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Veterinary Feed Directive Information (VFD)
Introduction
On December 11, 2013, the FDA published information that outlined steps the feed industry must take to reduce the use of targeted antibiotic drugs in medicated feed for food animals. These steps significantly change the way targeted antibiotic drugs can be used in animal agriculture. Consequently, the FDA has compiled a list of drugs (hereafter referred to as the "FDA's List") that will no longer be allowed to be used for growth promotion or feed efficiency, effective January 1, 2017. The noted drugs on the FDA's List will continue to be labeled for disease prevention, control, and/or treatment but will require a Veterinary Feed Directive (VFD) for use effective January 1, 2017.

For more information about why the FDA made these changes, click here to visit the FDA's website.

What drugs are affected by these changes?
The following drugs are the targeted antibiotic drugs on the FDA's List and will require a VFD for use effective January 1, 2017.

FDA's list of Drugs Transitioning from the Over-the-Counter (OTC) to VFD Status


Established drug name Examples of proprietary drug name(s)$
chlortetracycline (CTC) Aureomycin, CLTC, CTC, Chloratet, Chlorachel, ChlorMax, Chlortetracycline, Deracin, Inchlor, Pennchlor, Pfichlor
chlortetracycline/sulfamethazine* Aureo S, Aureomix S, Pennchlor S
chlortetracycline/sulfamethazine/penicillin* Aureomix 500, Chlorachel/Pficlor SP, Pennchlor SP, ChlorMax SP
hygromycin B Hygromix
lincomycin Lincomix
oxytetracycline (OTC) TM, OXTC, Oxytetracycline, Pennox, Terramycin
oxytetracycline/neomycin* Neo-Oxy, Neo-Terramycin
penicillin+ Penicillin, Penicillin G Procaine
sulfadimethoxine/ormetoprim* Rofenaid, Romet
tylosin Tylan, Tylosin, Tylovet
tylosin/sulfamethazine* Tylan Sulfa G, Tylan Plus Sulfa G, Tylosin Plus Sulfamethazine
virginiamycin Stafac, Virginiamycin, V-Max


Note: apramycin, erythromycin, neomycin (alone), oleandomycin+, sulfamerazine, and sulfaquinoxaline are also approved for use in feed and are expected to transition to VFD status, but are not marketed at this time. If they return to the market after January 1, 2017, they will require a VFD.

$Type A Medicated Articles used to manufacture medicated feed, all products may not be marketed at this time

*Fixed-ratio, combination drug
+Currently only approved for production uses

These drugs already require a VFD for use:

Established drug name Proprietary drug name(s)**
avilamycin Kavault
florfenicol Aquaflor, Nuflor
tilmicosin Pulmotil, Tilmovet
tylvalosin Aivlosin



**Type A medicated articles used to manufacture medicated feed
This information is up-to-date as of January 19, 2016. As the industry transitions, CVM anticipates additional changes during the coming months to this information. Please check the link below for the most recent updates:

http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

Click here for a printer-friendly version of the FDA's List.

Wondering which drugs won't require a VFD for use? Click here.

What's Changing?
Feeds medicated with drugs on the FDA's List, will no longer be labeled for increased rate of gain and/or improved feed efficiency
  • Medicated feeds that are labeled with only production claims will no longer be sold
  • Feeds labeled with both a production claim and a treatment, prevention or control claim will be changed to eliminate the production claim
Medications can only be used for treatment, control or prevention purposes
  • Treatment: Animals are showing clinical signs
  • Control: Percentage of animals are sick but the rest are healthy
  • Prevention: Animals are at risk or have been exposed with no clinical signs
  • Note: It will be illegal to use these medicated feeds for production purposes

A producer must have a Veterinary Feed Directive (VFD), from their veterinarian, to use a feed medicated with a drug on the FDA's List
  • This includes all feed product types (complete feeds, supplements, premixes, liquid feeds, milk replacers, etc.)

When will these changes take effect?
January 1, 2017 is when feeds medicated with a drug on the FDA's List will require a VFD for use and production uses of these drugs will become illegal.

What do the changes mean to me?
If you're an animal producer:
  • The VFD regulations consider you to be the "client-recipient"
  • You will need to have a lawful VFD from your veterinarian in order to feed your animals a VFD-medicated feed effective January 1, 2017
  • Click here for more information for animal producers and the VFD process
If you sell VFD drugs or VFD-medicated feeds:
  • The VFD regulations consider you to be a "distributor"
  • You must have the correct documentation from your customers when you sell them a VFD drug or VFD-medicated feed
  • Click here for more information for distributors and the VFD process
If you are a veterinarian writing a VFD
  • Click here for more information for veterinarians and the VFD process
Recordkeeping Requirements
Everyone involved in a VFD transaction is required to keep records and make them available to the FDA upon request.

What records are distributors required to keep?
A distributor is required to keep receiving and distribution records for VFD drugs and VFD-medicated feeds for 2 years. A distributor is also required to maintain records for VFD orders for 2 years from date of issuance. A distributor that manufactures VFD feeds, is also required to keep VFD-medicated feed production records for 1 year.

What records are producers required to keep?
A producer must keep their copy of the VFD and corresponding feeding instructions for 2 years.

What records are veterinarians required to keep?
The veterinarian must retain the original VFD in its original form (electronic or hard copy) for at least 2 years.

Extra-label Use
Extra-label use is when a drug is used in any way that is different from what's been approved by the FDA for that specific drug, species, production class, drug level, purpose, etc. Extra-label use of medicated feeds, including VFD-medicated feeds, is illegal.

Example of extra-label use include but are not limited to:
  • Feeding the VFD-medicated feed for any other purpose than what's listed on the product label and VFD form
  • Feeding the animals for longer than the duration of use stated on the label and VFD form
  • Feeding a VFD-medicated feed at a drug level that is different from what's specified on the label and the VFD form
  • Feeding the VFD-medicated feed to an animal species or production class that isn't specified on the product label and the VFD form
What should you do right now?
It is imperative to understand how these changes will affect your business.

If you're a producer:
  • Effective January 1, 2017, your must have a VFD from your veterinarian in order to feed your animals a VFD-medicated feed and it will be illegal to use VFD-medicated feeds for production purposes
  • Talk to your veterinarian about your management practices, including what medicated feeds you're currently using, and establish a herd health history with the veterinarian so that when a VFD is needed in the future, you both understand what is required.
If you're a distributor:
  • Identify the products that you sell that will require a VFD for use effective January 1, 2017
  • If you plan to continue distributing VFD products, notify the FDA of your intent to distribute through the Distributor Notification Process
  • Develop a plan to ensure that you are compliant with the distributor requirements
If you're a veterinarian:
  • Understand what drugs and medicated feed uses will require a VFD effective January 1, 2017
  • Talk to your clients about their current management practices and work together to develop a plan for what you'll both need to do when a VFD is needed
For more information:

FDA's Veterinary Feed Directive page
FDA's VFD Requirements for Distributors Who Do Not Manufacture Feed page
FDA's VFD Requirements for Distributors Who Manufacture Feed page
FDA's VFD Requirements for Veterinarians page
FDA's VFD Requirements for Producers page

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