Veterinary Feed Directives: What Veterinarians Should Know
In 1996, Congress passed the Animal Drug Availability Act (ADAA). The ADAA established a new regulatory category for restricted feed-use drugs, the Veterinary Feed Directive (VFD). The law allows VFD drugs to be administered in animal feed under a licensed veterinarian's order and professional supervision. This way, producers can obtain and use critically needed approved new animal drugs, while the Food and Drug Administration (FDA) can further ensure the protection of public health.
What are VFD Drugs?
- are drugs that FDA approved for use in animal feeds, and
- are used under veterinarian supervision and issued under written veterinary feed directive orders.
Extra-label use (i.e., use of VFD feed for unapproved indications or at unapproved doses), is strictly prohibited.
When authorizing use of feed containing VFD drugs, i.e., issuing VFD orders, you are responsible for the following:
- being appropriately-licensed (i.e., you have a valid veterinary license in the State where the animals to be treated are located),
- having a valid Veterinarian-Client-Patient relationship,
- completely and accurately filling-out and signing VFD orders,
- electronically signing electronic VFD (eVFD) orders (when applicable),
- providing the feed distributor with the original VFD order,
- giving a copy of the VFD or eVFD order to the producer,
- keeping copies of VFD orders for a minimum of TWO years, and
- having VFD orders available when inspected by FDA.
Sending VFD Orders
You can send VFD orders in one of the following two ways:
1. Paper VFD Orders
For paper VFD orders, the written VFD order that you hand-sign is considered the "original signed VFD" order. If the signed order is faxed to the feed mill distributing the feed or to another distributor, you are required to provide the distributor with the hand-signed paper order within FIVE working days.
Copies of your VFD order, whether scanned and emailed, or faxed to the feed mill or to another distributor, are not true electronic VFDs due to their lack of authorized electronic signatures. Therefore, when you send copies of your VFD orders in one of these ways, you must provide your original hand-signed VFD order to the feed mill operator or distributor within five working days.
2. Electronic VFD Orders (eVFDs)
Electronic VFD orders, or "eVFD" orders are VFD orders send via the Internet using a computer system that is compliant with Title 21, Part 11 of the Code of Federal Regulations (21 CFR 11). Because the eVFD order is signed with your authorized electronic signature, the eVFD order is considered the "original signed VFD", and no follow up paper copy is needed.
Telephone orders are not allowed.
VFD Form Requirements
VFD drug sponsors are not required to provide you with VFD order forms. You may develop your own VFD order form, which, to be valid, should including the following information:
- your name, address, telephone number, and fax number,
- your veterinary license number and State where issued,
- client's name, address, and telephone number,
- species and number of animals being treated,
- animals' identification numbers/descriptions,
- animals' location,
- date of treatment and the date the VFD order is issued,
- name of animal drug,
- drug's approved or index-listed indications for use,
- level of drug in the feed and amount of feed required to treat animals,
- feeding instructions,
- withdrawal time (if applicable),
- any special instructions and caution statements,
- VFD order's expiration date,
- number of refills (reorders) permitted by the drug's approval regulation,
- the following statement verbatim: "Extra-label use (i.e., use of this VFD feed in a manner other than as provided for in the VFD drug approval) is strictly prohibited", and
- any other information that the VFD drug's approval regulation requires you to include on the form.
Under 21 CFR 558.6, a veterinarian "must complete the VFD in writing and sign it." VFD orders that are incomplete or unsigned are considered invalid. Feed mill operators and distributors will not fill incomplete or unsigned VFD orders. Remember, you are responsible for the accuracy and completeness of the information in the VFD order. If you initially used a copy to authorize the use of VFD feed, make sure the original paper order is given to the feed mill operator or distributor within the 5-working-day timeframe.
This summary highlights the main concepts regarding VFD drugs. More in-depth information can be found in Guidance for Industry #120: Veterinary Feed Directive Regulation Questions and Answers.
For additional information, contact the FDA Center for Veterinary Medicine's (CVM) Communications Staff by phone at 240-276-9300 or through the CVM Home Page at http://www.fda.gov/AnimalVeterinary.
FDA thanks the following American Veterinary Medical Association groups for their assistance in reviewing this summary: Aquatic Veterinary Medicine Committee, Council on Biologic and Therapeutic Agents, Clinical Practitioners Advisory Committee, and Council on Public Health and Regulatory Veterinary Medicine.