RETAILERS AND MILLS

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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 (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.