VFD Frequently Asked Questions
How long must VFD orders be kept, and who must keep them?

All involved parties (veterinarian, client, distributor) must retain a copy of the VFD for 2 years. The veterinarian is required to keep the VFD in its original format. The distributor and client copies may be kept as an electronic copy or hardcopy (21 CFR 558.6(a)(4)).

What should the distributor do if the VFD is not completely filled out?

The veterinarian must ensure that all required information is fully and accurately included on the VFD (21 CFR 558.6(b)(3)). The distributor is permitted to fill a VFD only if the VFD contains all required information (21 CFR 558.6(c)(1)). If it does not contain all of the required information, the distributor must not fulfill the VFD and we recommend that the distributor notify the veterinarian that the order cannot be filled until all the necessary information on the VFD is provided.

What is an “extralabel use” of a VFD drug, and is it allowed?

“Extralabel use” is defined in FDA regulations as actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling (21 CFR 530.3(a)). For example, feeding the animals VFD feed for a duration of time that is different from the duration specified on the label, feeding VFD feed formulated with a drug level that is different from what is specified on the label, or feeding VFD feed to an animal species different than what is specified on the label would all be considered extralabel uses.

Extralabel use of medicated feed, including medicated feed containing a VFD drug or a combination VFD drug, is not permitted (21 U.S.C. 360b(a); 21 CFR 530.11(b) and 558.6(a)(3)). Use of medicated feeds, including those containing a VFD drug or a combination VFD drug, is limited to the approved, conditionally approved, or indexed conditions of use (21 U.S.C. 360b(a); 21 CFR 558.6(a)(3)).

Can a VFD authorize either the approved pioneer or approved generic VFD drug(s)?

The veterinarian is required to write the name of the VFD drug on the VFD (21 CFR 558.6(b)(3)(vi)). The veterinarian may choose to write the trade name of the approved pioneer or an approved generic (if available) VFD drug or the established name of the VFD drug (i.e., active drug ingredient) to complete this requirement. The veterinarian may choose to specify that a substitution by the feed manufacturer of either the pioneer or generic VFD drug identified on the form is not allowed. If the veterinarian does not specify that a substitution is not allowed, the feed manufacturer may use either the approved pioneer or an approved generic VFD drug to manufacture the VFD feed. However, the feed manufacturer may not substitute a generic VFD drug for a pioneer VFD drug in a combination VFD feed if the generic VFD drug is not part of an approved combination VFD drug.

How can producers and veterinarians address anaplasmosis concerns in cattle?

We realize that anaplasmosis in cattle is a significant animal health issue and would like to remind all affected parties that the following FDA-approved therapeutic options for treatment and control of anaplasmosis are currently available:

  • Treatment: A number of oxytetracycline injectable drug products are approved for the treatment of anaplasmosis. A summary of the approved use conditions for such products can be found in 21 CFR 522.1660a and 522.1662a.

  • Control: A number of applications for use of chlortetracycline (CTC) in Type C medicated feeds (including complete medicated feeds and several free-choice medicated feed formulations) are approved for control of active infection of anaplasmosis. A summary of the approved use conditions for such medicated feeds can be found at 21 CFR 558.128.

Note that chlortetracycline Type C medicated feeds are only approved for the control of active infection of anaplasmosis. Currently, such medicated feeds are not approved for the treatment or prevention of anaplasmosis. We encourage producers to work with their veterinarian if they are concerned that anaplasmosis is something they need to address in their herd health plan.
Information about specific approved animal drugs can be found in the FDA’s searchable database, Animal Drugs at FDA.

Where can feed manufacturers find information about the formulation of free-choice medicated feed?

The sponsor of an approved free-choice medicated feed could choose either to keep the formula proprietary or have it published. The FDA is allowed to post the Blue Bird labeling with the approved formulation for published formulas. Blue Bird labels are sponsor-provided labels that describe the conditions under which a drug or a drug combination is safe and effective and includes specific mixing or feeding directions. Accordingly, the FDA has posted two Blue Bird labels with the formulation for Type C Medicated Cattle Free-Choice Mineral Feed containing 6000 g/ton CTC. This labeling is for an approved free-choice salt-mineral mix containing CTC from one of two specific Type A medicated articles (either Aureomycin®, NADA 048-761 or Deracin®, ANADA 200-510) that are indicated for use in beef and non-lactating dairy cattle as an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to CTC. Publicly available formulations of CTC free-choice feed may be manufactured at any feed mill.

The FDA has also approved several proprietary (unpublished) formulations for the use of CTC in free-choice medicated feeds for control of anaplasmosis. Only the sponsors of proprietary formulations or the entities with access to them are able to manufacture such free-choice medicated feeds. Proprietary formulations may only be manufactured at a licensed feed mill (21 CFR 510.455(f)).

What does the term “hand-fed” mean on FDA-approved labels?

The term “hand-fed” refers to a feeding system in which a medicated feed is fed: (1) to groups of animals, (2) on a daily (24-hour period) basis, (3) for the approved duration of feeding, (4) in amounts that may (but do not necessarily) constitute the animals’ complete diet, which are intended to provide the entire approved daily drug dose over the course of the 24-hour period.

Production Scenario Example

Producer A wants to feed 2 pulses of Chlortetracycline (CTC) in the nursery phase (8 week duration of growth). In a single group of a 1,000 pigs, they get 2 weeks of CTC at the beginning (weeks 0-2 at 15 lbs. of weight) and again the last 2 weeks of the group (weeks 7-8 at 60 lbs. of weight). How many VFDs are required for this group?

A veterinarian cannot issue a VFD that authorizes a duration of use that is inconsistent with the directions for use described on the product labeling. In the example provided, if the approval limits the treatment to 14 days, the VFD can only authorize that approved duration. Issuing a VFD that authorizes a 14-day course to be repeated for the same animals would be considered an illegal extra-label use.

However, if the veterinarian reassesses the animals involved after a single course of therapy (i.e., drug administered according to the labeled dose and duration), the veterinarian may decide that additional therapy is warranted. In such case, a new VFD is needed.

What are the extralabel compliance guidelines for minor species?

Please refer to the following PDF and read carefully for compliance guidelines:  
Compliance Policy Guide Sec. 615.115: Extralabel Use of Medicated Feeds for Minor Species Guidance for FDA Staff

Who should I contact if I have additional questions?

If you have further questions, please contact our bureau.

Drug Residue Frequently Asked Questions
What are the major areas of focus when preventing illegal drug residues?

The four main areas that all parties involved in raising food-producing animals should be concerned with include proper drug use, recordkeeping, withdrawal times and AMDUCA/extralabel use regulations.

What information should I learn from medicated labeling?

All parties should pay attention to drug labels for proper drug usage by following specific instructions of specific medications for administration. Drug labels also provide important information about storage of medication(s); drug labels should be read and understood before giving any medication and if a drug is issued by a licensed veterinarian under a valid veterinary-client-patient relationship, the written use and instructions from the veterinarian should be followed. Also, no drug residues above permitted levels may be present in the final food product whenever a drug is used in an extralabel manner by a veterinarian.

What measures should my control systems include?

Persons involved in raising, handling, transporting, holding and marketing food-producing animals are encouraged to establish systems to ensure that animal drugs are used properly and to prevent potentially hazardous drug residues in edible animal products. To ensure safety, control measures should include the following steps:

  1. Identifying and tracking animals to which drugs were administered in order to preclude the sale of edible animal tissue, milk or eggs containing illegal residues (identification may be by specific animal identification, pen or lot, quarantine/segregation, or other means)

  2. Maintaining a system of medication/treatment records that, at a minimum, identifies the animal(s) treated (individual animals, pens, lots, etc.), the date(s) of treatment, the drug(s) administered, who administered the drug(s), the amount administered, and the withdrawal time prior to slaughter (and when milk, eggs, etc. can be used, if appropriate)

  3. Properly storing, labeling, and accounting of all drug products and medicated feeds

  4. Obtaining and using veterinary prescription drugs only through a licensed veterinarian based on a valid veterinarian/client/patient relationship

Educating all employees and family members involved in treating, hauling and selling of the animals on proper administration techniques, observance of withdrawal times and methods to avoid marketing adulterated products for human food.

Establishing and maintaining such systems should help producers avoid marketing milk, eggs or edible animal tissue containing illegal residues and avoid regulatory action based on Sections 402(a)(2)(D), 402(a)(4), or 501(a)(5).

What if I am the person that does not administer medications to food-producing animals and an illegal residue occurs?

Persons who do not administer medications but who purchase or lease animals for milking or sale for slaughter (such as livestock dealers) should also establish and implement a record-keeping system. This system should include information on the source of the animal and whether the animal has been medicated (when, with what drug, and the withdrawal period) to preclude marketing of edible animal tissue, milk or eggs that may contain illegal residues. Such persons may also be subject to regulatory action if they market animals containing illegal residues and have failed to take reasonable precautions to prevent the sale of adulterated food.

What are the FDA’s and CVM’s regulatory action guidance?

FDA investigators should determine the extent of the misuse of drugs in food-producing animals during the course of their inspections or investigations, such as when following up on an illegal tissue residue report from United States Department of Agriculture/Food Safety and Inspection Service or other information concerning improper drug use. The occurrence of an illegal tissue residue will be regarded as prima facie evidence of improper drug use, and may be an appropriate subject for enforcement action. Of course, before recommending such action, FDA will also consider whether evidence of proper drug usage exists to demonstrate that every reasonable effort has been made to preclude residues.

CVM is prepared to recommend regulatory action when drugs are misused as described above. If the misuse involves administration contrary to labeled directions, the drug itself is adulterated under Section 501(a)(5). If an illegal residue is involved, the food is adulterated under Section 402(a)(2)(D). Further, if an illegal residue is involved and inadequate control measures are documented, the food (edible animal tissue, milk, or eggs) may also be adulterated under Section 402(a)(4). Except in egregious situations, a warning letter is ordinarily the appropriate action of choice. Compliance Program 7371.006, Illegal Drug Residues in Meat and Poultry, provides additional regulatory guidance for illegal residues.

Drug residues in milk should be handled according to Compliance Programs 7318.003, Milk Safety Program and 7371.008, National Drug Residue Milk Monitoring Program.

Who should I contact if I have additional questions?

Further questions about these issues may be directed to AskCVM@fda.hhs.gov.