VETERINARIANS

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When will this take effect?

The expansion of the order went into effect on October 1, 2015, however, only a small number of antibiotics (tilmicosin, florfenicol, and avilamycin) were affected. Full implementation of FDA Guidance #213 including phasing numerous over-the-counter feed-grade antibiotics to VFD status will take place on January 1, 2017.

What is a VFD order?

According to the Food and Drug Administration (FDA), a veterinary feed directive (VFD) is “a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that authorize the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client’s animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the FDA.”

What is a considered a valid VCPR?

Michigan currently follows the federal definition for a veterinarian-client-patient-relationship (VCPR) which states that a VCPR is considered valid if the following is observed (Code of Federal Regulations 530.3):  “

  1. A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;
  2. There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and
  3. The practicing veterinarian is readily available for followup in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.”

What is my role in the VFD process?

As a veterinarian, it is your responsibility to verify that a valid VCPR with the client receiving the VFD order exists. You also should ensure that the order is written correctly and the appropriate information is included in the order. Lastly, veterinarians are primarily responsible for distributing copies of the VFD order to the correct parties and maintaining records for a minimum of two years.

What do I need to have in place to issue a VFD order?

The veterinarian must have a valid VCPR with the client receiving the VFD order, be licensed in the same state as the receiving client and be in compliance with all state and federal regulations.

What information has or can be included in a lawful VFD order?

Mandatory:

  • 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 order are located;

  • date of VFD order issuance;

  • expiration date of the VFD order;

  • name of the VFD drug(s);

  • species and production class of animals to be fed the VFD drug feed;

  • approximate number of animals to be fed the VFD drug feed by the expiration date of the VFD order;

  • indication for which the VFD order 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 (extralabel use), is not permitted”;

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

  • veterinarian’s electronic or written signature;

  • and the veterinarian must keep the original VFD order for two years

Optional:

  • a more specific description of the location of the animals (for example, by site, pen, barn, stall, tank, or other descriptor the veterinarian deems appropriate);

  • the approximate age range of the animals;

  • the approximate weight range of the animals; and any other information the veterinarian deems appropriate to identify the animals at issue.

  • May choose to write the generic drug name

  • May choose to specify that a substitution of a drug is not allowed. If not specified the deed distributor may choose to substitute if the generic VFD drug is part of an approved combination VFD drug

When do I need to write separate VFD orders?

A separate VFD order needs to be written for each individual drug or drug combination for each specific group of animals.

What is an extralabel use of a VFD drug and is it allowed?

Extralabel use of medicated feed, including medicated feed containing a VFD drug or a combination VFD drug, is not permitted. This would include feeding a VFD drug in an off label dosage or to an animal species different than what is specified on the label, among other alterations.

When can I authorize a reorder (refill)?

A VFD Order refill/reorder is based on the drug manufacturer’s label.  Please follow the manufacture’s label, if the label is silent on refills they are not allowed. As a reminder, the maximum amount of time a VFD Order can be written for is six months.

What is a combination VFD drug?

According to the FDA a combination VFD drug is when two or more antimicrobials are used in or on animal feed and at least one of the antimicrobials is an approved VFD drug. An example would be oxytetracycline and monensin.

Are all antibiotics now considered VFD drugs?

Not all antibiotics will be considered VFD drugs. The use of Injectable antibiotics will not be affected. At this time, the FDA has only moved antibiotics that are essential to human medicine and being fed to animals, to VFD status.

According to FDA Guidance Document #213 located here water soluble antibiotics, which are important to human medicine now require a prescription from a veterinarian.

Who gets a copy of the VFD order?

The veterinarian retains the original VFD order and gives a copy to both the distributor filling the order and the producer. Both original and copies must be retained for two years.

What is the expiration date on the VFD order?

The expiration date on the VFD order is the last day the VFD feed can be fed and the duration of the order is not to exceed six months.

What is the difference between an expiration date on the VFD order and duration of use?

According to the FDA, while the VFD order “expiration date defines the period of time for which the authorization to feed an animal feed containing a VFD drug is lawful, the duration of use determines the length of time, established as part of the approval, conditional approval, or index listing process, that the animal feed containing the VFD drug is allowed to be fed to the animals.”

Where can I find examples of approved drug labels?

 

VFD orders should be written to reflect the FDA’s approved use for certain drug or drug combinations for the particular species, including the caution and warning statements that are required per labeling instructions. To ensure you are correctly filling out the VFD order, FDA provides approved label examples called “Blue Bird Labels.”

 

Resources

Where can I get more information?

For more detailed information on the VFD policy, please visit the FDA’s website.

Questions? Please contact our MDARD feed expert by email at lyonst1@michigan.gov or by phone at 800-292-3939.