Veterinary Feed Directive FAQ – Distributor/Feed Mill Topics

The term “distributor” means 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)). As defined in the FD&C Act, the term “person” includes an individual, partnership, corporation, and association (section 201(e) of the FD&C Act (21 USC 321(e)).

If you are a feed mill or another person who meets the definition of “distributor” in 21 CFR 558.3(b)(9), you will be responsible for complying with the requirements applicable to distributors of VFD feed found in sections 558.6(a) and (c) of FDA’s VFD regulations (21 CFR 558.6(a) and (c)), which are discussed below.

If you distribute an animal feed containing a VFD drug or a combination VFD drug, you must:

• file a one-time notice with FDA of intent to distribute animal feed containing a VFD drug (21 CFR 558.6(c)(5)). The notice should be sent to the Food and Drug Administration, Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), 12225 Wilkins Ave., Rockville, MD 20852, Fax: 240-453-6882, or email (via attachment): MedicatedFeedsTeamMail@fda.hhs.gov (21 CFR 558.6(c)(7));
• notify FDA within 30 days of any change in ownership, business name, or business address (558.6(c)(6));
• fill a VFD only if the VFD contains all required information (21 CFR 558.6(c)(1));
• ensure that the distributed animal feed containing the VFD drug or combination VFD drug complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug (21 CFR 558.6(c)(2));
• ensure all labeling and advertising prominently and conspicuously displays the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.” (21 CFR 558.6(a)(6));
• retain VFDs for 2 years from date of issuance (21 CFR 558.6(a)(4));
• retain records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years (21 CFR 558.6(c)(3));
• provide VFDs for inspection and copying by FDA upon request (21CFR 558.6(a)(5));
• if you manufacture animal feed bearing or containing a VFD drug, retain records of VFD manufacturing for 1 year in accordance with 21 CFR part 225 and make such records available for inspection and copying by FDA upon request (21 CFR 558.6(c)(4)); and
• if you are an originating distributor (consignor) distributing feed to another distributor, you must obtain an acknowledgement letter from the receiving distributor (consignee) before the feed is shipped (21 CFR 558.6(c)(8)); and
• if you are a consignor distributor, you are required to retain a copy of each consignee distributor’s acknowledgement letter for 2 years (21 CFR 558.6(c)(8)).

A distributor must submit a one-time notification to FDA of intent to distribute medicated feed containing a VFD drug (21 CFR 558.6(c)(5)). The distributor notification must include the distributor’s complete name and business address, the distributor’s signature or the signature of the distributor’s authorized agent, and the date the notification was signed (21 CFR 558.6(c)(5)).

In some cases, a client (e.g., a producer) may also be a distributor. For example, when a manufacturer of a Type B VFD feed distributes the Type B VFD feed to a client, the client may manufacture a Type C VFD feed to either feed the VFD feed to his or her own animals and/or further distribute the Type C VFD feed to another distributor or client-recipient.

If the VFD feed is being shipped to a client who is a distributor that has previously sent a onetime notification to FDA, the client must supply either an acknowledgment letter or a VFD for the receipt of the Type B VFD feed from the distributor (if the client plans to use the feed for his or her own animals) (21 CFR 558.6(c)(2) and (8). (Note: In order for the client to receive a Type B or Type C VFD feed without a VFD in hand, he or she must have previously notified FDA that he or she is a distributor in accordance with 21 CFR 558.6(c)(5). If the client provides an acknowledgment letter to the distributor from whom the client receives the VFD feed, the client must either receive an acknowledgment letter or a VFD prior to further distributing the VFD feed to another person, or have a VFD on hand prior to feeding the Type C VFD feed to his or her own animals (21 CFR 558.6(c)(2) and (8)).

An updated notification is required to be sent within 30 days of any change in ownership, business name, or business address (21 CFR 558.6(c)(6)).

Yes, there are publicly available VFD distributor notifications lists. The lists are available at: Animal Drugs @ FDA, under the Medicated Feeds section. Lists are available in PDF and Excel spreadsheet formats.

An “acknowledgement letter” is defined in FDA’s regulations as “a written (nonverbal) communication provided to a distributor (consignor) from another distributor (consignee). An acknowledgement letter must be provided either in hardcopy or through electronic media and must affirm: (i) that the distributor will not ship such VFD feed to an animal production facility that does not have a VFD, (ii) that the distributor will not ship such VFD feed to another distributor without receiving a similar written acknowledgment letter, and (iii) that the distributor has complied with the distributor notification requirements of § 558.6(c)(5)” (21 CFR 558.3(b)(11)).

A distributor notification is the one-time notice by a distributor to the FDA of its intent to distribute a medicated feed containing a VFD drug (21 CFR 558.6(c)(5)).

The acknowledgment letter is a tool used when a distributor is distributing VFD feed to another distributor, instead of to a client. The distributor that is sending the VFD feed, also known as the consignor, gets the acknowledgment letter from the distributor receiving the VFD feed, also known as the consignee. The acknowledgment letter allows a distributor to have VFD feed on hand so that when a client provides a valid VFD, the distributor can promptly fill the VFD.

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 list of Category II drugs is located in 21 CFR 558.4(d). 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)). The licensing requirements are the same whether manufacturing medicated feed from OTC or VFD drugs (see 21 CFR part 515).

It depends. 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 license is not required if the VFD drug is Category I with the exception of certain liquid and free-choice medicated feeds (21 CFR 510.455(f), 558.5(g)). A list of Category II drugs is located in 21 CFR 558.4(d).

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 the required information, the distributor must not fill the VFD and we recommend that the distributor notify the veterinarian that the order cannot be filled until all the necessary information is provided on the VFD.

No, a VFD can only be used to authorize the use of a VFD drug that has been approved, conditionally approved, or indexed, either alone or in an approved combination VFD drug(s), which may in some cases include one or more OTC animal drugs in addition to the VFD drug(s) (21 CFR 558.6(a)(3)). If a distributor receives a VFD that specifies a drug or use other than an approved, conditionally approved, or indexed VFD drug(s), combination VFD drug(s), , the distributor may not fill that VFD (21 CFR 558.6(c)(2)).

A distributor is defined in the VFD regulations at 21 CFR 558.3(b)(9) as a person who distributes medicated feed containing a VFD drug to another person who is either the client or another distributor. Therefore, in the situation described, whether you are considered a distributor or not depends on whether the same person (individual or business entity) distributing the VFD feed is also acting as the client in the context of the VCPR under which the VFD has been authorized. If the same person is doing both activities, then the person is not distributing VFD feed to “another person” and is not a distributor. If different people are doing these activities, then the person distributing the VFD feed is distributing VFD feed to “another person” and is, therefore, a distributor within the meaning of 21 CFR 558.3(b)(9).

The question states that the animals are raised by the contract grower. So, it appears that the contract grower is the person who is responsible for feeding the animals the VFD feed and, therefore, would likely be considered the “client” for the purposes of the VCPR requirements for a valid VFD.

If the contract grower is the “client” as reflected on the VFD, the feed mill would then be distributing VFD feed to another person, and, therefore, would be considered a “distributor.” In such cases, the person providing the feed to the contract grower would need to meet the distributor requirements as described in 21 CFR 558.6 (e.g., provide one-time notification to FDA).

If the contract grower is not considered the client and instead the feed mill/animal owner is the “client” for the purposes of the VCPR requirements, the feed mill/animal owner would not be distributing a VFD feed to “another person” and thus would not be considered a distributor under 21 CFR 558.3. However, it is important to note that the client would need to have a lawful VFD in hand prior to feeding the VFD feed to the client’s animals.

Yes, the distributor may distribute a VFD feed to a representative of the client. We recommend that if a distributor has questions about whether a person is a representative of a client, he or she should contact the client directly to verify the relationship.

Yes, an acknowledgment letter can be written to cover multiple shipments and there are several ways to do so. One way is to write an acknowledgment letter to cover specific shipments of VFD feed within a specified time period. Another way is to write an acknowledgment letter to cover multiple shipments of VFD feed with an open-ended time period.

The acknowledgment letter must be kept for 2 years (21 CFR 558.6(c)(8)). If the acknowledgment letter has a specified time period, the acknowledgment letter must be kept for 2 years from the specified end date. If the acknowledgment letter is open-ended, the acknowledgment letter must be kept for 2 years from the date the last shipment was distributed under the acknowledgment letter.

Your responsibilities as the VFD manufacturer, and the dealer’s responsibilities, will depend on the activities each of you is performing in a given scenario. Specifically:

Scenario A – I manufacture feed and ship it to a dealer who intends to distribute it further:

In this scenario, you are considered a distributor because you meet the definition of distributor in 21 CFR 558.3(b)(9), which states, “For the purposes of this part, a ‘distributor’ means 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.” As a distributor, you must send a one-time distributor notification to FDA and follow the other distributor requirements in 21 CFR 558.6, including keeping a copy of any VFDs you receive for 2 years, records of the receipt and distribution of all medicated animal feed containing a VFD drug, and keeping VFD feed manufacturing records for 1 year (21 CFR 558.6(c)(3) and (4)).

In this scenario, your dealer is also considered a distributor because the dealer further distributes the VFD feed to the client. The dealer would need to submit a one-time distributor notification to FDA and follow the other distributor requirements in 21 CFR 558.6 that apply to distributors that do not perform manufacturing of the VFD feed, including keeping a copy of each VFD for 2 years.

As a distributor shipping to another distributor (the dealer), you need to obtain an acknowledgment letter or have one on file from the dealer before you ship the VFD feed, in accordance with 21 CFR 558.6(c)(8). Because you are shipping the VFD feed to the dealer based on an acknowledgement letter provided by the dealer, you do not need to receive a copy of the VFD for the feed from the dealer; the dealer is required to have the VFD and maintain it. However, you must maintain a copy of the acknowledgement letter you receive for 2 years in accordance with 21 CFR 558.6(c)(8).

In addition, as distributors, both you and the dealer are responsible for ensuring any medicated feed you distribute containing a VFD drug or combination VFD drug “complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug.” 21 CFR 558.6(c)(2).

Scenario B – I manufacture the feed and deliver it to the client at the direction of a dealer:

This scenario contemplates a situation where your dealer is a party to the distribution transaction and plays a material role in directing the distribution of the VFD feed to the client, such as by contracting for the delivery of the feed to the client-recipient of the VFD.

In this scenario, you and your dealer both meet the definition of distributor.  Even though your dealer is not physically distributing the VFD feed, the dealer is involved in distribution as a party to the transaction and plays a material role in directing the distribution of the VFD feed. The dealer would need to submit a one-time distributor notification to FDA and follow the other distributor requirements in 21 CFR 558.6 that apply to distributors that do not perform manufacturing of the VFD feed, including keeping a copy of each VFD for 2 years. Because you are shipping/distributing the VFD feed directly to the client, an acknowledgment letter alone from the dealer would not be sufficient.  Instead, the dealer would also need to provide you with a copy of the VFD, and both you and your dealer are required to maintain a copy of the VFD for 2 years.  21 CFR 558.6(a)(4).

In addition, as distributors, both you and the dealer are responsible for ensuring any medicated feed you distribute containing a VFD drug or combination VFD drug “complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug.” 21 CFR 558.6(c)(2).

Scenario C – I manufacture the feed and deliver it to the client; the dealer serves only in a limited support capacity (e.g., sales):

This scenario contemplates a situation where your dealer is not a party to the distribution transaction and does not play a material role in directing the distribution of the VFD feed to the client. In this type of situation, the dealer acts in a limited support capacity related to the transaction, such as processing the sale.

In this scenario, the dealer would not meet the definition of a distributor because the dealer is not a party to the transaction and does not play a material role in directing the distribution of the VFD feed. Consequently, the dealer is not subject to 21 CFR 558.6, and is not required to maintain a copy of the VFD under section 504(a)(3) of the FD&C Act and 21 CFR 558.6(a)(4). Similarly, other parties that are solely involved in facilitating the transport of VFD feed (e.g., third-party logistics providers) and/or transporting VFD feed (e.g., shipping or hauling companies) would not need to receive or retain a copy of the VFD.

The VFD distributor notification letter can be done in a number of ways, so long as it contains the following required information:

• The distributor’s complete name and business address;
• The distributor’s signature or the signature of the distributor’s authorized agent; and
• The date the notification was signed (21 CFR 558.6(c)(5)).

We suggest using a letter format for the notification, with the subject line “VFD Distributor Notification.” The distributor notification must be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Animal Feeds (HFV-220) by mail: 12225 Wilkins Ave., Rockville, MD 20852, Fax: 240-453-6882, or email (via attachment): MedicatedFeedsTeamMail@fda.hhs.gov (21 CFR 558.6(c)(7)).

A single notification may include multiple locations. For multiple locations, each address must be included in the notification. A company with multiple locations may also send separate VFD distributor notifications for each location. Both methods are acceptable as long as they contain the required information described above. A notification from a company that states their intent to distribute at all of their locations but fails to provide the address of each location would not be acceptable.

To be removed from the VFD distributor list, written notification of your request to be removed from the VFD distributor list should be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Animal Feeds (HFV–220) by mail: 12225 Wilkins Ave., Rockville, MD 20852, Fax: 240-453-6882, or email (via attachment): MedicatedFeedsTeamMail@fda.hhs.gov.

There are specific items that must be included in the acknowledgment letter. As specified in 21 CFR 558.3(b)(11), an “acknowledgment letter” is a written (nonverbal) communication provided to a distributor (consignor) from another distributor (consignee) which must affirm:

• That the distributor will not ship such VFD feed to an animal production facility that does not have a VFD,
• That the distributor will not ship such VFD feed to another distributor without receiving a similar written acknowledgment letter, and
• That the distributor has complied with the distributor notification requirements of 21 CFR 558.6(c)(5).

In addition to the affirmation above, we would expect to see the name of the distributor who is sending the acknowledgment letter and the name of the distributor who is receiving the acknowledgment letter.

An acknowledgment letter may cover multiple locations between two distributors. For example, the acknowledgement letter could be written as described above with an appendix that includes all of the locations covered by that acknowledgement letter for each distributor. Each location should have a current copy of the acknowledgment letter and appendices. The appendices could then be updated when the locations operating under the acknowledgment letter change. We recommend that the appendices be dated to easily identify the most current version.

No, there is no requirement in the VFD regulations at 21 CFR 558.6 for distributors to lock up or secure Type A medicated articles, or Type B or C VFD feed. However, some distributors may choose to secure or lock up VFD drugs or feed as one way to meet the requirement that VFD feed can only be distributed after receipt of a valid VFD (or an acknowledgment letter in the case of distribution to another distributor). Other distributors may implement other business practices that would ensure a valid VFD or an acknowledgment letter has been received prior to distribution of the VFD feed and that the distribution of the VFD feed is in compliance with the terms of the VFD. In some instances, a distributor may make a business decision to secure drugs as a method to meet other drug handling requirements (e.g., to maintain control of drug inventory under medicated feed CGMP requirements).

Generally, distributors will package VFD feed in the amount ordinarily used by each client. However, there may be situations wherein a client may be authorized to feed a VFD feed to a smaller than normal group of animals. In those situations, distributors may, but are not required to, repackage the feed into smaller bags.

If you are considering repackaging a Type B or C VFD feed, you may want to contact the VFD feed manufacturer regarding assistance with the labeling requirements and should contact your State feed regulatory agency regarding State requirements. If you choose to repackage medicated feeds, you will need to register with FDA as a food facility and follow the medicated feed CGMP requirements (21 CFR part 225), as well as the CGMP requirements for animal food (21 CFR part 507). In addition, the repackaged product will need to comply with the animal food labeling requirements in 21 CFR part 501, the labeling requirements for medicated feed in 21 CFR part 558 (e.g., following representative labeling), and relevant State requirements (in most cases, your State’s requirements are likely to be inclusive of the requirements found in 21 CFR 501).

Also, please note that repackaging medicated feed does not extend the expiration date of that feed. In addition to the VFD expiration date, the medicated feed itself may have an expiration date specified on the label to ensure the effectiveness of the medicated feed. If no expiration date is on the label, this generally means that the feed is good for up to 3 months from the date of manufacture.10 If you do not want to repackage the medicated feed, you should provide the client with a pre-packaged amount that is most in line with the number of animals authorized on the VFD to be fed the medicated feed.

For example, if 15 lbs. would be appropriate to feed the number of animals indicated on the VFD and the packaged feed is sold in 25 and 50 lb. bags, the distributor should sell the 25-lb. bag. Another example would be if 60 lbs. of VFD feed is appropriate to feed the number of animals indicated on the VFD and the packaged feed is sold in 25 and 50 lb. bags. In this situation, the distributor should sell the client a 25 lb. bag and a 50 lb. bag, not two 50 lb. bags.

It is ultimately the client’s responsibility to feed 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 is not permitted to feed the remaining VFD feed to animals once the VFD expires (21 CFR 558.6(a)(2)). The client could 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.

Yes, distributors or clients can retain VFDs and related records (e.g., acknowledgment letters) received in hardcopy or by electronic means in a standard electronic file format (such as PDF, XML, or SGML), irrespective of whether the computer system on which these records are stored is compliant with 21 CFR part 11. We anticipate that storage as a PDF file will be a common method for the maintenance of these records by distributors and clients.

When VFD feed is transferred between different locations within the same corporate entity, we would not consider the corporate entity to be distributing the VFD feed to another person. Therefore, an acknowledgment letter would not be required for transfers within the same corporate entity.

However, when VFD feed is transferred between different locations that are not part of the same corporate entity, then the person at the first location would be distributing VFD feed to another person (the second location). In this situation, the distributor at the first location would need to maintain a written acknowledgment letter from the distributor at the second location receiving the VFD feed (21 CFR 558.6(c)(8)).

Yes, you may provide a client with nutritionally different diets over the duration of use for a 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 nutritionally different rations under a single VFD so long as each of those rations is consistent with the VFD and the drug approval.

In order to obtain a Type B medicated feed, the client would need to provide the distributor with a VFD. The distributor is responsible for distributing a Type B medicated feed approved for manufacture of the Type C medicated feed specified in the VFD. The distributor and client should work together to determine the appropriate amount of the Type B medicated feed that would result in a commensurate amount of Type C medicated feed for the approximate number of animals identified in the VFD.

After obtaining the Type B medicated feed from the distributor, the client would be responsible for using it to manufacture the Type C medicated feed specified in the VFD. Any client 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.

The client would also be responsible for feeding the Type C medicated feed in accordance with the VFD (21 CFR 558.6(a)(1

Because Type A medicated articles for VFD drugs are not considered VFD feeds, a client does not need to present a VFD 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))). Additionally, a medicated feed mill license approved by FDA is required when manufacturing a Type B or Type C medicated feed from a Type A medicated article that falls into Category II (21 CFR 558.4(a)). Therefore, Type A medicated articles in Category II intended for use in the manufacture of animal feed must not be distributed to a client who does not have a medicated feed mill license. (See statutory text immediately following 21 U.S.C. 360b(a)(1)(D), and 21 CFR 510.7).

Also, the CGMP requirements for Type A medicated articles are found in 21 CFR part 226, which includes some requirements that are applicable to the holding and distribution of a Type A medicated article. For example:

Complete records shall be maintained for each shipment of Type A medicated article(s) in a manner that will facilitate the recall, diversion, or destruction of the Type A medicated article(s), if necessary. Such records shall be retained for at least 2 years after the date of the shipment by the manufacturer and shall include the name and address of the consignee, the date and quantity shipped, and the manufacturing dates, control numbers, or marks identifying the Type A medicated article(s) shipped (21 CFR 226.110).

As stated in the preamble to the 2015 VFD final rule, we expect that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals as specified by the veterinarian in the VFD (80 FR 31708 at 31723, June 3, 2015). VFD distributors, should retain the necessary records to document the amount of feed that was distributed under the VFD. In addition, VFD distributors who manufacturer VFD feed (e.g. feed mills) must retain manufacturing records (21 CFR 558.6(c)(4)). These records should be made available for inspection and copying by FDA upon request.

Since the VFD specifies the number of animals that will be fed and not the exact amount of feed that can be manufactured, distributors can work with the client as batches of feed are shipped under the VFD to adjust the amount of feed as feed consumption rates change among the animals. In the preamble to the 2015 VFD final rule, we discussed the change from the requirement to include the amount of feed to be manufactured on the VFD to the requirement to instead include the approximate number of animals to be treated. In this discussion, we stated that we expect the feed mill to share expertise and work with the client and veterinarian to determine the appropriate amount of feed to be manufactured for the approximate number of animals authorized to be treated under the VFD (80 FR 31708 at 31722, June 3, 2015). We anticipate that, as part of our inspectional activities, we will consider such factors as whether the amount of feed distributed is reasonable relative to the approximate number of animals specified in the VFD.

If we encounter a situation where there has been a violation in the authorization, distribution, or use of a VFD drug or VFD feed, we intend to hold the party who committed the violation responsible. For example, if a distributor appropriately fills a lawful VFD for an approximate number of animals based on reasonable consumption information provided by the client, but the client uses the VFD feed in a manner inconsistent with the terms of the VFD as issued by the veterinarian, we would conduct a follow-up investigation. Based on the results of this investigation, we would consider whether to pursue enforcement against the individual or individuals responsible for any improper activity.

Yes. VFD distributors may be aware of VFD feeds that are commonly ordered by their customers. A VFD distributor that has met the VFD distributor requirements (e.g., one-time notification to FDA) and any applicable licensing requirements for manufacturing medicated feed may manufacture a Type B or C VFD feed in accordance with the VFD drug approval, provided he or she does not distribute the VFD feed until presented with either a lawful VFD from a client or the client’s veterinarian, or an acknowledgement letter from another distributor (21 CFR 558.6(c)(1) and (8)). We anticipate that this may occur in situations where a VFD distributor wants to have retail stock on hand or distributes retail stock under an acknowledgment letter to another VFD distributor such as a farm store.

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

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

The feed mill or any distributor is required to keep records of the receipt and distribution of all medicated feed containing a VFD drug for two years. (558.6(c)(3)).

All involved parties share responsibility in ensuring that a lawful VFD has been issued and the VFD feed is manufactured and used according to the terms of the VFD as issued by the veterinarian. The veterinarian must meet certain requirements (i.e., be licensed to practice veterinary medicine) to issue a lawful VFD. And clients must only feed animal feed containing a VFD drug to animals based on a VFD issued by a licensed veterinarian.

It is the distributor’s responsibility to fill a VFD order only if the VFD contains all required information.

If the VFD 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 necessary information on the VFD is provided. If the feed mill has reason to believe that the information on the VFD is incorrect or untruthful, we would expect that they not fill the VFD and notify their local FDA district office so that we can follow-up.

The rule does not specify responsibility for this situation. This would be part of the business relationship between the manufacturer and distributor and it would be up to those parties to determine how to handle this situation. Disposal of the feed should be in a manner that is in accordance with State or local requirements for medicated feeds.

Manufacture and handling of all medicated feeds, including VFD feeds, is subject to Current Good Manufacturing Practice for Medicated Feeds regulation (CGMP) codified in Title 21 code of Federal Regulations, part 225 (21 CFR 225). Part B contains the regulations for feed mills that are not required to register.

FDA intends to use a phased enforcement startegy for implentation of this final rule as OTC drugs become VFD drugs as a result of GFI #213 implementation. FDA first intends to provide education and training for stakeholders subject to this final rule such as veterinarians, clients (animal producers), feed mill distributors and other distributors. FDA will then engage in risk-based general surveillance, as well as for-cause inspection assignments. FDA intends to use information such as history of VFD use and the volume of feed being produced to focus inspectional resources within the industry based on risk. FDA anticipates that it will utilize various sources for obtaining such information including such sources as FDA food and drug registration information, feed mill licensing information, the VFD distributor notifications FDA receives, and VFD distribution records maintained by drug sponsors and VFD distributors.

The current good manufacturing practice requirements found in 21 CFR 225 apply to the manufacturing of all medicated feeds, including VFD feeds.

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)). The 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

An acknowledgement letter is a letter that a distributor obtains from a consignee-distributor (the distributor receiving the VFD feed) when the distributor ships an animal feed containing a VFD drug in the absence of a valid VFD. The distributor receiving the VFD feed signs and sends the acknowledgement letter. 21 CFR 558.3(b)(11) contains a description of what the acknowledgement letter must affirm.

There is no requirement that the amount of feed be on the VFD order. The VFD order must have the approximate number of animals to be fed the VFD feed by the expiration date of the VFD; indication for which the VFD is issued; and level of VFD drug in the feed and duration of use. This provides flexibility for trained nutritionists to calculate the amount of feed needed. The feed authorized, the manufacturing capacity of the manufacturer, and the storage capacity of the client.

In the final rule (558.3(b)(9)) states that “For the purposes of this part, a ‘‘distributor’’ means 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.” Based on this definition, if the same company is manufacturing and distributing the VFD feed and also feeding VFD feed to the animals (client), they would not be considered a distributor, because they are not distributing the VFD drug to another person. If the company is manufacturing and distributing the VFD, but another person (individual or business entity) is feeding the animals and thus the client, the company would be considered a distributor because they are distributing VFD feed to another person. 

If a distributor is distributing VFD feeds, they must meet all of the requirements in the final rule that are applicable to a distributor, including distributor notification.  To distribute VFD feed, the distributor must first receive either (1) an acknowledgment letter (if distributing the feed to another distributor); or (2) a VFD (if distributing the feed to the client). 

Additional information on requirements for VFD distributors can be found at the following websites:

Veterinary Feed Directive (VFD):
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

Veterinary Feed Directive Requirements for Distributors (Who Manufacture VFD Feed):
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455414.htm

In the case of transfers within the same corporate entity we would not consider the corporate entity to be distributing to another person. Therefore, an acknowledgment letter would not be required for transfers within the same corporate entity.

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)). An acknowledgment letter is provided to another distributor to obtain VFD feed instead of a VFD order. 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)).

A person is defined in the FD&C Act “”The term “person” includes individual, partnership, corporation, and association.”” (201(e) (21 USC 321(3)).

A distributor needs to have provided a one-time notification to FDA of the distributor’s intent to distribute prior to the first time they distribute a VFD feed. For each VFD feed the distributor distributes, the distributor needs to receive either a VFD from any client purchasing the VFD product, or an acknowledgment letter from any distributor purchasing the VFD product. The VFD Final Rule provides specific items that must be included in the distributor notification and the acknowledgment letter.

Distributor Notification

21 CFR 558.6(c)(5) explains what is required for distributor notification.  The notification (we suggest using a letter format, and addressing it to “VFD Distributor Notification”) simply needs to say that the firm intends to distribute animal food that contains a VFD drug.  The notification also needs to contain:

1.       The complete name and address of the distributor’s company,
2.       The name and signature of the distributor or distributor’s authorized agent, and
3.       The date the notification was signed.

If there is a change in ownership, and/or name or address of the business, FDA must be notified within 30 days.  This notification must be mailed or sent by FAX to Food and Drug Administration, Center for Veterinary Medicine, Division of Animal Feeds (HFV–220), 7519 Standish Pl., Rockville, MD 20855, FAX: 240–453–6882.

The only listing requirement is for those feed mills that are considered a distributor. 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)). If an on-farm feed mill is not distributing VFD feed to another person, they are not considered a distributor and do not have to provide a one-time distributor notification to FDA. ​”

Acknowledgment Letter

An acknowledgement letter is a letter that a distributor obtains from a consignee – distributor (the distributor receiving the VFD feed) when the distributor ships an animal feed containing a VFD drug in the absence of a valid VFD. The distributor receiving the VFD feed signs and sends the acknowledgment letter. 21 CFR 558.3(b)(11) contains a description of what the acknowledgment letter must affirm.

The acknowledgment letter must be provided either in hardcopy or through electronic media and must affirm:
1.        That the distributor will not ship such VFD feed to an animal production facility that does not have a VFD.
2.       That the distributor will not ship such VFD feed to another distributor without receiving a similar written acknowledgment letter, an
3.       That the distributor has complied with the distributor notification requirements of § 558.6(c)(5).

In addition to the affirmation above, we would also expect to see the name of the distributor who is receiving the VFD feed and who they are providing the acknowledgment letter to.

Additional information on the VFD Final Rule is available at the following links:
Veterinary Feed Directive: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

GFI #120: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf

If you are distributing Type B or C VFD feed to another person, you are considered a distributor.  The distributor must be in compliance with all of the applicable requirements in § 558.6, with special attention to the requirements applicable to everyone in § 558.6(a) and those specific to distributors in § 558.6(c).  If the distributor is also manufacturing the VFD feed, they will also need to meet the manufacturing requirements.

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 considered a VFD feed and you do not need to receive an acknowledgment letter or VFD prior to distribution.

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.

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.

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)). If an on-farm feed mill is not distributing VFD feed to another person, they are not considered a distributor and do not have to provide a one-time distributor notification to FDA.

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 dedicated 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 done consistent with the conditions of use as set out in the VFD, including expiration dates.

The FD&C Act only requires a VFD or acknowledgment letter for the receipt and distribution or use of a VFD medicated feed. The FD&C Act does not require a VFD or acknowledgment letter for receipt Type A medicated article. However, the animal producer must have a VFD on hand prior to using the Type A medicated article in a VFD feed.

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)). If an on-farm feed mill is not distributing VFD feed to another person, they are not considered a distributor and do not have to provide a one-time distributor notification to FDA. 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.

ome 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 done consistent with the conditions of use as set out in the VFD, including expiration dates.

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.)

On January 1, 2017, all products with approvals that have transitioned from OTC to VFD must be used in compliance with the VFD regulations, even if the product has the old OTC labeling. At the time of transitioning from OTC to VFD marketing status, these products will fall under the 2015 VFD rule that went into effect on October 1, 2015.

On January 1, 2017, the client must have a VFD to authorize the feeding of any VFD feed. If the client already has VFD feed on site, they must receive a VFD authorizing the use of the VFD feed prior to feeding that VFD feed. If they have Type A medicated articles on site they must have a VFD prior to feeding any of the resulting VFD feed mixed from that Type A medicated article.

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

Whether or not the producer is considered a distributor depends on whether the same person (individual or business entity) is (1) distributing the VFD feed; and (2) acting as the client in the context of the veterinarian-client-patient relationship that the VFD has been authorized under. If the same person is doing both of these activities, then the person is not distributing VFD feed to another person and is not a distributor. If different people are doing both of these things, then the person distributing the VFD feed is distributing VFD feed to another person and is therefore a distributor within the context of the VFD rule.

The final rule (558.3(b)(9)) states that “For the purposes of this part, a ‘‘distributor’’ means 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.

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.”

In the situation described, for the purposes of the VCPR and VFD it appears that contract grower is the person who is responsible for feeding the animals the VFD feed, and they would likely be considered the “client.”

If the contract grower is the “client” as previously described, and it is their name on the VFD from a veterinarian, the producer would then be distributing VFD feed to another person, and therefore would be considered a “Distributor” and would need to meet the Distributor requirements in the VFD Final rule.

If the producer is, in fact, the “client” for the purposes of the VCPR and the VFD, they would then be both the distributing the VFD feed and acting as the client. Therefore the producer would not be distributing a VFD feed to another person and would not be considered a distributor under the VFD Final Rule.

On January 1, 2017, the client must have a VFD to authorize the feeding of any VFD feed. If the client already has VFD feed on site, they must receive a VFD authorizing the use of the VFD feed prior to feeding that VFD feed. If they have Type A medicated articles on site they must have a VFD prior to feeding any of the resulting VFD feed mixed from that Type A medicated article.

The original VFD rule required that the veterinarian fill out the VFD with the amount of feed to be manufactured/distributed. The new VFD rule requires the veterinarian to fill out the VFD with the approximate number of animals to be treated. FDA expects the feed mill to share expertise and work with the client and veterinarian to determine the appropriate amount of feed to be manufactured for the approximate number of animals authorized by the VFD, and to retain the necessary records to document the amount of feed that was manufactured under the VFD. FDA expects that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals as specified by the veterinarian in the VFD order. FDA anticipates that, as part of its inspectional activities, it will consider such factors as whether the amount of feed manufactured is reasonable relative to the approximate number of animals specified in the VFD.

It is the distributor’s responsibility to fill a VFD order only if the VFD contains all required information (21 CFR 558.6(b)(3)). VFD requirements for Distributors can be found at the following link:

Veterinary Feed Directive Requirements for Distributors (Who Manufacture VFD Feed):
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455414.htm

The original VFD rule required that the veterinarian fill out the VFD with the amount of feed to be manufactured/distributed. The new VFD rule requires the veterinarian to fill out the VFD with the approximate number of animals to be treated. FDA expects the feed mill to share expertise and work with the client and veterinarian to determine the appropriate amount of feed to be manufactured for the approximate number of animals authorized by the VFD, and to retain the necessary records to document the amount of feed that was manufactured under the VFD. FDA expects that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals as specified by the veterinarian in the VFD order. FDA anticipates that, as part of its inspectional activities, it will consider such factors as whether the amount of feed manufactured is reasonable relative to the approximate number of animals specified in the VFD.

All involved parties share responsibility in ensuring that a lawful VFD has been issued and the VFD feed is manufactured and used according to the terms of the VFD as issued by the veterinarian. The veterinarian must meet certain requirements (i.e. be licensed to practice veterinary medicine) to issue a lawful VFD. And clients must only feed animal feed containing a VFD drug to animals based on a VFD issued by a licensed veterinarian.

It is the distributor’s responsibility to fill a VFD order only if the VFD contains all required information (21 CFR 558.6(b)(3)). VFD requirements for Distributors can be found at the following link: Veterinary Feed Directive Requirements for Distributors (Who Manufacture VFD Feed): http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455414.htm

If the VFD 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. If the feed mill has reason to believe that the information on the VFD is incorrect or untruthful, we would expect that they not fill the VFD and notify their local FDA district office so that we can follow-up.

Clients that have on farm feed mills will inevitably have CTC, OTC, Tylan or other antibiotics.
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)). If an on-farm feed mill is not distributing VFD feed to another person, they are not considered a distributor and do not have to provide a one-time distributor notification to FDA.

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 done consistent with the conditions of use as set out in the VFD, including expiration dates.

The FD&C Act only requires a VFD or acknowledgment letter for the receipt and distribution or use of a VFD medicated feed. Before a distributor ships an animal feed containing a VFD drug (VFD feed) to another distributor (the dealer), the distributor must obtain a VFD or an acknowledgement letter from the distributor receiving the VFD feed (Section 504(a)(3) of the FD&C Act (21 U.S.C. 354(a)(3))). A description of what the acknowledgment letter must include can be found at 21 CFR 558.3(b)(11).

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 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).

In this situation, you are distributing the VFD feed directly to the client even though the order is coming through another distributor. The statute requires that any person involved in the distribution or use of a VFD feed maintain a copy of the VFD for that feed. The only exception in the statute is when the distributor is distributing the VFD feed to another person for further distribution (another distributor). (Section 504(a)(3) of the FD&C Act (21 U.S.C. 354(a)(3))). Therefore, even though your business relationship is with another distributor, you are distributing the VFD feed directly to the client who is not a distributor. Therefore, you must have a VFD for the feed you are distributing. The dealer should also retain a copy of the VFD.

The regulation requires the VFD order to provide the client’s name, business or home address, and telephone number. It also requires the premises at which the animals are located be provided on the VFD. In response to the requirement to enter information describing the premises where the animals are located, we expect that the veterinarian would enter information about the location of the animals that would allow someone to locate the animals. Typically, the address would be an appropriate way to identify the location; however, other generally recognized geographical indicators such a global positioning system (GPS) coordinate may be appropriate if a street address does not exist.

On January 1, 2017, we expect that certain antimicrobial drugs of human medical importance will change marketing status from over-the-counter (OTC) to Veterinary Feed Directive (VFD) for drugs administered through feed or to prescription (Rx) status for drugs administered through water.

Those uses in young animals that are presently approved OTC as a Type A medicated article, or Type B or C medicated feed in 21 CFR 558 (e.g., milk replacers) will become VFD, while those uses that are presently approved OTC to be added to drinking water or milk in 21 CFR 520 (e.g., as soluble powder) will become Rx.

The following website provides a list of all the approved animal drug applications affected by the GFI #213/209 OTC to VFD (or Rx) transition:
http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ ucm390429.htm

List of drugs transitioning from over-the-counter (OTC) to prescription (Rx) status: https://www.fda.gov/animal-veterinary/antimicrobial-resistance/list-approved-new-animal-drug-applications-affected-gfi-263

1) We will not be able to review your form, however, Draft CVM GFI #233: Veterinary Feed Directive Common Format Questions and Answers, was published in December 2015. This guidance recommends a common format for the information to be included on the VFD, provides guidance concerning the required elements of the VFD, and includes examples of how a common format might appear.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-233-veterinary-feed-directive-common-format-questions-and-answers

We anticipate finalizing this draft guidance this year; please check our website to ensure you have the most recent version. CVM Guidance for Industry draft and final documents can be found at:
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm

Additionally, FDA regulations require that an animal drug sponsor who is seeking approval of a drug for use in or on feed as a VFD drug must submit copies of a VFD for review by FDA’s Center for Veterinary Medicine. Once the sponsor’s drug is approved, the VFD form provided by the sponsor will be made available for use by veterinarians when authorizing their client to obtain and use medicated feed containing the VFD drug. You may contact drug sponsors of approved products regarding copies of VFD forms for their specific products; many sponsors may also make VFD forms available online.

2) The veterinarian may choose to work together with a feed distributor when preparing the VFD. However, 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.

The VFD final rule states that 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)). In order for the VFD to be complete, it must include all of the required information elements listed in the VFD regulation (21 CFR 558.6(b)(3)) and may also include the optional information elements (21 CFR 558.6(b)(4)). In draft guidance we recently issued to recommend a common format for VFDs (CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers (PDF – 921KB)), we encourage sponsors of VFD drugs to provide for use by veterinarians a fillable VFD form that is pre-populated with the relevant approved, conditionally approved, or indexed information to assist the veterinarian in issuing a complete and accurate VFD.

The original VFD rule required that the veterinarian fill out the VFD with the amount of feed to be manufactured/distributed. The new VFD rule requires the veterinarian to fill out the VFD with the approximate number of animals to be treated. FDA expects the feed mill to share expertise and work with the client and veterinarian to determine the appropriate amount of feed to be manufactured for the approximate number of animals authorized by the VFD, and to retain the necessary records to document the amount of feed that was manufactured under the VFD. FDA expects that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals as specified by the veterinarian in the VFD order. FDA anticipates that, as part of its inspectional activities, it will consider such factors as whether the amount of feed manufactured is reasonable relative to the approximate number of animals specified in the VFD.

The distributor must keep records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years.

On January 1, 2017, all products with approvals that have transitioned from OTC to VFD must be used in compliance with the VFD regulations, even if the product has the old OTC labeling. At the time of transitioning from OTC to VFD marketing status, these products will fall under the 2015 VFD rule that went into effect on October 1, 2015.

On January 1, 2017, the client must have a VFD to authorize the feeding of any VFD feed. If the client already has VFD feed on site, they must receive a VFD authorizing the use of the VFD feed prior to feeding that VFD feed. If they have Type A medicated articles on site they must have a VFD prior to feeding any of the resulting VFD feed mixed from that Type A medicated article.