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Beef producers to see changes with rollout of antibiotic VFDs

veterinary drug regulations
New rules governing what you can use to treat cattle are phasing in with final changes to be implemented by December 2016. Here's a primer on the basics.

Veterinarians from across the country spent a full day at Texas A&M University, in conjunction with the 61st Annual Beef Cattle Short Course, discussing judicious use of antibiotics in animal agriculture and effects on beef production from increased government regulations on use of medically important antibiotics (antimicrobials). These regulations will affect all facets of beef production including stocker programs.

“The current Veterinary Feed Directive was established in 1996 by the United States Food and Drug Administration for antibiotic use through the Animal Drug Availability Act,” said Tom Hairgrove, DVM, Texas A&M AgriLife Extension Service. “This action created a new regulatory category for certain animal drugs with the intent of increasing veterinarian oversight over medically important antibiotics. The VFD stipulates that new animal drugs for use in or on feed are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian’s professional practice.”

Hairgrove adds that additional regulations concerning VFDs were adopted by FDA in 2015 which simplified the required paperwork and accepted electronic records and forms.

“On December 13, 2013, the FDA requested manufacturers of medically important antibiotics to voluntarily withdraw claims, within 90 days, for feed efficiency and weight gain," Hairgrove says. "Within three years, all medically important antibiotics listed as over the counter (OTC) drugs would be included in the VFD, with all changes implemented by December, 2016.”

“The antibiotic issue arose from concerns over development of antibiotic resistant bacteria in food animals that can become a human health problem,” said Virginia Fajt, DVM, PhD Pharmacologist at Texas A&M University’s College of Veterinary Medicine. “Antibiotic residues in food are not necessarily the concern."

FDA requires residue testing in meat and milk before a pharmaceutical can be registered for sale and use. Toxicological tests are also required to measure its effects on humans. Withdrawal periods of treated animals from market are assigned to each product when necessary to allow for residues in meat and milk sufficient time to degrade below possible harmful levels. Length of the withdrawal periods includes wide margins to ensure food safety.

Resistance concerns

“FDA addressed antimicrobial resistance with two over-arching policies which are assurance that antimicrobials in feed will not be used for growth promotion or feed efficiency and that antimicrobials will be used only for treatment, control or prevention of disease,” said Hairgrove. “Use of antimicrobials in feed will require a veterinarian to prepare a VFD and a veterinary-client-patient relationship must be in place before the VFD can be issued. It is important to note that extra-label use of antibiotics in feed is prohibited and it is illegal for a veterinarian, feed mill or producer to alter the label dose.”

The VFD is the primary mechanism for veterinary oversight or supervision of medically important antimicrobials administered in feed. “VFDs are like prescriptions, but are only used for feed. They are federally regulated, whereas prescriptions are regulated by the states. Currently there are two approved VFD drugs – tilmicosin and florfenicol; but all medically important over-the-counter drugs will become regulated in 2016. Most veterinarians, involved in beef cattle practice, have never issued a VFD,” Hairgrove adds.

There are 3 categories of veterinary drugs regulated by FDA – Over-the-counter, Prescription and VFD, Fajt says. FDA-approved uses of antibiotics include:

* Therapeutic treatment for animals that are sick;

* Disease control for a group of animals when some of the animals are sick;

* Disease prevention for a group of healthy animals that are at risk of becoming sick; and

* Growth promotion or increased feed efficiency in a herd or flock of animals to promote weight gain.

The primary solution to operating a stocker program or any livestock operation under the VFD is the establishment of a relationship with a large animal veterinarian. Every livestock operation is unique, and yours is no exception. Invite him or her to tour your operation so they can obtain a better understanding of your management practices. Let the veterinarian help in writing your herd health plan specific for your operation. These activities will prepare the veterinarian for writing necessary VFDs and make him or her an integral part of your business team.

There are many misconceptions in the beef cattle industry concerning the uses of antibiotics because they are complicated and are prone to change. It is important for stocker operators and other beef producers to stay up-to-date on how VFDs affect the business and to get information from correctly informed sources. This is not a subject on which to obtain information at the coffee shop unless you are visiting with someone who is schooled in application of the regulations.

Definitions used by the FDA>>>

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Definitions used by the FDA

Veterinary Feed Directive (VFD) - Defined as a written statement issued by a licensed veterinarian authorizing the use of a VFD drug in or on animal feed.

VFD Drug -  A drug intended for use in or on animal feed which is limited to use under professional supervision of a licensed veterinarian.

Combination VFD Drug - An approved combination of new animal drugs intended for use in or on animal feed under the professional supervision of a licensed veterinarian, and at least one is a VFD drug.

Medically Important Antibiotic – Drugs use in human medicine.

Veterinarians’ Responsibilities under the Antibiotic VFD (Source: FDA Fact Sheet):

* must be licensed to practice veterinary medicine;

* must be operating in the course of the veterinarian’s 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;

* must prepare and sign a 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 a drug 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);

* must provide the feed distributor with a copy of the VFD order;

* must retain the original VFD for two years; and

* must provide VFD orders for inspection and copying by FDA upon request.

(Source: FDA Fact Sheet)

Information required on a lawful VFD>>>

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Information required on a lawful VFD

What follows is the basic list of information that you must have for a legal VFD, based on information from an FDA fact sheet:

* veterinarian’s name, address, and telephone number;

* client’s name, business or home address, and telephone number;

* premises at which the animals specified in the VFD are located;

* date of VFD issuance;

* expiration date of the VFD;

* name of the VFD drug(s);

* species and production class of animals to be fed the VFD feed by the expiration date of the VFD;

* approximate number of animals to be fed the VFD feed by the expiration date of the VFD;

* indication for which the VFD is issued;

* level of VFD drug in the feed and duration of use;

* withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval;

* number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing;

* statement: “Use of feed containing this veterinary feed directive (VFD) drug in a  manner other than as directed on the labeling (extra label use), is not permitted”;

* an affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6); and

* veterinarian’s electronic or written signature.

(Source: FDA fact sheet)

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