Veterinary Feed Directive
FAQ
Client 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 client?
- A client recipient of an animal feed containing a VFD drug or a combination VFD drug must:
- Only feed animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) to animals based on a VFD issued by a licensed veterinarian (21 CFR 558.6(a)(1));
- feed a VFD feed or combination VFD feed to animals by no later than the expiration date on the VFD (21 CFR 558.6(a)(2));
- provide a copy of the VFD order to the distributor if the issuing veterinarian sends the distributor’s copy of the VFD through you, the client (21CFR 558.6(b)(8);
- maintain a copy of the VFD order for a minimum of 2 years (21 CFR 558.6(a)(4)); and
- provide VFD orders for inspection and copying by FDA upon request (21 CFR 558.6(a)(5)).
- A client recipient of an animal feed containing a VFD drug or a combination VFD drug must:
- What is my role as a client in the veterinarian-client-patient-relationship
(VCPR)?
- In order for a VFD to be lawful, the VFD must be issued and used in compliance with all applicable requirements in 21 CFR 558.6. This includes the requirement that the veterinarian must issue the VFD in the context of a state-defined VCPR, or if the VCPR requirements as defined by such state do not include the key elements of the federally-defined valid VCPR or are not applicable to the issuance of a VFD, then the veterinarian must issue the VFD in the context of a valid VCPR as that term is defined in FDA’s regulations at 21 CFR 530.3(i). (21 CFR 558.6(b)(1)(ii)). In those cases where the federally-defined VCPR applies, in order for the VFD to be written in the context of a valid VCPR you, as the client, must agree to follow instructions of the veterinarian (21 CFR 530.3(i)(1)). In those cases where a veterinarian is issuing the VFD in the context of a state-defined VCPR, as a client you must follow the client requirements in the state-defined VCPR.
- Can a client distribute or feed drugs that are not approved as VFD drugs if such
distribution or feeding is authorized by a veterinarian on a VFD order?
- No.
- Can a client feed a VFD feed past the VFD expiration date?
- No. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)).
- I have a VFD order that I would like to use to feed a VFD feed, but the order will
expire before I can complete the duration of use on the order, what should I do?
- The client should contact his/her veterinarian to request a new VFD order. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)).
[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.
- If a producer has medicated feed on their farm on Jaunary 1, 2017, do they need a retroactive VFD for that feed?
- 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 older OTC label. The producer would need a VFD prior to feeding the medicated feed to their animals.
- How will internet pharmacies be regulated in terms of VFD feeds/water solubles?
- OTC drugs administered through drinking water will b transitioning to prescription (Rx) status; nothing in the VFD Final Rule changed how prescription drugs are regulated.
A VFD drug is not a prescription drug. If an internet pharmacy distributes VFD feed to another distributor or client, they would be considered a distributor and need to notify FDA and follow the distributor requirements.
- OTC drugs administered through drinking water will b transitioning to prescription (Rx) status; nothing in the VFD Final Rule changed how prescription drugs are regulated.
- Can an FFA Advisor/4-H leader be considered the "Caretaker" of all the club's animals and therefore have the VCPR with the veterinarian?
- The client's name and address on the VFD should reflect the 'client' in the veterinarian-client-patient relationship. The client is the owner of the animal or animals or other caretaker (i.e., typically the person responsible for the oversight of feeding the animals). An FFA Advisor or 4-H leader could be considered the caretaker provided they are in fact assuming responsibility for the care and feeding of the animals.
- 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)). Thee licensing requirements are the same whether manufacturing medicated feed from OTC or VFD drugs.
Additional information on Medicated Feed Mill licensing can be found at:
http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/default.htm
- A medicated feed mill license is required to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article (21 CFR 558.4(a)). A medicated feed mill license is also required to manufacture certain free-choice medicated feeds (21 CFR 510.455(f)) and liquid medicated feeds (21 CFR 558.5(g)). Thee licensing requirements are the same whether manufacturing medicated feed from OTC or VFD drugs.
[Source: Farm Foundation]
- Producers buy some products from one mill, and other diets/products from a second mill. Do they need a VFD for each mill, or can they write one VFD with all of the products on it?
- The distributor that the veterinarian or client gives the VFD to should be the only distributor filling the entire order.
In special circumstances (e.g., if a mill runs out of a VFD drug and the client needs VFD feed immediately to adhere to the treatment regimen or if a feed mill goes down unexpectedly), there may be a need for two mills to fill the entire order. If that is the case, the client and distributors should all keep records documenting the situation so that it is clear that the animals received only the treatment authorized by the VFD.
It is unclear from the question whether the different feedmills are different locations for one distributor, as multiple feedmill locations could be considered one distributor if owned by the same corporation. A distributor is defined as "any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD." (21 CFR 558.3(b)(9)). A person is defined in 201(e) of the FD&C Act "The term “person” includes individual, partnership, corporation, and association." (21 USC 321(3)). One distributor may have multiple locations and it is acceptable for that distributor to fill a VFD from any of its locations.
However, it is the distributor’s responsibility to comply with the applicable requirements in 21 CFR 558.6(a) and (c), including the requirement to distribute a VFD only if it complies with the terms of the VFD and the requirement to keep records of receipt and distribution of all VFD feed for 2 years. Therefore, we would expect a distributor filling a VFD from multiple locations would have required manufacturing records under 21 CFR 225 and VFD distribution records under 21 CFR 558.6(c) that support that these requirements have been met.
During an inspection we will review VFD orders and compare them to manufacturing records. We would expect that the amount of medicated feed produced to fill that VFD, whether in one or several batches would be commensurate with the amount of feed necessary for the approximate number of animals the VFD authorizes to be fed.
- The distributor that the veterinarian or client gives the VFD to should be the only distributor filling the entire order.
- What about the producer buying and producing his own feed for his own site? Do they need a VFD to purchase product? Do they need acknowledgement/distributor letters? What is the process?
- If the producer is not a distributor, they must have a VFD to receive a Type B or C VFD medicated feed. If the producer is also a distributor (because they will ship feed to another person as defined in 21 CFR 558.3(b)(9)) they can provide either an acknowledgment letter or VFD to their distributor to receive a Type B or C VFD medicated feed.
If the producer is obtaining a Type A medicated article that is not a VFD feed, the producer does not need to provide an acknowledgment letter or VFD to receive the Type A medicated article. The producer will need a VFD prior to feeding any resulting Type C medicated feed that they mix from the Type A medicated article.
The statute states that "Any persons involved in the distribution or use of animal feed bearing or containing a veterinary feed directive drug and the licensed veterinarian issuing the veterinary feed directive shall maintain a copy of the veterinary feed directive applicable to each such feed, except in the case of a person distributing such feed to another person for further distribution. Such person distributing the feed shall maintain a written acknowledgment from the person to whom the feed is shipped stating that that person shall not ship or move such feed to an animal production facility without a veterinary feed directive or ship such feed to another person for further distribution unless that person has provided the same written acknowledgment to its immediate supplier.” (Section 504(a)(3) of the FD&C Act (21 USC 354(a)(3)).
- 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.
- Will my veterinarian have to visit every site I have to do a VFD?
- In order for a veterinarian to write a lawful VFD, the veterinarian issuing the VFD must 1) be licensed to practice veterinary medicine, and 2) be operating within the course of the veterinarians professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter (21 CFR 558.6(b)(1)).
Refer to this link to determine if the State or Federal VCPR Definition applies to a Lawful VFD in your State: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm
A veterinarian would need to meet these requirements for all of the animal locations in order to issue a lawful VFD.
- In order for a veterinarian to write a lawful VFD, the veterinarian issuing the VFD must 1) be licensed to practice veterinary medicine, and 2) be operating within the course of the veterinarians professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter (21 CFR 558.6(b)(1)).
- For a producer who mills their own feed for their owned sites, do they need a VFD to purchase the bulk product from an animal health company? What is their procedure to bring products in?
- Some animal producers manufacture their own medicated feed directly from Type A articles. In this situation, the producer may purchase Type A medicated articles from a sponsor without the VFD, but the producer is required to have a VFD authorizing the use of a VFD feed to be fed to their animals prior to mixing any VFD feed. Some producers manufacture their own medicated feed from a Type B or C medicated feed. In these situations, the producer would need a VFD to obtain a Type B or C medicated feed from a distributor. (Section 504(a)(3) of the FD&C Act (21 U.S.C 354(a)(3))).
We recognize that for producers who manufacture their own medicated feed it may be important to maintain some Type A medicated articles or medicated feed in inventory to manufacture medicated feed quickly in order to provide animals with timely treatment after receiving VFD authorization from their veterinarian. However, the inventory should be appropriate to the expected amount of VFD feed that would be needed to treat that producer’s animals. As a reminder, any VFD feed must be fed under a valid VFD issued by a licensed veterinarian and the use of the VFD feed must be consistent with the conditions of use as set out in the VFD, including expiration dates.
- 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))).
[Source: ISU]