD drug, allow the veterinarian to state dosage (e.g., milligram-per-head-per-day) on the VFD order instead of the grams-per-ton level of the drug in the medicated feed so that the client has flexibility to choose the most appropriate treatment product.

  • Further clarify that distributors and clients need not store electronic VFDs using computer systems that are compliant with FDA’s onerous 21 CFR part 11 requirements associated with electronic records and electronic signatures.

  • Revise FDA’s current interpretation so as to recognize the VFD distributor to be the party that the client first approaches to fill the VFD order, regardless of whether such party takes physical possession of the VFD feed. 

  • Eliminate FDA’s suggestion that the expiration date for medicated feed, when not indicated on the label, generally is three months from the date of manufacture.  Instead, the NGFA recommended that the feed manufacturer be contacted about the shelf life of the product.

  • While evaluating distributor compliance, not place an undue inspectional emphasis on attempting to evaluate whether a “reasonable” quantity of VFD feed was distributed, since the VFD regulations do not require distributors to forecast and maintain records on how much feed is anticipated to be associated with each VFD order. 

Paul Davis, AFIA director of quality, animal food safety and education, said aside from expressing gratitude for the agency’s work to clarify several questions from industry, AFIA also urged the agency to modify a few key questions, including not be overly prescriptive with drug levels in feed, since there are more than 30 indications that can be expressed accurately and appropriately in units of measure beyond “g/ton” and to clarify that only one “distributor” be permitted per VFD transaction, particularly since many feed mills that manufacture VFD products work with bulk delivery vehicles and deliver products for dealers, which act as VFD distributors transactionally.


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