FDA recently released an edited version of its previously released guidance on the Veterinary Feed Directive Regulation fashioned as questions and answers.  (See Guidance #120).

Some of the edited and added Q&A will be discussed in future blogs, but the list of the edited and newly added questions, delineated in the table of contents, is reproduced here for those veterinarians impacted (which includes any veterinarian who issues a VFD for the use of a VFD drug in a medicated feed, regardless of whether the approved use is for a food producing or non-food producing animal.

1. Edited questions:
2. Does the State or Federal definition of a veterinarian-client-patient relationship (VPCR) apply?
3. What information should be included on the VFD to describe the “premises” at which the animals are located?
4. Can a VFD authorize either the approved pioneer or approved generic VFD drug(s)?
5. In cases where a VFD drug is approved for use at multiple drug levels, or for use in a range of drug levels, would one or multiple VFD orders have to be issued to cover such drug uses?
6. What additional information is required on a VFD authorizing the use of a combination VFD drug?
7. Can I write a VFD for an OTC drug?
8. How do I authorize or limit the use of a VFD drug that is approved to be used in combination with OTC drugs?
9. How do I cancel my VFD?
10. Can I make my own VFD form to authorize the use of a VFD drug?
11. What is the Distributor Notification Process?
12. What is an acknowledgment letter?
13. How is an acknowledgment letter different from a distributor notification?
14. If a VFD authorizes the use of a drug(s) that is not approved as a VFD drug or combination VFD drug, can a distributor fill the VFD?
15. Can I have my veterinarian write a VFD to authorize the use of a medicated feed that is not approved for the use I’m intending (i.e., Extralabel use)?
16. Newly added questions:
17. If I am a university researcher and I want to perform research on a drug in medicated feed, do I need a VFD to obtain the medicated feed?
18. Are VFDs only required for food producing animals?
19. Is the listing of multiple premises on the VFD allowed? If so, is it mandatory or optional?
20. Some VFD drugs are approved at a set dose (e.g., mg/head/day), but different drug levels in the feed may be necessary to accomplish that dose over the course of treatment. How should I reflect this on the VFD?
21. Some approvals for use of VFD drugs in feed specify a body weight as part of the indication. When the approval includes body weight as part of the indication, does the VFD need to include estimated body weight of the animals?

6. If a VFD is written to allow VFD drugs to be used in feed in combination with OTC drugs using the affirmation statements, do the withdrawal time, special instructions, and cautionary statements need to include both drugs, or just the VFD drug?
7. I am a distributor/client who receives electronic VFDs and paper VFDs from veterinarians or clients. I would like to store these VFDs as electronic PDFs to meet the VFD regulation for retention. Can I archive required records in a standard electronic file format such as PDF, XML, or SGML?
8. If a staff veterinarian writes a VFD for a company-owned feedmill, for company animals, does the company need to retain one or three copies of the VFD?
9. I am a client that has multiple premises. Do I need to keep a copy of the VFD at each of those premises?
10. Can I authorize a feed through pesticide to be used in a VFD feed? If so, how do I do that?
11. If the VFD has expired for a batch of feed, can I reissue a VFD to use the remaining feed?
12. Pm a veterinarian and I also want to sell VFD feed. What do I have to do?
13. If I’m licensed in one State, can I write a VFD for animals located in another State? What if I have a temporary license in the State where the animals are located?
14. If a VFD label has a duration range in which a VFD can be fed (e.g., 21-42 days), and I authorize the use of the VFD for the full 42 days, can the client decide when to stop feeding the VFD feed after the minimum provided in the range?
15. What if the label for the VFD drug uses the dosage (e.g., mg/head/day) instead of the level of the drug (e.g., g/ton) in the feed? Can I just include the dosage on the VFD?
16. Can I assign an extended withdrawal to a VFD medication even though the producer will be using the VFD feed as labeled (i.e., no Extralabel use)?
17. Can I work with a feed distributor, nutritionist, or other animal health professionals in order to write a VFD?
18. My client will have multiple groups of animals moving through their farm during the time period the VFD covers. Can I write the VFD to include the successive groups of animals that will be on the farm during the time period?
19. Some drug labels have different wording for the duration of use. For example, some say feed for X days and some say feed up to X days. How should I fill out the duration of use on the VFD?
20. Our veterinary clinic has multiple veterinarians. Can any of our veterinarians write a VFD for any of our clients?
21. My client wants to use the VFD to receive a Type B medicated feed. Do I fill out the VFD with the Type B information?
22. My client has minor species. I would like to write a VFD for a therapeutic use of a medicated feed, but there is not an approval for this species What should I do?
23. Do I need to have a laboratory confirmation of disease prior to writing a VFD?
24. If a veterinarian makes a mistake on a VFD and wants to go back and make corrections to the VFD rather than fill out a new VFD, can the veterinarian do that?
25. My client has requested a new VFD to replace the former VFD that will soon expire. Can I fill out the new VFD ahead of time and date it to begin when the previous VFD expires?
26. Who is a distributor?
27. Am I considered a distributor if I manufacture feed in my feed mill and deliver it to animals that I own, but are kept in a barn that is not mine and raised by a contract grower?
28. Can a distributor distribute a VFD feed to a representative of the client (e.g., a family member, or employee)?
29. Can an acknowledgment letter be written to cover multiple shipments of VFD feed?
30. I manufacture a VFD feed and ship a VFD feed to a farmer, but the sales transaction is handled through a dealer who does not physically take possession of or distribute the VFD feed. What are my responsibilities and what are the dealer’s responsibilities?
31. What is needed in a distributor notification and can a distributor notification cover multiple locations?
32. What is needed in an acknowledgment letter and can an acknowledgment letter cover multiple locations between the distributors?
33. Do I need to hold VFD drugs or feed in a secure or locked area?
34. Do I have to repackage VFD feed into smaller amounts if the client does not need all of the VFD feed in a bag? If I don’t repackage, will I be responsible for keeping track of the extra amount the client has on hand?
35. I am a distributor with multiple locations. Can I fill a VFD from any of my locations?
36. I am a distributor with multiple locations. Do I need a VFD or acknowledgment letter to transfer VFD feed between my locations?
37. Can I provide a client with nutritionally different diets over the duration of use for a VFD?
38. The client wants to purchase a Type B medicated feed under the VFD. If I distribute a Type B medicated feed, what are my responsibilities and what are the animal producer’s responsibilities?
39. I want to distribute a Type A medicated article to a client. Do I need a VFD from the client? Are there additional requirements for distributing Type A medicated articles?
40. Now that the VFD has the approximate number of animals instead of the amount of feed, what are my responsibilities as a distributor to make sure that the client is not receiving too much feed under the VFD? Will the FDA take enforcement action against me if a client over-orders or misuses a VFD feed?
41. Can I manufacture VFD feed to have on hand before a client comes in with a VFD?
42. Do I have to use the same distributor to obtain all of the VFD feed on a VFD?
43. What do I do if I need to treat animals for a specific duration (e.g , 30 days) but need to receive the VFD feed from two separate mills? For example, because of the animals’ growth stage and needs, one mill will provide the ration for animals during the first 20 days of the VFD’s duration and another mill will provide the ration for animals during the last 10 days of the VFD’s duration
44. I feed my animals several different rations based on their nutritional needs during each growth stage. I have a VFD with a duration of use that will encompass several of these growth stages. Can my feed mill provide me VFD feed with different formulations over the duration of the VFD?
45. I have a VFD that authorizes me to feed my animals for 5 days as indicated on the drug approval. What happens if the animals get sick again? Can I use the same VFD to get additional VFD feed and feed the animals again for 5 days? Can the veterinarian write the VFD to allow me to use the VFD feed for more than one 5-day period prior to the 6-month expiration date?
46. I am currently feeding my animals a VFD feed under a valid VFD. I would like to transfer ownership of my animals. May I do that?
47. Does the VFD feed authorized by a VFD need to be shipped in one load, or can it be delivered in multiple loads?
48. My animals are in the United States, but I receive my feed from Canada. Can I get a VFD feed from Canada and if so what are the requirements?
49. The veterinarian used an affirmation statement to indicate that I can feed the VFD feed in combination with an over-the-counter (OTC) drug. Is it okay for me to feed the VFD drug alone?
50. I want to get a Type A medicated article and manufacture my own feed. What are the requirements?
51. When I purchase a Type A medicated article to create an authorized Type C VFD feed, where does the copy of the VFD intended for the distributor go?
52. I have 4 months remaining on my VFD and I would like to get my VFD feed from a different distributor. Can I ask my veterinarian to cancel the first VFD and issue a new VFD to the second distributor?
53. I am a client. Do I need to keep any records describing my use of the VFD feed in addition to keeping the VFD?

More to come on this soon.

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