Veterinary Feed Directive

FAQ

Distributor/Feed Mill Topics

(Clicking on the source link at the end of each topic section will take you to the original document from which the questions and answers were derived.)

  • What are my responsibilities as a distributor?
    • 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 VFD drugs (21 CFR 558.6(c)(5)). The notice should be sent to FDA, Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), 7519 Standish Pl., Rockville, MD 20855 (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 order 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 VFD orders for two 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 VFD orders for inspection and copying by FDA upon request (21CFR 558.6(a)(5));
      • 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 the originating distributor (consignor), 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)).
  • What is the Distributor Notification Process?
    • A distributor must submit a one-time notification to FDA of its intent to distribute medicated
      feed containing a VFD drug (21 CFR 558.6(c)(5)). 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)). 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, an animal producer (the client) may also be a distributor. When a manufacturer
      of a Type B VFD feed distributes the Type B VFD feed to an animal producer, the animal
      producer 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 an animal producer who is a distributor that has sent a onetime
      notification to FDA, the animal producer must supply either an acknowledgment letter (see
      also answer to question #5 below “What is an acknowledgment letter and how is it different than
      a distributor notification?”) or a VFD for the receipt of the Type B VFD feed from the
      distributor. (§ 558.6(c)(2) and (8)) (Note: In order for the animal producer 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. (§ 558.6(c)(5)) If the animal producer provides an acknowledgment
      letter to the distributor from whom the animal producer receives the VFD feed, the animal
      producer 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. (§ 558.6(c)(2) and (8)).
  • When is a distributor required to submit an updated notification to the FDA?
    • An updated notification is required within 30 days of any change in ownership, business name, or business address (21 CFR 558.6(c)(6)).
  • Is there a publicly available VFD distributor notification list?
  • What is an acknowledgment letter and how is it different than a distributor notification?
    • 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. Specifically, an “acknowledgement letter” is 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: (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; and (3) that the distributor has complied with the distributor notification requirements in 21 CFR 558.6(c)(5). (21 CFR 558.3(b)(11)) The acknowledgment letter allows a distributor to have VFD feed on hand so that when a client gives them a valid VFD they can fill the VFD immediately.

      An acknowledgment letter is different than a distributor notification. 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)).
  • When is a medicated feed mill license required?
    • 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.
  • Is a medicated feed mill license required when a medicated feed containing a VFD drug is manufactured from a Type A medicated article?
    • 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.
  • What should the distributor do if the VFD is not completely filled out?
    • The veterinarian must ensure that all required information is fully and accurately included on the VFD (21 CFR 558.6(b)(3)). The distributor is permitted to fill a VFD only if the VFD contains all required information (21 CFR 558.6(c)(1)). If it does not contain all of the required information, the distributor must not fulfill the VFD and we recommend that the distributor notify the veterinarian that the order cannot be filled until all the necessary information on the VFD is provided.
  • If a VFD authorizes the use of a drug(s) that is not approved as a VFD, can a distributor fill the VFD order?
    • No.

[Source: FDA GFI 120]

  • What is the proper method of disposal for VFD feed that is no longer needed/left over?
    • Disposal of the feed should be in a manner that is in accordance with State or local requirements for medicated feeds.
  • How will electronic VFDs work? What constitutes a valid signature (part 11)? does Global Vet Link satisfy requirements for the vet, producer and feed mill?
    • 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
  • Does the feed mill have to indicate how much medicated feed they produced?
    • 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)).
  • Is the feedmill responsible for ensuring the VFD is valid (licensed vet, etc.)?
    • 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.
  • If a feed manufacturer sends a truckload of medicated feed to the distributor, and they don't sell it all, who is responsible for bringing it back to the manufacturer, disposing of it, etc.?
    • 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.
  • How will small operations that are not inspected for GMPs be regulated and inspected?
    • 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.
  • Will VFD feed in the future be treated as VFD feed has been in the past with respect to blending, carryover, flushing and sequencing, or will it be treated like a ~ 1900 drug?
    • The current good manufacturing practice requirements found in 21 CFR 225 apply to the manufacturing of all medicated feeds, including VFD feeds.
  • If a producer/client conducts on farm mixing of a Type B medicated feed containing a category II VFD drug, does the producer/client need to get a feed mill license?
    • 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
  • Who signs and sends an acknowledgement 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 acknowledgement letter. 21 CFR 558.3(b)(11) contains a description of what the acknowledgement letter must affirm.
  • For feed mixing and delivery purposes must the DVM/client/distributor calculate based on feed batches and full loads, or will short loads need to be produced (and charged for) for the duration of use calculations?
    • There is no requirement that the anount 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.

[Source: Farm Foundation]

  • Clarify the producer owned feed mill situation. Does a producer need a distributor letter or a VFD? Does it matter if all of the pigs are on the mill site? Does it matter if the producer owns sites away from his farm or if those sites are contract finisher sites even though he owns all of the pigs? 
    • 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)).
  • Confusion regarding the “One Time” Distributor Notification and the “Acknowledgement Letter”.  What is the difference and when does each come into play?
    • 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
  • I’m not sure where distributors who plan to inventory/sell VFD feed grade antibiotics in bulk fit into this VFD process? Can distributors sell directly to the farm if the producer has a current valid VFD?
    • 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.

[Source: ISU]

Feed coming from multiple feed mills

  • Many feedyards "bid" a supplement for 30 days. If a veterinarian writes a script for 6 months but the "bid" changes between feed mills every 30 days, how does FDA handle that?
    • 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.
  • Pulmotil is to be fed for 21 continuous days. The first seven days is Phase 1 and is fed by Mill A. The last 14 days is fed in Phase 2 by Mill B. How should the VFD be written? 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.

On-Farm milling

  • What about a farmer who makes his own feed for his own use? Are they a distributor? If not, can they still purchase the medication with a VFD?
    • 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.
  • Would a farmer need to send an acknowledgement letter to CVM before purchasing a Type A medicated article or Type B medicated feed if they intend to manufacture the VFD feed at their farm? The farmer does have a VFD from a vet.
    • 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.
  • If a customer buys a 50 lb. bag of CTC 50 to mix his own feed, does he need a VFD to purchase the bag and then need a VFD for the Type C feed that he makes from the CTC 50?
    • 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.
  • If there is leftover feed at one site with a VFD can it be transported to another site or group? If so, what documentation would be needed?
    • 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.)
  • If the end user has some VFD product left over; how do they dispose of it or can it be left on hand until needed again?
    • 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.
  • For producers milling their on feed on the farm, do they have to a "distributor" if they own the pigs but deliver to a contract site that takes care of their pigs?
    • 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.

Feed mill enforcement

  • What should be done with any leftover VFD drug on the farm?
    • 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.
  • How long will retailers have to sell their existing stocks of the drugs that are coming under the VFD rule?
    • 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 become subject to the requirements in the VFD rule that went into effect on October 1, 2015.

      A lawful VFD is required to obtain and use medicated feed containing a VFD drug (VFD feed). Beginning January 1, 2017, FDA intends to initiate surveillance and compliance activities to ensure that the products making this transition are being used in compliance with the applicable VFD requirements.

      FDA recommends that parties involved in the production and/or distribution of the affected VFD products proactively manage product inventories to limit the amount of OTC-labeled product that will remain on shelves when these products are transitioned to VFD status on January 1, 2017.

      This was also addressed in FDA's letter to potential distributors (retailers) regarding implementation of Guidance for Industry (GFI) 213: http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ ucm507353.htm
  • Does the feed mill have to monitor the quantity of a VFD feed a customer buys or only that there is a VFD that has not expired?
    • 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
  • Will all VFDs state the amount feed a mill can sell a client holding a valid VFD within the stated expiration timeframe? Is the feed mill solely responsible for enforcement?
    • 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.

Clarifying Definition of a Distributor and Documentation Needed

  • Is a client that has leftover Type A antibiotic on their location a distributor?
    • 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.
  • If I am a manufacturer that makes a VFD feed, but it is distributed by someone else, do I have to get the VFD in hand to manufacture?
    • 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).
  • Clarify the broker scenario: If a veterinarian sells a mineral w/ CTC to a client but the client picks up the mineral at the feed mill but the vet handles the financial transaction is the vet 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).

      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.

Labeling/Transition Labels

  • Can feed in inventory January 1, 2017, without a transition label be re-labeled with a sticker or new label with the VFD statements?
    • 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 become subject to the requirements in the VFD rule that went into effect on October 1, 2015.

      A lawful VFD is required to obtain and use medicated feed containing a VFD drug (VFD feed). Beginning January 1, 2017, FDA intends to initiate surveillance and compliance activities to ensure that the products making this transition are being used in compliance with the applicable VFD requirements.

      FDA recommends that parties involved in the production and/or distribution of the affected VFD products proactively manage product inventories to limit the amount of OTC-labeled product that will remain on shelves when these products are transitioned to VFD status on January 1, 2017.

      This was also addressed in FDA's letter to potential distributors (retailers) regarding implementation of Guidance for Industry (GFI) 213:
      http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ ucm507353.htm
  • What is the premises definition? Is it the actual pasture the animals are in or can the main office/headquarters address be listed for the premises address.
    • 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.
  • Is milk replacer considered a VFD or RX?
  • If we make a form for veterinarians to fill out for our clients, can we submit that to the FDA and they can approve that we have all the fields that we need to have in order to be compliant? Then, if they approve it, can we use that form, since there won't be a standardized one?
    • 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.
      http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ UCM474640.pdf

      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.
  • In regard to the scenario with the customer who orders more feed than their VFD order is for and we deliver the 3 ton but only have a 1 1/2 ton VFD is there a timeline for them to get the revised VFD to the feed mill?
    • 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.
  • What should happen to the distributor copy of a VFD order in the scenario that a producer has leftover medicated feed after the VFD expires? Or if the producer has VFD containing feed on his premises on January 1, 2017?
    • 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.

[Source: Feedstuffs]