Veterinary Feed Directive FAQ – Veterinary Topics

For a VFD to be lawful, the veterinarian issuing the VFD:

• Must be licensed to practice veterinary medicine (21 CFR 558.6(b)(1)(i));
• must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements (21 CFR 558.6(b)(1)(ii));
• must only write a VFD in the context of a valid VCPR (21 CFR 558.6(b)(1)(ii));
• must only issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug (21 CFR 558.6(b)(2));
• must prepare a written (nonverbal) VFD (21 CFR 558.6(b)(7)) that includes the veterinarian’s electronic or written signature (21 CFR 558.6(b)(3)(xv));
• must ensure the VFD includes all required information specified in the VFD regulation (21 CFR 558.6(b)(3));
• may enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed (21 CFR 558.6(b)(4));
• must include certain drug-specific information for each VFD drug when the veterinarian is authorizing the use of a drug combination that includes more than one VFD drug (21 CFR 558.6(b)(5));
• for VFD drugs approved for use alone or in combination with one or more OTC drugs, must include on the VFD an affirmation of intent either to restrict authorized use only to the VFD drug cited on the VFD or to allow the use of the cited VFD drug in an approved combination with one or more OTC drug(s) (21 CFR 558.6(b)(6));
• must provide the distributor with a copy of the VFD (21 CFR 558.6(b)(8));
• must provide the client with a copy of the VFD (21 CFR 558.6(b)(9));
• must retain the original VFD for 2 years (21 CFR 558.6(a)(4)); and
• must provide VFDs for inspection and copying by FDA upon request (21 CFR 558.6(a)(5)).

[Source: FDA GFI 120]

No, a veterinarian may only write a VFD for drugs that have been approved, conditionally approved, or indexed as VFD drugs by the FDA (21 U.S.C. 354). However, where the veterinarian is authorizing the use of a VFD drug approved for use in combination with one or more OTC drugs, the veterinarian must include an affirmation of their intent. (21 CFR 558.6 (b)(6)(iii)) [Source: FDA GFI 120]

Some VFD drugs are approved for use alone or in a combination with one or more OTC drug(s). In those circumstances, the issuing veterinarian would specify on the VFD whether he or she authorizes the VFD drug to be used alone or in an approved drug combination with one or more OTC drug(s). In accordance with 21 CFR 558.6(b)(6), the veterinarian is required to affirm his or her intent by including one of the following three statements on the VFD:

• “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.”
  • This statement is used if the veterinarian does not authorize the VFD drug to be used in combination with any other animal drug in the medicated feed. For those VFD drugs that are only approved as a single ingredient Type A medicated article, i.e., there are no approved combinations that contain the VFD drug as a component, this statement is the only one of the three statements that can be selected and it must be included in the VFD.
• “‘This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.’ [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.]”
  • This statement is used if the veterinarian chooses to authorize the use of the VFD drug(s) only in specific combination(s); the veterinarian may only list approved, conditionally approved, or indexed combination(s) that contain the VFD drug. The client is authorized to use the VFD drug(s) in medicated feed either alone or in those specific combinations that the veterinarian has specified on the VFD.
• “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDAapproved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.”
  • This statement is used if the veterinarian authorizes the use of the VFD drug(s) in any approved combination that contains the VFD drug. The client is authorized to use the VFD drug(s) either alone or in any approved, conditionally approved, or indexed combination with the OTC drug(s) in the medicated feed.

[Source: FDA GFI 120]

An EPA-registered feed through pesticide may be added to most medicated feeds, including VFD feed. However, adding a feed through pesticide to a liquid medicated feed or free-choice dry/liquid medicated feed would require a specific FDA approval (21 CFR 558.5(f)). Addition of a feed through pesticide to these types of feeds would affect the approved formula/specifications, which could affect the safety profile of the medicated feed by altering the drug intake and drug stability.

An EPA-registered feed through pesticide should not be added to a VFD feed if there is information suggesting that the addition of the EPA-registered feed through pesticide would interfere with the safety and/or efficacy of the VFD feed. In addition, feed through pesticides must be used according to their labeling and in compliance with EPA regulations, including the “Tolerances and Exemptions for Pesticide Chemical Residues in Food” requirements (40 CFR part 180).

You do not need to specify the inclusion of any feed through pesticide on the VFD. However, there is a location for the veterinarian to write any “special instructions” on the VFD (21 CFR 558.6(b)(3)(xi)). If the issuing veterinarian wants to recommend the inclusion of a feed through pesticide when authorizing the use of a VFD feed, this may be included in the special instructions area of the VFD.

[Source: FDA GFI 120]

The veterinarian may, at his or her discretion, more specifically identify the animals authorized to be treated/fed the VFD feed (21 CFR 558.6(b)(4)). Specifically, the veterinarian can further specify the location of the animals (e.g., site, pen, barn, stall, or tank), the approximate age or weight range of the animals, or any other information the veterinarian deems appropriate to identify the animals subject to the VFD. [Source: FDA GFI 120]

For an immediate delivery of an electronic VFD in this situation, we recommend that the veterinarian print a copy of the VFD and have it hand delivered, transmitted by facsimile, or scanned and transmitted electronically to the distributor. [Source: FDA GFI 120]

To cancel a paper VFD we recommend that the veterinarian promptly contact the client and distributor in possession of a copy of the VFD and notify them of the cancellation.

To cancel an electronic VFD that involves a third-party server, we recommend that the veterinarian contact the server and request that the VFD not be transmitted. If the veterinarian wants to cancel the VFD after the order has been electronically transmitted, we recommend that he or she contact the distributor and client who received a copy of the VFD and notify the distributor of the cancellation.

We recommend that all involved parties document the cancellation and be prepared to make all records available at the time of an inspection. We also recommend that all involved parties document the final outcome of the cancellation (e.g., state that the VFD feed was neither prepared nor distributed to the client, or the client did not receive or did not use any VFD feed).

If the veterinarian wishes to cancel a VFD, but some animals have already started consuming the VFD feed, the veterinarian should work with the client to ensure those animals complete consumption of the VFD feed in accordance with the VFD unless the veterinarian determines under their medical judgment that continuation of treatment would not be in the best interest of the animals’ health.

[Source: FDA GFI 120]

No, issuing VFDs electronically is optional. Paper VFDs remain an acceptable means of authorizing the use of a VFD drug. [Source: FDA GFI 120]

Although it is not mandatory for VFD drug sponsors to provide copies of VFD forms specific to their products for use by veterinarians, sponsors may make the VFD forms available to veterinarians. We recommend that sponsors make VFD forms available in triplicate or on a website to enhance efficiency and completeness of VFD transmissions. Regardless of whether or not a drug sponsor makes VFD forms available to veterinarians, a veterinarian may create a VFD form for a VFD drug. Any VFD form, whether provided by the drug sponsor or created by a veterinarian, must include the information specified in 21 CFR 558.6(b)(3). [Source: FDA GFI 120]

Although many companies distribute for use by veterinarians a VFD form that is specific to their products, a veterinarian may also create or use a different VFD form provided it contains all the required information specified in 21 CFR 558.6(b)(3). We have issued guidance on a common format for VFDs which may be useful if you choose to make your own VFD form. See Guidance for Industry #233, “Veterinary Feed Directive Common Format Questions and Answers.” [Source: FDA GFI 120]

Yes, VFD feed that was distributed under a VFD that has since expired can be used under a new VFD so long as that use is in conformance with the VFD drug’s approval and the VFD regulation. For example, the VFD feed may be used for another group of animals under a new VFD, so long as the VFD feed is consistent with the authorization on the new VFD (e.g., correct drug level). [Source: FDA GFI 120]

If you are a veterinarian and a distributor, to distribute medicated feed you would need to follow the distributor requirements, including sending a one-time notification to FDA that you are a distributor (21 CFR 558.6(c)). As a distributor, you would need to have on file either a VFD from a client or an acknowledgment letter, if the client is also a distributor. In addition, you would need to meet all the requirements related to being a distributor and distributing VFD feed found in 21 CFR 558.6. [Source: FDA GFI 120]

In order for a veterinarian to write a lawful VFD, the veterinarian issuing the VFD must: 1) be licensed to practice veterinary medicine; and 2) be operating within the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a valid VCPR as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in 21 CFR 530.3(i), the veterinarian must issue the VFD in the context of a valid VCPR as defined in 21 CFR 530.3(i) (21 CFR 558.6(b)(1)).

Refer to this link to determine if the State or Federal VCPR definition applies to a lawful VFD in your State: https://www.fda.gov/animal-veterinary/development-approval-process/does-state-orfederal-vcpr-definition-apply-lawful-vfd-my-state

A veterinarian would need to meet these requirements for the State in which the animals are located in order to issue a lawful VFD. This requirement is typically met by the veterinarian having a license to practice veterinary medicine in the State. However, in some States a veterinarian may be able to practice veterinary medicine within that State even if the veterinarian is licensed in another State, through reciprocity or a similar type of program.

Because under both Federal and State VCPR requirements, veterinarians must be available to provide any necessary follow-up evaluation or care (see 21 CFR 530.3(i)), veterinarians cannot write a lawful VFD under a valid VCPR if they do not have permission to practice veterinary medicine for those animals during the entire duration of the VFD. Therefore, the expiration date of the VFD should not exceed the length of time during which the veterinarian is temporarily authorized to practice veterinary medicine in the State where the animals are located.

[Source: FDA GFI 120]

No, the client cannot decide when to stop feeding a VFD feed when you authorize the VFD for the full 42 days. The VFD authorizes the use of the VFD feed as required by 21 CFR 558.6(a)(1). Therefore, the use of the VFD feed must conform to the information the veterinarian authorizes on the VFD.

In situations where there is a range for the VFD, the veterinarian should use his or her medical judgment to determine an appropriate duration. It is acceptable for the veterinarian to indicate the approved range for the duration and then provide additional information in the “special instructions” area of the VFD, including when it is appropriate to discontinue treatment. Using the example provided, the veterinarian could write 21-42 days in the duration and write in the special instructions area “Feeding may be discontinued after 21 days but prior to 42 days when no symptoms have been observed for [X] days.”

[Source: FDA GFI 120]

Because the VFD regulation requires the veterinarian to write “the level of VFD drug in the VFD feed and duration of use” on the VFD (§ 558.6(b)(3)(x)), the VFD must specify the drug(s) in terms of its level in the feed (e.g., expressed in g/ton). In most instances, the allowable level(s) of a VFD drug in feed is provided in g/ton as part of the approved labeling (including Blue Bird labels) for the VFD drug. However, in situations where the VFD drug labeling (including Blue Bird labels) expresses drug level in feed in a manner other than “g/ton” (e.g., mg/lb feed, %, ppm), the VFD may be prepared using either the units reflected on the VFD drug labeling or in terms of its level in the feed (e.g., in g/ton).

In some instances, the allowable level(s) of a VFD drug in feed (e.g., expressed in g/ton) is not provided as part of the approved labeling (including Blue Bird labels) for the VFD drug. In such circumstances, an appropriate level of the drug for the feeding situation needs to be determined by the authorizing veterinarian. The approved Blue Bird labels often provide examples (e.g., based on a range of potential feed intake levels) that illustrate reasonable and appropriate drug levels in feed and may be useful to the veterinarian in determining what level of VFD drug in the feed is appropriate for the feed in question.

Many non-FDA resources are available to assist veterinarians in calculating the level of the VFD drug in feed that provides the approved dosage (e.g., X mg/head/day). The veterinarian may also need to work with the distributor and/or client to determine an appropriate level of VFD drug in the VFD feed. The distributor and client may have additional information, such as the consumption rate, which may be necessary to determine an appropriate drug level that is consistent with the approval.

[Source: FDA GFI 120]

Yes, a veterinarian may instruct a client to hold animals beyond the labeled withdrawal period for VFD drugs used in those animals. The labeled withdrawal period is a minimum that needs to be met. Therefore, it would be acceptable for a veterinarian to recommend an extended withdrawal period beyond the minimum required by the label if he or she deems it necessary.

For purposes of writing a lawful VFD, the VFD rule requires the withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval be written on the VFD (21 CFR 558.6(b)(3)(xi)). Therefore, the withdrawal period that the veterinarian writes on the VFD must be the withdrawal period that appears on the approved labeling for the use being authorized. However, the veterinarian may use the special instructions area of the VFD to provide the client with instructions for holding the animals for a longer time than the minimum required by the label to help ensure that any food from these animals is not adulterated.

[Source: FDA GFI 120]

Yes, a veterinarian may consult with others when preparing the VFD. As stated in the VFD regulation, the veterinarian is responsible for ensuring the VFD is complete and in accordance with the conditions for use in the relevant approval, conditional approval, or index listing (558.6(b)(2) and (3)). While we encourage veterinarians to work together with the client, feed distributor, nutritionist, or other animal health professionals to gather the information necessary to write a complete and accurate VFD, it is ultimately the veterinarian’s responsibility to issue the VFD and ensure that it is complete and in accordance with the approval, conditional approval, or index listing. [Source: FDA GFI 120]

Yes. The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed manufactured according to the VFD at the specified premises by the expiration date of the VFD.

The approximate number of animals should include all animals that are being authorized for treatment from the current and successive groups of animals on the premises prior to the expiration date. The treatment of any animals with VFD feed after the expiration date would need to be authorized under a new VFD.

[Source: FDA GFI 120]

Durations of use may be reflected in different ways in the approval, conditional approval, or index listing and on the corresponding labeling. Some labels do not allow the veterinarian any discretion in selecting a duration of use. For example, a label that states “feed for X days” indicates that the VFD feed must be fed for the exact number of days specified on the label and does not provide discretion for the veterinarian to authorize use for a different number of days.

In contrast, some labels do allow the veterinarian some discretion in selecting a duration of use. For example, a label that states “feed up to X days” indicates that the veterinarian has some discretion in selecting any number of days up to day X when writing the duration of use on the VFD. The client is authorized to use (feed) the medicated feed in compliance with the terms of a lawful VFD that is issued by a licensed veterinarian, so when discretion is allowed, it is important that the veterinarian writes the VFD to reflect how long the client should feed the animals the VFD feed.

[Source: FDA GFI 120]

The veterinarian is required to issue a VFD that is in compliance with the approved, conditionally approved, or indexed conditions for use (21 CFR 558.6(b)(2)). Therefore, the VFD must contain the information in the approval, which is the information for the Type C medicated feed that will be fed to the authorized animals.

However, this does not mean that the VFD must be filled with a Type C medicated feed. A VFD authorizes a client to receive a Type B or Type C medicated feed. If a client receives a Type B medicated feed, the client must follow the appropriate mixing directions so that the resulting Type C medicated feed conforms to the VFD drug approval and the VFD authorizing the use of the VFD feed (21 CFR 558.6(a)(3)). FDA’s “Blue Bird Labels” website has representative labeling with mixing instructions for Type B medicated feeds.

[Source: FDA GFI 120]

Extralabel use of drugs, including VFD drugs, in or on animal feed is prohibited (21 U.S.C. 360b(a)(4); 21 CFR 530.11(b)). However, we recognize that there are limited approved, conditionally approved, or indexed drugs for use in or on animal feed available for minor species. In addition, some minor species cannot be practically medicated in any other way than through the use of medicated feed. Compliance Policy Guide (CPG) Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species provides direction to field investigators with respect to factors to consider when determining whether to take enforcement action for the extralabel use of medicated feeds in minor species. The CPG provides guidance to FDA field personnel regarding the extralabel use of both OTC and VFD drugs in medicated feed for minor species.

As detailed among other considerations in the CPG, when authorizing the extralabel use of a medicated feed (including a VFD feed) for a minor species, a veterinarian should issue a written recommendation to the client and include the following statement in the “special instructions” area of the VFD order: “This VFD is being issued in accordance with CPG 615.115.”

[Source: FDA GFI 120]

No, there is not a requirement in the VFD regulations for laboratory analysis to confirm a diagnosis. It is up to the veterinarian authorizing the VFD to determine the level of clinical and diagnostic evidence necessary to authorize the VFD. [Source: FDA GFI 120]

Yes, under certain circumstances. For paper VFDs, the veterinarian can make changes to the original VFD at the time it is created by initialing and dating the corrections in ink or another indelible (i.e., permanent) method provided that the original information is not obscured. Please note that we expect only minor edits (e.g., correcting the address, the expiration date, etc.) could be made without needing reissue a new VFD. For electronic VFDs, simply correct the error electronically prior to issuing the VFD. A new VFD would be recommended if these conditions cannot be met.

If the VFD has already been issued (i.e., the copies have already been sent to the client and/or distributor), we recommend you cancel the original incorrect paper or electronic VFD and issue a new, corrected VFD. If you plan to cancel the incorrect VFD, you should promptly contact the client and distributor in possession of a copy of the VFD and notify them of the cancellation.

[Source: FDA GFI 120]

Although you cannot complete the VFD ahead of time and date it with a future date, there are other ways that you can transition animals to a new VFD upon an old VFD’s expiration. 21 CFR 558.6 includes, among other things, the requirement that a VFD contain the veterinarian’s signature, the date of VFD issuance, and the VFD’s expiration date. The date the veterinarian signs the VFD is the date of VFD issuance, and the date of issuance is the basis for determining the date of expiration.

There are two ways under 21 CFR 558.6 to transition animals from a VFD that is expiring to a new VFD. Under the first option, you would issue a new VFD and at the same time cancel the existing VFD.   Under the second option, you would use the special instructions area of the new VFD to authorize the transition of the animals from the old VFD to the new VFD (21 CFR 558.6(b)(3)(xi)). To do this, you would issue a new VFD prior to the expiration (e.g., up to 2 weeks) of the old VFD and use the special instructions area to authorize feeding immediately after expiration of the existing VFD. We recommend that, whichever option you choose to use, you coordinate the timing with your client to ensure there are no interruptions in treating the animals. 

Here is an example of how the second option described above (i.e., the use of “special instructions”) would work in practice. You have previously issued a VFD that expires on September 14, but you have a planned visit to the farm on September 1. At your visit on September 1, you issue a new VFD and note in the special instructions area of the new VFD that it is effective on September 15, immediately after the former/old VFD has expired.  The former/old VFD will continue to authorize feeding the animals the VFD feed until September 14, and then, starting September 15, the new VFD will go into effect. Please note that the date of issuance for the new VFD will still be September 1, so if the VFD is issued for 6 months, the expiration date will be March 1 of the following calendar year.

[Source: FDA GFI 120]

Electronic records, such as an electronic VFD that meets the requirements of part 11, may be used in lieu of a paper VFD. As we have previously stated in GFI #120, part 11 applies to records in electronic form that are created, modified, maintained archived, retrieved, or transmitted under any FDA records requirements. Electronic VFDs issued by veterinarians must be compliant with part 11, and VFDs received electronically stored by distributors and clients must be compliant with part 11. 21 CFR part 11 does not apply to paper records that are, or have been, transmitted by electronic means (such as facsimile, email attachments, etc.).

The VFD is required to be signed by the veterinarian. If the veterinarian chooses to sign the VFD electronically, the electronic signature needs to be part 11 compliant. We recommend that users check with Global Vet Link, or any other electronic VFD service provider to confirm that the software system is part 11 compliant. If a veterinarian signs a paper copy and scans the VFD to distribute a copy to the client/distributor, that is not considered an electronic signature.

Additional information about part 11 compliance, including information on how FDA intends to exercise enforcement discretion with regard to certain part 11 requirements during the reexamination of part 11, can be found in GFI Part 11, Electronic Records; Electronic Signatures–Scope and Application; http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf

In order for a technical services veterinarian for a drug company to write a lawful VFD, the veterinarian issuing the VFD must 1) be licensed to practice veterinary medicine, and 2) be operating within the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in 21 CFR 530.3(i), the veterinarian must issue the VFD in the context of a valid VCPR as defined in 21 CFR 530.3(i) (21 CFR 558.6(b)(1)).

Refer to the link below to determine if the State or Federal VCPR Definition applies to a Lawful VFD in your State: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm

The VFD regulation requires the veterinarian to send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electronically. If in hardcopy the veterinarian must send the copy of the VFD to the distributor either directly or through the client. (558.6(b)(8)).

The distributor that the veterinarian or client gives the VFD to should be the only distributor filling the entire order. In special circumstances (eg., if a mill runs out of a VFD drug and the client needs VFD feed immediately to adhere to the treatment regimen or if a feed mill goes down unexpectedly), there may be a need for two mills to fill the entire order. If that is the case the client and distributors should all keep records documenting the situation so that it is clear that the animals received only the treatment authorized by the VFD.

In order for a small animal veterinarian to write a lawful VFD, the veterinarian issuing the VFD must 1) be licensed to practice veterinary medicine, and 2) be operating within the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in 21 CFR 530.3(i), the veterinarian must issue the VFD in the context of a valid VCPR as defined in 21 CFR 530.3(i) (21 CFR 558.6(b)(1)).

Refer to the link below to determine if the State or Federal VCPR Definition applies to a Lawful VFD in your State: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm

A National Veterinary Accreditation is not required for a veterinarian to issue a valid VFD. In order for a small animal veterinarian to write a lawful VFD, the veterinarian issuing the VFD must 1) be licensed to practice veterinary medicine, and 2) be operating within the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in 21 CFR 530.3(i), the veterinarian must issue the VFD in the context of a valid VCPR as defined in 21 CFR 530.3(i) (21 CFR 558.6(b)(1)).

Refer to the link below to determine if the State or Federal VCPR Definition applies to a Lawful VFD in your State: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm

The VFD regulation requires the veterinarian to send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electronically. If in hardcopy the veterinarian must send the copy of the VFD to the distributor either directly or through the client. (558.6(b)(8)). If the veterinarian provides the client with a hardcopy to take to the distributor, the client can go to the distributor of their choice.

When the veterinarian is issuing the VFD directly to the distributor (i.e., the client won’t be taking a hardcopy to the distributor), the client should tell the veterinarian which distributor to send the VFD to. If the client is unsure of where they would like to get the VFD feed, they should get a hardcopy from the veterinarian so they can provide it to the distributor of their choice. If the veterinarian has sent the VFD to a distributor and the client decides they would like to get the VFD feed from a different distributor, they should contact the veterinarian to have them revoke the VFD from the original distributor and resend it to the new distributor.

The veterinarian may write a VFD that covers animals in multiple locations (animal production facilities) to be fed the VFD feed by the expiration date on the VFD, provided he or she can do so in compliance with professional licensing and practice standards and provided the VFD feed is supplied to such multiple locations by a single feed manufacturer (distributor). The veterinarian would also need to be authorizing the same use for all of the animals covered under the VFD (e.g., the indications, species, age range, etc.).

The federal VCPR definition states in part that “Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animals and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.” 21 CFR 530.3(i)(3) In addition, one of the key elements required in order for a state VCPR to be recognized is that the veterinarian “have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed.” Therefore, for the purposes of issuing a VFD a VCPR cannot be established by video/photos.

21 CFR 558.6 identifies the three parties — veterinarian, producer and the VFD feed distributor, as the parties that are required to keep the record of a VFD order. If one firm represents the veterinarian, the distributor, and the client, it is acceptable for the VFD to be stored in one location provided that everyone required to have a copy has access and can provide a copy to the FDA investigator upon request.

A copy of the VFD does not need to be provided to FDA at the time of issuance, a copy of the VFD would only need to be provided to the FDA upon request.

The final rule requires the veterinarian to write in the “The level of VFD drug in the VFD feed and duration of use” (558.6(b)(3)(x)). The allowable level of drug in the VFD feed is part of the VFD drug approval and is located on the VFD drug label. Many non-FDA resources are available to assist veterinarians in making any needed calculations.

Because the VCPR requirements for both the federal VCPR and state VCPR must include the ability for the veterinarian to provide for any necessary follow-up evaluation or care the veterinarian cannot write a lawful VFD under a valid VCPR if they do not have permission to practice veterinary medicine for those animals during the entire duration of the VFD. Therefore, the expiration date of the VFD should not exceed the length of time the veterinarian is authorized to temporarily practice veterinary medicine.

21 CFR 558.6 identifies the three parties – veterinarian, producer (client), and the VFD feed distributor, as the parties that are required to keep the record of a VFD order.

In the situation described, for the purposes of the VCPR (veterinarian-client-patient relationship) and VFD it may be that the caretaker will be considered the client because it appears that is the person who is responsible for feeding the animals the VFD feed.

The preamble to the final rule and the definition for a veterinary feed directive describe the client as the “owner of the animals or other caretaker.” Response 26 in the preamble states that the “client name and address should reflect the client in the veterinarian-client-patient relationship, which is typically the person responsible for feeding the animals the VFD feed.”

The distributor that the veterinarian or client gives the VFD to should be the only distributor filling the entire order.

In special circumstances (e.g., if a mill runs out of a VFD drug and the client needs VFD feed immediately to adhere to the treatment regimen or if a feed mill goes down unexpectedly), there may be a need for two mills to fill the entire order. If that is the case, the client and distributors should all keep records documenting the situation so that it is clear that the animals received only the treatment authorized by the VFD.

It is unclear from the question whether the different feedmills are different locations for one distributor, as multiple feedmill locations could be considered one distributor if owned by the same corporation. A distributor is defined as “any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD.” (21 CFR 558.3(b)(9)). A person is defined in 201(e) of the FD&C Act “The term “person” includes individual, partnership, corporation, and association.” (21 USC 321(3)). One distributor may have multiple locations and it is acceptable for that distributor to fill a VFD from any of its locations.

In the preamble to the final rule we discussed how VFDs may be written for groups of animals with a similar age, weight range, etc., that are managed in a similar manner but housed at multiple premises. In the preamble, we said “the veterinarian may write a VFD that covers animals in multiple locations (animal production facilities) to be fed the VFD feed by the expiration date on the VFD, provided he or she can do so in compliance with professional licensing and practice standards and provided the VFD feed is supplied to such multiple locations by a single feed manufacturer (distributor).” The same principle would apply to groups of animals housed at the same facility, but receiving feed from separate mills. We would expect a separate VFD for the VFD feed received from each mill.

The VFD regulation requires the veterinarian to send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electronically. If in hardcopy the veterinarian must send the copy of the VFD to the distributor either directly or through the client. (558.6(b)(8)). The distributor that the veterinarian or client gives the VFD to should be the only distributor filling the entire order.

In special circumstances (e.g., if a mill runs out of a VFD drug and the client needs VFD feed immediately to adhere to the treatment regimen), there may be a need for two mills to fill the entire order. If that is the case the client and distributors should all keep records documenting the situation so that it is clear that the animals received only the treatment authorized by the VFD.

If the veterinarian provides the client with a hardcopy to take to the distributor, the client can go to the distributor of their choice. When the veterinarian is issuing the VFD directly to the distributor (i.e., the client won’t be taking a hard copy to the distributor), the client should tell the veterinarian which distributor to send the VFD to. If the client is unsure of where they would like to get the VFD feed, they should get a hard copy from the veterinarian so they can provide it to the distributor of their choice. If the veterinarian has sent the VFD to a distributor and the client decides they would like to get the VFD feed from a different distributor, they should contact the veterinarian to have them revoke the VFD from the original distributor and resend it to the new distributor.

Can two mills be put on the same VFD? The VFD includes information about the drug as approved for the indication. The VFD does not include information about the nutritional ingredients in the ration of the VFD feed. It is acceptable to feed several rations under a single VFD so long as each of those rations is consistent with the VFD and the drug approval.

Electronic VFD (e-VFD) orders issued by veterinarians may be stored either electronically or in hard copy by distributors and clients (see 21 CFR 558.6(a)(4)).

Although the electronic storage of e-VFD orders by distributors and clients must be compliant with 21 CFR Part 11, FDA has published its intent to exercise enforcement discretion with regard to certain Part 11 requirements in guidance the Agency issued in August 2003 entitled, “Part 11, Electronic Records; Electronic Signatures—Scope and Application.” The record retention portion of this guidance indicates that the Agency intends to exercise enforcement discretion with regard to the Part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period (§ 11.10 (c) and any corresponding requirement in §11.30). The guidance also states with respect to records retention that FDA does not intend to object if you decide to archive required records in electronic format to a standard electronic file format (examples of such formats include, but are not limited to, PDF, XML, or SGML).

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 authorized a 14 day course to be repeated for the same animals would be considered an illegal extralabel 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.

The distributor that the veterinarian or client gives the VFD to should be the only distributor filling the entire order. 

In special circumstances (e.g., if a mill runs out of a VFD drug and the client needs VFD feed immediately to adhere to the treatment regimen or if a feed mill goes down unexpectedly), there may be a need for two mills to fill the entire order.  If that is the case, the client and distributors should all keep records documenting the situation so that it is clear that the animals received only the treatment authorized by the VFD.

It is unclear from the question whether the different feedmills are different locations for one distributor, as multiple feedmill locations could be considered one distributor if owned by the same corporation.  A distributor is defined as “any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD.”  (21 CFR 558.3(b)(9)).  A person is defined in 201(e) of the FD&C Act “The term “person” includes individual, partnership, corporation, and association.”  (21 USC 321(3)).  One distributor may have multiple locations and it is acceptable for that distributor to fill a VFD from any of its locations. 

However, it is the distributor’s responsibility to comply with the applicable requirements in 21 CFR 558.6(a) and (c), including the requirement to distribute a VFD only if it complies with the terms of the VFD and the requirement to keep records of receipt and distribution of all VFD feed for 2 years.  Therefore, we would expect a distributor filling a VFD from multiple locations would have  required manufacturing records under 21 CFR 225 and VFD distribution records  under 21 CFR 558.6(c) that support that these requirements have been met. 

During an inspection we will review VFD orders and compare them to manufacturing records.  We would expect that the amount of medicated feed produced to fill that VFD, whether in one or several batches would be commensurate with the amount of feed necessary for the approximate number of animals the VFD authorizes to be fed.

A veterinarian must include the approximate number of animals that need to be treated on the VFD.  The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the specified premises by the expiration date of the VFD.  This number can include animals that are expected to be acquired by the client as part of the normal animal production operation prior to the expiration date of the VFD.  CVM expects that the veterinarian issuing the VFD will have knowledge of the capacity and normal animal turnover of the facility and the prevalence of illnesses when issuing a VFD that would include animals that the client will acquire during the time the VFD is valid.  This provision is not meant to allow the retreatment of animals.

In order for a veterinarian to write a lawful VFD, the veterinarian issuing the VFD must 1) be licensed to practice veterinary medicine, and 2) be operating within the course of the veterinarians professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter  (21 CFR 558.6(b)(1)).

Refer to this link to determine if the State or Federal VCPR Definition applies to a Lawful VFD in your State: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm

A veterinarian would need to meet these requirements for all of the animal locations in order to issue a lawful VFD. 

A veterinarian must include the approximate number of animals that need to be treated on the VFD. The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the specified premises by the expiration date of the VFD. This number can include animals that are expected to be acquired by the client as part of the normal animal production operation prior to the expiration date of the VFD.

CVM expects that the veterinarian issuing the VFD will have knowledge of the capacity and normal animal turnover of the facility and the prevalence of illnesses when issuing a VFD that would include animals that the client will acquire during the time the VFD is valid. This provision is not meant to allow the retreatment of animals.​

During an inspection we will review VFD orders and compare them to manufacturing records. We would expect that the amount of medicated feed produced to fill that VFD, whether in one or several batches would be commensurate with the amount of feed necessary for the approximate number of animals the VFD authorizes to be fed.

If you are the veterinarian and the distributor of a Type B or C VFD feed, to distribute the VFD feed you would need to follow the distributor requirements including sending a one-time notification to FDA that you are a distributor.  If you are distributing VFD feed (Type B or C) to another distributor you need to receive either a VFD or acknowledgment letter from that distributor. If you are distributing VFD feed (Type B or C) to a client then you need to receive a VFD from the client.

If you are distributing Type A medicated article, that is not a VFD feed and you do not need to receive an acknowledgment letter or VFD prior to distribution.

All involved parties (veterinarian, client, distributor) must retain a copy of the VFD order for 2 years. The veterinarian is required to keep the VFD order in its original format. The distributor and client copies may be kept as an electronic copy or hardcopy. If you are both the veterinarian and the distributor, keeping the original is sufficient.​