Veterinary Feed Directive

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VFD_Retailers_New_Button  VFD_Vet_New_Button  VFD_Youth_Page_Button


Basic information about the Veterinary Feed Directive:

Historically, the Food and Drug Administration (FDA), who regulates the use of medicine in animals, has allowed select antibiotics used in or on animal feeds to be available to producers over-the-counter and without the direct supervision of a licensed veterinarian. In 1999, the Animal Drug Availability Act (ADAA) of 1996 implemented a new category of drugs called veterinary feed directive (VFD). The VFD category is a part of the FDA’s overall directive to ensure the judicious use of human medically important antibiotics. Recently, the VFD category was expanded to include medically important antibiotics fed to animals and is defined in FDA Guidance Document #213. The revised VFD policy puts into place important control factors that dictate the appropriate use of feed-grade antibiotics.

In the past they have allowed antibiotics to have label claims for therapeutic (prevention, control, treatment) reasons, growth promotant and feed efficiency. As a part of judicious use strategy, the FDA has aligned with drug sponsors to voluntarily revise label claims, removing growth promotant and feed efficiency. Since these products cannot be used extra-label, and the removal of label claims will discontinue their use for non-therapeutic purposes. This action will result in some feed products being withdrawn from retail.

What is a VFD drug?

Drug classifications and methods of distribution are determined by the FDA. A VFD drug is a medically important (determined by the FDA) antibiotic that has been approved for use in or on animal feed. To use feed containing a VFD drug, a written order by a licensed veterinarian is required.

 

What is a VFD order?

A VFD order is a written statement issued by a licensed veterinarian that gives producers permission to use feed that contains antibiotics, as it is written by the licensed veterinarian. A requirement of the VFD policy is that a Veterinarian Client Patient Relationship (VCPR) must be in place.

 

All VFD orders must be kept in their original form (either written record or electronic copy) by the issuing veterinarian and a copy must be retained by the producer and feed distribution company. Both original and copies must be retained for two years.

 

What is a VCPR?

A veterinarian-client-patient relationship (VCPR) is a working relationship between a veterinarian and a producer. The veterinarian’s primary role is to advise and guide the producer (the client) in determining which medications are appropriate for their animals (the patients).

 

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.

 

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 , water soluble antibiotics, which are important to human medicine now require a prescription from a veterinarian. A list of drugs transitioning from over-the-counter to prescription status can be found on the FDA’s website.

 

What products does the VFD cover?

Medically important antibiotics, which are essential to human medicine as outlined in Guidance Document 213, are being added to the list of drugs being moved to VFD status. This includes products that contain: tetracyclines, lincosamides, macrolides, penicillin, streptogramins, aminoglycosides, aminopenicillins and sulfonamides. The FDA maintains and updates a list of drugs transitioning from over-the-counter to VFD status on their website.

 

Where can I find a list of VFD drug distributors?

You can fill a VFD order at any mill, retailer or other establishment who is listed as a distributor with the FDA, find the list of companies on their website listed alphabetically or listed by state.

 

Resources

 

Questions? Please contact our MDARD feed expert by email at lyonst1@michigan.gov or by phone at 800-292-3939 or find more information on our “Producer,” “Retailer and Mills” and “Veterinarian” pages above.

FAQ
VFD Resources
YOUTH

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VFD_Retailers_New_Button VFD_Vet_New_Button  VFD_Youth_Page_Button


To ensure a safe food supply, the Food and Drug Administration (FDA) oversees the use of animal medications. Some medications have been approved for use without a veterinarian's permission, while others require permission. Recently, the FDA changed how some antibiotic medications, which are important to human medicine, are used for animal feed. After January 1, 2017, these medications will require a Veterinary Feed Directive (VFD) order to be used in a medicated feed.

What is a medicated feed and why is it used?

Medicated feed is feed with a specific drug added to it. Medicated feed is fed to animals to prevent illness or treat an animal when it is sick. Medicated feeds are just one of the good animal care and well-being practices farmers and animal owners use to keep their animals healthy.

Is all feed medicated?

No, when you purchase feed, you have the option to buy feed without medications mixed into it.

Who is impacted by these changes?

Livestock owners, including youth with animal projects, who have decided to feed their animals medicated feeds.

What is a VFD drug and why did the FDA change their process?

A VFD drug is an antibiotic used for both human and animal medicine. It’s important these drugs are used correctly. The FDA’s job is to ensure these drugs are used properly which is why they are requiring a VFD order for some medicated feed beginning January 1, 2017.

Are all antibiotics affected?

No, not all antibiotics will be considered VFD drugs. The use of injectable antibiotics will not be affected; and some drugs used in water will now require a prescription from a veterinarian.

How does a VFD order work?

A VFD order is similar to a prescription you would get from your human doctor, however a veterinarian will be giving you a VFD order for a medicated feed.

How do you get a VFD order?

To get a VFD order, you must have an established veterinarian-client-patient relationship (VCPR) with a veterinarian. A VCPR is a working relationship between a veterinarian and a person who raises livestock (client). The veterinarian’s primary role is to help and advise the client in determining which medications are appropriate for their animals (the patients).

How do you know if you need a VFD order?

As seen in the example, feed labels of VFD drugs have the following statement: “Caution: Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian.”

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What are examples of medications that will require a VFD order?

Examples of feed-grade medications moving to VFD drug status are chlortetracycline, tylosin and penicillin. The detailed list can be found on the FDA’s website.

Where can I buy feed with my VFD order?

You can buy VFD feeds at any mill, retailer or other establishment listed as a distributor or manufacturer with the FDA. If you are purchasing feed that requires a VFD order, you will need to present the VFD order before purchase.

How do feed stores check for VFD orders?

Previously, VFD feeds were purchased without documentation at your feed store or mill. However, starting January 1, 2017, you must first present a VFD order, written by a veterinarian, to purchase VFD feeds.

What records will I need to keep?

Records will need to be kept by the livestock owner, veterinarian and feed sales company for two years. The original VFD order will be kept by the veterinarian. The livestock owner and feed mill must also keep copies on file.

 

PRODUCERS

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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.

How will the Veterinary Feed Directive (VFD) impact producers?

Because drug companies have voluntarily removed label claims for enhancing growth or improving feed efficiency from feed labels, there will be some feeds, which will no longer be sold. However, feed-grade antibiotics will be available to use for therapeutic (prevention, control, treatment) reasons, under the direction of a veterinarian with a VFD order. Producers will have to work with their veterinarian to determine the best course of treatment for their animals on a case by case basis.

Are all antibiotics now considered VFD drugs?

Not all antibiotics will be considered VFD drugs. The use of Injectable antibiotics will not be affected by the revised act. 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 water soluble antibiotics, which are important to human medicine now require a prescription from a veterinarian.

What is a VFD drug?

Drug classifications and methods of distribution are determined by the FDA. A VFD drug is a medically important (determined by the FDA) antibiotic that has been approved for use in or on animal feed. In order to use feed containing a VFD drug a written order by a licensed veterinarian is required.

What is a VCPR?

A veterinarian-client-patient relationship (VCPR) is a working relationship between a veterinarian and a producer. The veterinarian’s primary role is to advise and guide the producer (the client) in determining which medications are appropriate for their animals (the patients).

What do producers need to do to follow the veterinary feed directive?

In order to be compliant, producers must only feed VFD drugs to animals if they have a valid veterinarian-client-patient-relationship (VCPR) with a licensed veterinarian and such veterinarian gives them a VFD order. Producers must completely feed the VFD drug feed prior to the expiration date on the VFD order and keep a copy of the VFD order for two years. If inspected by the Food and Drug Administration (FDA), producers must be able to provide VFD orders for FDA inspections, when requested.

How do producers get a VFD drug or prescription?         

Producers must work with a licensed veterinarian, which they have an established VCPR with. The veterinarian will write either a prescription for antibiotics delivered through water or a VFD order for antibiotics delivered through feed to treat their animals.

How do producers know if a drug is a VFD drug?

Labels of VFD drugs must have the the following 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." The FDA maintains and updates a list of drugs transitioning from over-the-counter to VFD status on their website.

What is a VFD order?

A VFD order is a written statement issued by a licensed veterinarian that gives producers permission to use feed that contains antibiotics, as it is written by the licensed veterinarian. A requirement of the VFD policy is that a VCPR must be in place.

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. In order for feed mills to fill requests for medicated feed a current VFD order must be on file.

Once producers have a VFD order where can it be filled?

You can fill a VFD order at any mill, retailer or other establishment who is listed as a distributor with the FDA, find the list of companies on their website listed alphabetically or listed by state.

 

Resources

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

RETAILERS AND MILLS

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VFD_Retailers_New_Button VFD_Vet_New_Button  VFD_Youth_Page_Button


When will this take effect?

The expansion of the order went into effect on October 1, 2015, however, only a small number (tilmicosin, florfenicol, and avilamycin) of antibiotics 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 my role in the Veterinary Feed Directive (VFD) process?

Retailers and mills, also known as distributors, are responsible for making sure the VFD order is completely filled out, monitoring that reasonable amounts of feed are being ordered for the time and animals specified on the VFD order, properly labeling VFD drug feeds - including directions for use and ensuring the feed is mixed appropriately. Distributors must keep a copy of all VFD orders for two years. Unless the distributors record-keeping system is part 11 compliance, VFD orders received electronically must be printed out when filed.

How do retailers and mills know if a drug is a VFD drug?

Labels of VFD drugs must have the the following 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." The FDA is also maintaining a list of VFD drugs on their website, for the most up-to-date version please click here.

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 must a distributor do to be approved to sell medicated feeds requiring a VFD?

In order to fill a VFD order, three documents are required:  

  • A One-time Distributor Notice
    • Notice to FDA of intent to distribute VFD drugs
    • This notice will put you on the FDA’s national distributor list
    • The notice is a contract between FDA and the distributor
    • According to the FDA the notice must include the following:
      • The distributor's complete name and business address;
      • The distributor's signature or the signature of the distributor's authorized agent; and
      • The date the notification was signed.
  • The notification should be mailed to: Food and Drug Administration Center for Veterinary Medicine Division of Animal Feeds (HFV-220) 7519 Standish Place Rockville, MD 20855
  • If the ownership, name, or address of a distributor changes, the FDA must be notified within 30 days.
  • Acknowledgement Letter
    • The acknowledgment letter is sent to the company that is supplying the VFD drug to the distributor
    • The acknowledgment letter states that the distributor will:
      • Only release the VFD drug to a client with a VFD order
      • Not send a VFD drug to another distributor without having received an acknowledgement letter
  • The VFD
    • The VFD order is provided by a veterinarian and is needed in order for a distributor to release a VFD drug or mixed feed with a VFD drug to someone who is not a distributor.

Being a distributor allows a facility to have a VFD drug or mixed feed with a VFD drug on hand so that when a valid VFD order is received the distributor can fill the VFD order immediately. If the above documents are in place, anyone can be a distributor, however distributors are more open to FDA and state inspection.  

Resources

***As a reminder***

Anyone who mixes/manufactures feeds and sells it must be licensed in the state of Michigan.

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

VETERINARIANS

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VFD_Retailers_New_Button VFD_Vet_New_Button  VFD_Youth_Page_Button


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.”

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.