Texas Agriculture March 4, 2016 : Page 12

Medicated feeds gain expanded regulations Veterinary oversight, prescrip-tions and a documented veterinary-client-patient relationship highlight changes farmers and ranchers will soon experience when handling med-icated feed for livestock or poultry. Starting Jan. 1, 2017, all feed-grade or water-soluble medically im-portant drugs for human health will be listed under the newly-expanded Veterinary Feed Directive (VFD). Pharmaceutical companies also have voluntarily changed label indi-cations for antibiotics. Products that were approved to increase weight gain or performance will no longer be available for those purposes. Those same products can still be used, but only if prescribed by a veterinarian to treat or prevent infection. written VFD orders from a licensed veterinarian to purchase and utilize the VFD antimicrobials on or in feed. When does the VFD rule become effective? This rule became effec-tive in October 2015 and must be fully implement-ed by Jan. 1, 2017. What are VFD drugs? VFD drugs are medically-important antimicrobials that are FDA-approved for use in animal feeds under veterinar-ian supervision and under written VFD orders. Currently (September 2015) there are three VFD drugs: florfenical (Nuflor, swine; Aquaflor, aquaculture); avilamycin (Kavault, swine); and tilmicosin (Pulmotil– swine, beef, dairy). Any new animal drug applications for feed delivery will automatically fall into the VFD category. By Jan. 1, 2017, all medically-im-portant antimicrobials intended for use in feed that are currently avail-able “over-the-counter” will become VFD drugs. Additives such as lasalo-cid (Bovatec, cattle; Avatec, poultry), monensin (Rumensin, cattle; Coban, poultry), bacitracin, bambermycins (Flavomycin, swine; Gainpro, cattle), and amprolium are not “medically-important” and will not fall under the VFD unless they are used in combination with a VFD drug. The label for the antimicrobial ad-ditive, or the label for the medicated feed item containing the antimicro-bial, will state whether the antimi-crobial is a VFD drug or not. Do producers need writ-ten authorization from a licensed veterinarian? Use of VFD drugs now falls under the supervision To write the VFD order, the licensed vet-erinarian must have an established veterinarian-client-pa-tient relationship (VCPR) with the producer. Based on the Texas Veteri-nary Licensing Act, a valid VCPR is present if: (1) The veterinarian assumes re-sponsibility for medical judgments regarding the health of the livestock, and the client (the owner or caretak-er of the livestock) agrees to follow the veterinarian’s instructions. (2) The veterinarian possesses sufficient knowledge of the livestock to initiate a general or preliminary diagnosis of the medical condition of the livestock. Sufficient knowledge exists if the veterinarian has recent-ly seen, or is personally acquainted with, the keeping and care of the livestock as a result of (a) examining the animal or (b) making medically appropriate and timely visits to the premises where the livestock are kept. A veterinarian-client-patient relationship may not be established solely by telephone or electronic means. (3) The veterinarian is readily available to provide follow-up medi-cal care in the event of an adverse reaction, or failure of the regimen of therapy. What are the steps to obtain a VFD order? (1) Contact your vet-erinarian with whom of licensed veterinarians. Produc-ers must receive signed and written (not verbal) authorization from a li-censed veterinarian to purchase and utilize VFD antimicrobials on and in feed. This authorization is referred to as a VFD order. Is an established vet-erinarian-client-patient relationship (VCPR) re-quired? you have a valid VCPR. If a produc-er does not have a valid VCPR with an appropriate veterinarian, then the preliminary step is to establish a VCPR. (2) The veterinarian determines whether conditions warrant use of a VFD drug or feed. (3) If warranted, the veterinarian issues a written and signed VFD or-der containing information specified by regulations. Verbal orders are not allowed. Incomplete and unsigned orders are invalid and cannot be filled. (4) The veterinarian retains a copy of the VFD order and gives the completed, signed original and a copy to the client. (5) The client keeps the copy and gives the original signed VFD to the feed mill/feed distributor supplying the VFD feed. The VFD order allows the feed to be released to the client. (6) Depending on the specific VFD drug, and the conditions outlined by the veterinarian, separate VFD or-ders may be required for different groups of livestock and new VFD or-ders may be required to extend the treatment duration (depends on “re-fill” specifications). What information is re-quired on a lawful VFD order? • Veterinarian’s name, address, and telephone number • Client’s name, business or home address and telephone number • Premises where the livestock specified in the VFD are located • Date the VFD was issued • Expiration date of the VFD (This is the date the VFD is no lon-ger valid and use of the VFD feed is illegal.) • Name of the VFD drug(s) in the order • Species and production class of livestock to receive the VFD feed • Approximate number of live-The Veterinary Feed Directive By F.T. McCollum III, PhD, PAS Texas A&M AgriLife Extension Service, Amarillo What does the VFD rule do? M ARCH 4, 2016 12 The VFD rule: (1) ends the use of medically-important an-timicrobials to enhance livestock performance; (2) transitions many of the feed medications that are currently avail-able “over-the-counter” into the VFD drug category; (3) places the use of VFD antimi-crobials in or on animal feed under the professional supervision of a li-censed veterinarian; (4) requires producers to obtain

Medicated Feeds Gain Expanded Regulations

Veterinary oversight, prescriptions and a documented veterinary-client-patient relationship highlight changes farmers and ranchers will soon experience when handling medicated feed for livestock or poultry.

Starting Jan. 1, 2017, all feed-grade or water-soluble medically important drugs for human health will be listed under the newly-expanded Veterinary Feed Directive (VFD).

Pharmaceutical companies also have voluntarily changed label indications for antibiotics.

Products that were approved to increase weight gain or performance will no longer be available for those purposes. Those same products can still be used, but only if prescribed by a veterinarian to treat or prevent infection.

The Veterinary Feed Directive

By F.T. McCollum III, PhD, PAS Texas A&M AgriLife Extension Service, Amarillo

What does the VFD rule do?

The VFD rule:

(1) ends the use of medically-important antimicrobials to enhance livestock performance;

(2) transitions many of the feed medications that are currently available “over-the-counter” into the VFD drug category;

(3) places the use of VFD antimicrobials in or on animal feed under the professional supervision of a licensed veterinarian;

(4) requires producers to obtain written VFD orders from a licensed veterinarian to purchase and utilize the VFD antimicrobials on or in feed.

When does the VFD rule become effective?

This rule became effective in October 2015 and must be fully implemented by Jan. 1, 2017.

What are VFD drugs?

VFD drugs are medically-important antimicrobials that are FDA-approved for use in animal feeds under veterinarian supervision and under written VFD orders. Currently (September 2015) there are three VFD drugs: florfenical (Nuflor, swine; Aquaflor, aquaculture); avilamycin (Kavault, swine); and tilmicosin (Pulmotil– swine, beef, dairy). Any new animal drug applications for feed delivery will automatically fall into the VFD category.

By Jan. 1, 2017, all medically-important antimicrobials intended for use in feed that are currently available “over-the-counter” will become VFD drugs. Additives such as lasalocid (Bovatec, cattle; Avatec, poultry), monensin (Rumensin, cattle; Coban, poultry), bacitracin, bambermycins (Flavomycin, swine; Gainpro, cattle), and amprolium are not “medically-important” and will not fall under the VFD unless they are used in combination with a VFD drug.

The label for the antimicrobial additive, or the label for the medicated feed item containing the antimicrobial, will state whether the antimicrobial is a VFD drug or not.

Do producers need written authorization from a licensed veterinarian?

Use of VFD drugs now falls under the supervision of licensed veterinarians. Producers must receive signed and written (not verbal) authorization from a licensed veterinarian to purchase and utilize VFD antimicrobials on and in feed. This authorization is referred to as a VFD order.

Is an established veterinarian-client-patient relationship (VCPR) required?

To write the VFD order, the licensed veterinarian must have an established veterinarian-client-patient relationship (VCPR) with the producer. Based on the Texas Veterinary Licensing Act, a valid VCPR is present if:

(1) The veterinarian assumes responsibility for medical judgments regarding the health of the livestock, and the client (the owner or caretaker of the livestock) agrees to follow the veterinarian’s instructions.

(2) The veterinarian possesses sufficient knowledge of the livestock to initiate a general or preliminary diagnosis of the medical condition of the livestock. Sufficient knowledge exists if the veterinarian has recently seen, or is personally acquainted with, the keeping and care of the livestock as a result of (a) examining the animal or (b) making medically appropriate and timely visits to the premises where the livestock are kept. A veterinarian-client-patient relationship may not be established solely by telephone or electronic means.

(3) The veterinarian is readily available to provide follow-up medical care in the event of an adverse reaction, or failure of the regimen of therapy.

What are the steps to obtain a VFD order?

(1) Contact your veterinarian with whom you have a valid VCPR. If a producer does not have a valid VCPR with an appropriate veterinarian, then the preliminary step is to establish a VCPR.

(2) The veterinarian determines whether conditions warrant use of a VFD drug or feed.

(3) If warranted, the veterinarian issues a written and signed VFD order containing information specified by regulations. Verbal orders are not allowed. Incomplete and unsigned orders are invalid and cannot be filled.

(4) The veterinarian retains a copy of the VFD order and gives the completed, signed original and a copy to the client.

(5) The client keeps the copy and gives the original signed VFD to the feed mill/feed distributor supplying the VFD feed. The VFD order allows the feed to be released to the client.

(6) Depending on the specific VFD drug, and the conditions outlined by the veterinarian, separate VFD orders may be required for different groups of livestock and new VFD orders may be required to extend the treatment duration (depends on “refill” specifications).

What information is required on a lawful VFD order?

• Veterinarian’s name, address, and telephone number

• Client’s name, business or home address and telephone number

• Premises where the livestock specified in the VFD are located

• Date the VFD was issued

• Expiration date of the VFD (This is the date the VFD is no longer valid and use of the VFD feed is illegal.)

• Name of the VFD drug(s) in the order

• Species and production class of livestock to receive the VFD feed

• Approximate number of livestock to receive the VFD feed by the expiration date

• Health indication for which the VFD was issued

• Concentration of VFD drug in the feed

• Duration of use (length of time the livestock will receive the treatment)

• Withdrawal time, special instructions and cautionary statements necessary for use of the drug to conform with the approval

• Number of reorders (refills) authorized, if permitted

• Statement: “Use of feed containing this veterinary feed directive drug in a manner other than as directed on the labeling (extralabel use) is not permitted”

• Veterinarian’s electronic or written signature

The following information is optional:

• More specific description of the location (i.e. pen, barn, pasture or other)

• Approximate age range of the animals

• Approximate weight range of the animals

• Any other information the veterinarian deems appropriate to identify the animals involved

Basic producer responsibilities:

• Establish a VCPR with an appropriate veterinarian.

• Contact your veterinarian for consultation and guidance.

• Follow your veterinarian’s recommendations.

• Administer the VFD medicated feed according to the directions on the VFD order.

• Keep copies of your VFD orders for at least two years.

• Provide your VFD order copies for FDA inspectors to copy and review, if requested.

Read the full article at http://texasagriculture.texasfarmbureau.org/article/Medicated+Feeds+Gain+Expanded+Regulations/2414555/292602/article.html.

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