Veterinary Feed Directives: What Feed Mill Operators and Distributors Should Know
In 1996, Congress passed the Animal Drug Availability Act (ADAA). The ADAA created a new regulatory category for distribution of certain medicated feeds, the Veterinary Feed Directive (VFD). The law now allows VFD drugs to be administered in animal feed under a veterinarian's order and professional supervision. Producers can now obtain and use critically needed drugs while the Food and Drug Administration (FDA) ensures the protection of public health. Examples of new animal drugs approved so far as VFD drugs include Aquaflor® (florifenicol), for use in catfish and freshwater-raised salmonid fish, and Pulmotil® 90 (tilmicosin), for use in pigs.
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.
Required VFD Order Information
To be valid, a VFD order must include the following information:
- veterinarian's name, address, and telephone number,
- veterinarian's 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 (if any),
- 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 on the form.
Under Title 21, Part 558.6(a)(3), of the Code of Federal Regulations (21 CFR 558.6), a veterinarian "must complete the VFD in writing and sign it." You should NOT FILL incomplete VFD orders because they are invalid. We recommend that you contact the veterinarian for a complete order. Remember, the veterinarian is responsible for the completeness and accuracy of the VFD order.
Receiving VFD Orders
You will receive one of two types of VFD orders:
1. Paper VFD Orders
For paper VFD orders, the hand-signed written VFD order is considered the "original signed VFD" order. Veterinarians are required to provide this paper order to you within FIVE working days.
Scanned and emailed, or faxed VFD orders from veterinarians are not true electronic VFDs due to their lack of authorized electronic signatures. Therefore, when a veterinarian sends you copies of VFD orders in one of these ways, he or she must send their original hand-signed VFD order to you within five working days.
2. Electronic VFD Orders (eVFDs)
Electronic VFD orders, or "eVFD" orders, are VFD orders sent via the Internet using a computer system that is compliant with 21 CFR 11. Because an eVFD order is signed with the veterinarian's 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.
Basic Feed Mill Operator/Distributor Responsibilities
Under the VFD program you, like the producers, are responsible for the following:
- Keeping all original VFD orders for two years from the date of issue;
- If inspected, providing FDA with all VFD order forms you have on file;
- Submitting a one-time Distributor Notification Letter to the FDA stating that you intend to distribute VFD drug-containing medicated feeds;
- Keeping acknowledgement letters from all purchasers of VFD feeds who are not the end-users of the VFD feeds. The letters should state that the purchasers will only sell the VFD feeds to producers with valid VFD orders or to other distributors for whom they have acknowledgement letters.
- Ensuring that all labels and advertisements for the VFD feeds you distribute contain the following statement verbatim:
"Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice."
- Maintaining a valid FDA Feed Mill License Application (Form 3448) and renewing it electronically each year (Form 2656).
- Keeping current, approved Type B and/or Type C Medicated Feed labels for each Type B and/or Type C Medicated Feed you will be making before you receive the VFD drug-containing Type A Medicated Article.
- Notifying the FDA within 30 days when you make changes to your business name or address.
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.