Veterinary Feed Directive FAQ – Client Topics

A client recipient of an animal feed containing a VFD drug or a combination VFD drug must:

• only feed animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) to animals based on a lawful VFD issued by a licensed veterinarian (21 CFR 558.6(a)(1));
• not feed a VFD feed or combination VFD feed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2));
• provide a copy of the VFD to the distributor when requested to do so by the issuing veterinarian (21 CFR 558.6(b)(8));
• maintain a copy of the VFD for a minimum of 2 years (21 CFR 558.6(a)(4)); and
• make the VFD available for inspection and copying by FDA upon request (21 CFR 558.6(a)(5

In order for a VFD to be lawful, the VFD must be issued and used in compliance with all applicable requirements in 21 CFR 558.6(a)1 and 21 CFR 558.6(b). One such requirement is that the veterinarian must issue the VFD in the context of a State-defined VCPR or, if the VCPR requirements as defined by such State do not include the key elements of the Federally-defined valid VCPR or are not applicable to the issuance of a VFD, then the veterinarian must issue the VFD in the context of a valid VCPR as that term is defined in FDA’s regulations at 21 CFR 530.3(i) (21 CFR 558.6(b)(1)(ii)). In cases where the Federally-defined VCPR applies, in order for the VFD to be written in the context of a valid VCPR you, as the client, must agree to follow instructions of the veterinarian (21 CFR 530.3(i)(1)). In cases where a veterinarian is issuing the VFD in the context of a State-defined VCPR, as a client you must follow the client requirements in the State-defined VCPR.

No, a veterinarian may only write a VFD to authorize use of a VFD drug or combination VFD drug in feed for the approved, conditionally approved, or indexed conditions of use (21 CFR 558.6(b)(2)). Use of VFD feed in an extralabel manner is prohibited (21 CFR 558.6(a)(3)). However, if you raise a minor species and there is no approved use for that species, see Question III.A.22. My client has minor species. I would like to write a VFD for a therapeutic use of a medicated feed, but there is not an approval for this species. What should I do?

No, a VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)). A client may use the VFD to obtain VFD feed any time prior to the VFD’s expiration, but the client may not feed that feed to animals after the VFD expires. For some drugs, there are discrete expiration and duration of use time periods specified as part of the drug approval which make it easier to determine in advance whether treatment would be completed by the VFD’s expiration date. The client is responsible for feeding the VFD feed in compliance with the terms of the VFD, which means completing the authorized course of treatment by the expiration date. If a VFD will expire prior to the completion of a course of treatment, the client must not feed the VFD feed to animals after the VFD’s expiration date. Animals cannot legally be fed the VFD feed after the VFD expiration date. The client could either discard the remaining VFD feed once the VFD expires or obtain a new VFD from the veterinarian to authorize use of the remaining feed for the full course of treatment before the new VFD expires.

In cases where a client would like to use a VFD feed but cannot complete the duration of use on the VFD before the VFD expires, the client should contact the veterinarian to request a new VFD. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)).

In general, only one distributor (e.g., feed mill) should receive and fill a VFD.

The VFD regulation requires a 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 (21 CFR 558.6(b)(8)).

When the veterinarian is issuing the VFD directly to the distributor (i.e., the client will not be taking a hardcopy to the distributor), the client should tell the veterinarian to which distributor the VFD should be sent. If the client is unsure of which distributor should receive the VFD, the client should get a hardcopy from the veterinarian to provide to the client’s distributor of choice. If the veterinarian has sent the VFD to a distributor and the client decides to get the VFD feed from a different distributor, the client should ask the veterinarian to revoke the VFD from the original distributor and resend it to the new distributor.

In special circumstances, such as when 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 distributors 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 situations where it has been predetermined that the VFD feed will come from two different distributors during the VFD’s duration of use, the veterinarian should indicate in the special instructions area of the VFD who the distributor of the VFD feed will be for each portion of the treatment period. Both distributors should receive copies of the VFD. Each distributor should provide only the amount of feed that is commensurate with the approximate number of animals and the portion of the treatment period for which the distributor is responsible for distributing the VFD feed.

Yes. The VFD does not include information about the nutritional ingredients in the ration of the VFD feed, so it is acceptable to feed several rations under a single VFD provided that each of those rations is manufactured in a way that is consistent with the drug approval and used in accordance with terms of the VFD.

A veterinarian cannot issue a VFD that authorizes a duration of use that is inconsistent with the directions for use described on the approved product labeling (21 CFR 558.6(b)(2)). In the example provided, the approval limits the treatment to 5 days and, therefore, the VFD can only authorize that approved duration. Issuing a VFD that authorizes a 5-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., after the drug was administered according to the labeled dose and duration), the veterinarian may decide that additional therapy is warranted. In such case, a new VFD would be needed.

The veterinarian should report to FDA any treatments that were not clinically effective or any adverse reactions that may have occurred within 10 days of their occurrence. For instructions on reporting such information, visit FDA’s webpage entitled “How to Report Animal Drug and Device Side Effects and Product Problems.”1

Yes, but the new owner may need to get a new VFD to continue treatment. In some situations, ownership of the animals changes but the animals continue to be fed by the same caretaker. Where this is the case, provided the caretaker is the client for the purposes of the VCPR requirements, the VFD would still be valid. However, if the ownership transfer results in a new client for the purposes of the VCPR, the new client would need a new VFD for the transferred animals. Only a veterinarian that has a VCPR with the new owner (i.e., the new client) and the transferred animals could write the new VFD (21 CFR 558.6(b)(1)(ii)).

In many situations, the transfer of ownership during a certain life stage of the animal may be expected. For example, oftentimes one owner may raise a group of animals to a certain age or weight and then sell that group to another owner who will continue to raise them. It is very important during a transfer of ownership that the veterinarians and clients are communicating and working together to avoid any unlawful use of the VFD feed.

For example, the veterinarian and original client should discuss the implications of a planned transfer of ownership at the time the veterinarian is issuing the VFD to ensure that the authorized course of treatment can be completed prior to the planned transfer of ownership. The original client should also make the new client (purchaser) aware of any VFD feed that already has been fed to the animals, including information about the indication, dosage, and duration of use.

To ensure the animals will receive a complete treatment, it is preferable not to transfer ownership during a time when VFD feed is being fed for a specific duration of use. If a transfer of ownership needs to be made while animals are being fed under a VFD, coordination between the original owner and veterinarian, and the new owner and veterinarian is important. The new veterinarian should issue a new VFD according to the approval but may use the special instructions area of the VFD to acknowledge the ownership transfer and record how much time remains to complete the treatment under the duration of use, taking into consideration how long the animals received treatment under the VFD held by the previous owner.

A VFD feed may be manufactured and shipped in one load or multiple loads. This provides flexibility for the VFD feed to be manufactured and distributed in a way that meets the nutritional needs of the animals, the manufacturing capacity of the feed distributor, and the storage capacity of the client. However, the amount of feed manufactured and distributed should be appropriate for the approximate number of animals authorized to be fed under the VFD and can only be used up to the VFD’s expiration date unless the client obtains another VFD authorizing the use of the remaining VFD feed (21 CFR 558.6(a)(2)).

Yes, you can get VFD feed from Canada. However, medicated feeds coming into the U.S. must comply with U.S. requirements. If the medicated feed is a VFD feed, it must comply with the requirements in the VFD regulation. This means, for example, that the veterinarian authorizing the use of the VFD feed must have a valid VCPR with the client and the client’s animals, and must be licensed in the State where the animals are being raised and fed (21 CFR 558.6(b)(1)). In addition, the medicated feeds must be manufactured and labeled in conformance with U.S. requirements – including being labeled for the U.S. market.

Yes, when the veterinarian selects an affirmation of intent statement that allows for the use of the VFD drug in combination with OTC drugs, either in a specific approved combination, or in any approved combination, the client may also use the VFD drug alone. In the preamble to the VFD proposed rule, after describing the three affirmation of intent options, we stated that “[i]n all cases, the VFD may be used to authorize the distribution and use of medicated feed containing the VFD drug alone” (78 FR 75515 at 75521, December 12, 2013).

Type A medicated articles for VFD drugs are not considered VFD feeds. Therefore, a VFD is not required to obtain a Type A medicated article from a distributor. However, the FD&C Act generally requires a VFD for the distribution and use of any VFD feed resulting from the Type A medicated article (section 504(a)(3) of the FD&C Act (21 U.S.C 354(a)(3))). Therefore, in general, you must have a VFD prior to distributing or using the VFD feed manufactured with the VFD Type A medicated article.

A medicated feed mill license is required if the VFD drug used to manufacture a Type B or Type C medicated feed is a Category II, Type A medicated article (21 CFR 558.4(a)). A list of Category II drugs is located at 21 CFR 558.4(d).

In addition, any person who is manufacturing, processing, packing, or holding medicated feed must do so in compliance with the applicable CGMP requirements for medicated feeds, which are found in 21 CFR part 225.

Three parties, the veterinarian, client, and the VFD feed distributor are required to keep the record of a VFD (21 CFR 558.6(a)(4)). However, in cases of on-farm milling, where a VFD feed distributor was not involved in the original transaction, only the veterinarian and the client would need to maintain copies of the VFD since there would not be a need for a VFD distributor copy.

Yes. If a client decides to source VFD feed from another distributor prior to the expiration date of the existing VFD, then:

• (1) the existing VFD will need to be cancelled with the current distributor as described in Question III.A.7. How do I cancel my VFD?, and
• (2) a new VFD will need to be issued and sent to the second distributor.

All parties, including the veterinarian, client, and the first distributor, should document the situation to explain why the cancellation occurred. The veterinarian authorizing the new VFD will need to consider any changes in the approximate number of animals left to be fed the VFD feed under the new distributor (21 CFR 558.6(b)(3)(viii)). Switching from one distributor to another after distribution of VFD feed is expected to be a rare occurrence.

Under the VFD regulation, clients are only required to keep a copy of the VFD itself (21 CFR 558.6(a)(4)). However, it may be important for clients, particularly those who raise foodproducing animals, to keep additional records to help ensure that the VFD feed was used in accordance with the VFD and any food made from the treated animals will be safe. For example, a client may want to record information such as the date the VFD feed was received, when the VFD feed was used, and which animals received the VFD feed to document that the VFD feed was fed in accordance with the VFD. While this documentation is not required by the VFD regulation, it would be helpful for a client to have such information available during an inspection to demonstrate whether a particular VFD was actually used and, if so, how the VFD feed was used.

In addition, where a VFD that has been issued to a client is subsequently cancelled, either at the client’s request or for other reasons, we recommend that the client keep records documenting the cancellation.

No, a client who keeps animals at multiple premises is not required to keep a copy of the VFD at each location where animals reside. It is acceptable for the VFD to be stored in one location; however, if the client is not directly feeding the animals at each location (e.g., an employee is feeding the animals), then the VFD should be made available to those responsible for the direct care of the animals so that they can feed the VFD feed in accordance with the VFD as required by the VFD regulation. This may be done by having a physical copy of the VFD at each location, or it may be done by providing electronic access to the VFD that is stored in a central location. Either way, the client is required to have a copy of the VFD (21 CFR 558.6(a)(4)). If an inspector requests a copy during an inspection at one location, the client (or their employee) must be in possession of the VFD or must have a way to readily access the VFD (21 CFR 558.6(a)(5)).

Disposal of the feed should be in a manner that is in accordance with State or local requirements for medicated feeds.

OTC drugs administered through drinking water will b transitioning to prescription (Rx) status; nothing in the VFD Final Rule changed how prescription drugs are regulated.

A VFD drug is not a prescription drug. If an internet pharmacy distributes VFD feed to another distributor or client, they would be considered a distributor and need to notify FDA and follow the distributor requirements.

The client’s name and address on the VFD should reflect the ‘client’ in the veterinarian-client-patient relationship. The client is the owner of the animal or animals or other caretaker (i.e., typically the person responsible for the oversight of feeding the animals). An FFA Advisor or 4-H leader could be considered the caretaker provided they are in fact assuming responsibility for the care and feeding of the animals.

A medicated feed mill license is required to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article (21 CFR 558.4(a)). A medicated feed mill license is also required to manufacture certain free-choice medicated feeds (21 CFR 510.455(f)) and liquid medicated feeds (21 CFR 558.5(g)). Thee licensing requirements are the same whether manufacturing medicated feed from OTC or VFD drugs.

Additional information on Medicated Feed Mill licensing can be found at:

http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/default.htm

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.

If the producer is not a distributor, they must have a VFD to receive a Type B or C VFD medicated feed.  If the producer is also a distributor (because they will ship feed to another person as defined in 21 CFR 558.3(b)(9)) they can provide either an acknowledgment letter or VFD to their distributor to receive a Type B or C VFD medicated feed.  

If the producer is obtaining a Type A medicated article that is not a VFD feed, the producer does not need to provide an acknowledgment letter or VFD to receive the Type A medicated article.  The producer will need a VFD prior to feeding any resulting Type C medicated feed that they mix from the Type A medicated article.

The statute states that “Any persons involved in the distribution or use of animal feed bearing or containing a veterinary feed directive drug and the licensed veterinarian issuing the veterinary feed directive shall maintain a copy of the veterinary feed directive applicable to each such feed, except in the case of a person distributing such feed to another person for further distribution. Such person distributing the feed shall maintain a written acknowledgment from the person to whom the feed is shipped stating that that person shall not ship or move such feed to an animal production facility without a veterinary feed directive or ship such feed to another person for further distribution unless that person has provided the same written acknowledgment to its immediate supplier.” (Section 504(a)(3) of the FD&C Act (21 USC 354(a)(3)).

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.

Some animal producers manufacture their own medicated feed directly from Type A articles. In this situation, the producer may purchase Type A medicated articles from a sponsor without the VFD, but the producer is required to have a VFD authorizing the use of a VFD feed to be fed to their animals prior to mixing any VFD feed. Some producers manufacture their own medicated feed from a Type B or C medicated feed. In these situations, the producer would need a VFD to obtain a Type B or C medicated feed from a distributor. (Section 504(a)(3) of the FD&C Act (21 U.S.C 354(a)(3))).

We recognize that for producers who manufacture their own medicated feed it may be important to maintain some Type A medicated articles or medicated feed in inventory to manufacture medicated feed quickly in order to provide animals with timely treatment after receiving VFD authorization from their veterinarian. However, the inventory should be appropriate to the expected amount of VFD feed that would be needed to treat that producer’s animals. As a reminder, any VFD feed must be fed under a valid VFD issued by a licensed veterinarian and the use of the VFD feed must be consistent with the conditions of use as set out in the VFD, including expiration dates.