#120  
 
Veterinary  Feed  Directive Regulation  
Questions  and Answers (Revised)  
 
Draft  Guidance for Industry  
 
Small  Entity Compliance  Guide  
 
This draft revised  guidance  document  is for comment purposes only.  
 
This  draft  guidance document makes revisions to  the final guidance made available in September  
2015  to provide additional information regarding the  VFD final rule  that  published in June  
2015.  
 
Submit comments on this  draft revised  guidance  by the date  provided in the  Federal Register  
notice  announcing the  availability of the guidance.  Submit electronic comments to  
https://www.regulations.gov/.  Submit written  comments to the Dockets Management  Staff 
(HFA-305), Food and Drug Administration,  5630 Fishers Lane, Rm. 1061, Rockville, MD  
20852. All comments should be identified with the Docket  No: FDA-2010-N-0155.  
 
For further information regarding this document, contact  Dragan Momcilovic, Center for  
Veterinary Medicine  (HFV-226), Food and Drug Administration, 7519 Standish Place, 
Rockville, MD 20855, 240-402-5944, e-mail: dragan.momcilovic@fda.hhs.gov.  
 
Additional copies of this guidance document  may be requested from the  Policy and Regulations  
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500  Standish 
Place, Rockville, MD 20855, and may be viewed on the Internet at either  
https://www.fda.gov/AnimalVeterinary/default.htm  or  https://www.regulations.gov/.  
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Veterinary Medicine  
March  2019     Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
Table of Contents  
 
 
I.   INTRODUCTION ..................................................................................................................  9  
II.   VETERINARY FEED DIRECTIVE    General Information ...............................................  10  
A.   Veterinary Feed Directive Drugs .....................................................................................10  
1.   What is a veterinary feed directive drug?  ..............................................................  10  
2.   Who determines whether a drug is VFD drug? ......................................................  10  
3.   What is a combination veterinary feed directive drug?  .........................................  10  
4.   What are Category I  and Category II  drugs and what is  their relevance to VFD  
drugs?  .....................................................................................................................  10  
5.   [Added 2019] 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?  ..............  11  
B.   Veterinary Feed Directive (VFD) ....................................................................................11  
1.   What is a Veterinary Feed Directive?  ....................................................................  11  
2.   What is required for a VFD to be lawful?  ..........................................................  11  
3.   [Revised 2019] Does the State or Federal definition of a veterinarian-client-patient 
relationship (VPCR) apply?  ...................................................................................  12  
4.   [Added 2019] Are VFDs only required for food producing animals? ...................  12  
C.   Information on the VFD  ..................................................................................................12  
1.   What specific information must the veterinarian include on the VFD and what  
information is optional?  .........................................................................................  12  
2.   Who is the client for the purpose of filling the  VFD? ........................................  13  
3.   [Revised 2019]  What information should be included on the  VFD to describe  the  
premises at which the animals are located? ........................................................  14  
4.   [Added 2019] Is the listing of  multiple premises  on the VFD allowed?   If so, is it 
mandatory or optional?  ..........................................................................................  14  
5.   What is an expiration date on the  VFD?.............................................................  15  
6.   How is the expiration date determined by the veterinarian for a VFD? .............  15  
7.   What is the  duration of use and how does it relate to the expiration date? .....  15  
8.   What is the  approximate number of  animals on the VFD?  ................................  16  
9.   [Revised 2019] Can a VFD authorize either the  approved pioneer or  approved 
generic VFD drug(s)? .............................................................................................  16  
2   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
10.   [Revised 2019] 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?.....................................................................  17  
11.   [Added 2019] 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?  ................................  17  
12.   [Added 2019] 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?  ......................................................................................  .......  18  
13.   [Revised 2019]  What additional information is required on a  VFD authorizing the  
use of a combination VFD drug?............................................................................18  
14.   [Added 2019] 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? .................................................................................................  19  
15.   Do these regulations allow reorders and refills? ....................................................  19  
16.   What is an extralabel use of a VFD drug and is  it allowed?  ..............................  19  
D.   VFD Transmission and Recordkeeping ...........................................................................20  
1.   How can a VFD be transmitted to the distributor?  ................................................  20  
2.   Is the veterinarian  required to send  the original VFD to the distributor?  ..............  20  
3.   Can a VFD  be transmitted by telephone?  ..............................................................  20  
4.   Can a VFD  be transmitted to the distributor by  the Internet? ................................  20  
5.   Who is responsible for distributing the VFD?  .......................................................  21  
6.   How long must a VFD be kept and who must keep them? ....................................  21  
7.   In what format can the original VFD be kept by the veterinarian?  ....................  21  
8.   What is 21 CFR part 11 and how does it  apply to the issuance of electronic    
VFDs?  ....................................................................................................................  21  
9.   [Added 2019] 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?  .........................  21  
10.   Can a third-party server  company require  testing of its clients  computers before  
starting  to transmit VFDs?  .....................................................................................  22  
11.   [Added 2019] 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? ......................................................................................................................  22  
3   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
12.   [Added 2019] I am a client that has multiple premises.  Do I  need to keep a copy 
of the VFD  at each of those premises?  ..................................................................  22  
III.   QUESTIONS AND ANSWERS SPECIFIC TO INVOLVED PARTIES ...........................  22  
A.   Veterinarian  .....................................................................................................................22  
1.   What are my responsibilities as a veterinarian? .....................................................  22  
2.   [Revised 2019] Can I write a VFD for an OTC drug? ...........................................  23  
3.   [Revised 2019] How do I authorize or limit the use of a VFD  drug that is  approved 
to be used in combination with OTC  drugs? ..........................................................  23  
4.   [Added 2019] Can I authorize  a feed through pesticide to be  used in a VFD feed?   
If so, how do I do that?...........................................................................................  24  
5.   Other than the required information, what other  information may I include in the  
VFD? ......................................................................................................................  25  
6.   How can I transmit an electronic VFD to the distributor immediately if my third-
party computer server holds all VFDs and only transmits them  once per day (e.g., 
midnight)?  ..............................................................................................................  25  
7.   [Revised 2019] How do I cancel my VFD? ...........................................................  25  
8.   In the past, I issued paper VFDs.  Must all VFDs be issued electronically now?  .  26  
9.   How do I obtain a VFD form  for a VFD drug?......................................................  26  
10.   [Revised 2019] Can I  make my own VFD  form to authorize the use of a VFD  
drug? .......................................................................................................................  26  
11.   [Added 2019] If the VFD has expired for a batch of feed, can I reissue a VFD to  
use the remaining feed? ..........................................................................................  26  
12.   [Added 2019] I'm a veterinarian and  I also want  to sell VFD feed.  What do I have 
to do? ......................................................................................................................  26  
13.   [Added 2019] 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?.............................................................................................................  27  
14.   [Added 2019] 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?  .....................................................................................................................  27  
15.   [Added 2019]  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?  ............................................................................  28  
16.   [Added 2019] 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)?  .......................................................................................................................  28  
4   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
17.   [Added 2019] Can I work with a feed distributor, nutritionist, or other  animal  
health professionals in order to write a VFD?  .......................................................  28  
18.   [Added 2019] 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? ....................................................................................................................  29  
19.   [Added 2019] 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?  ..................................................  29  
20.   [Added 2019] Our veterinary clinic  has multiple veterinarians.  Can any of our  
veterinarians write a VFD for any of our clients? ..................................................  29  
21.   [Added 2019] 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?  .............................................  30  
22.   [Added 2019] 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?  ..................................................................................................  30  
23.   [Added 2019] Do I need to have a  laboratory confirmation of  disease prior to  
writing a  VFD? .......................................................................................................  30  
24.   [Added 2019] 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? ...............................................................................................  30  
25.   [Added 2019] 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?  ...........................................................................  31  
B.   Distributor ........................................................................................................................31  
1.   [Added 2019]  Who is a  distributor? .......................................................................  31  
2.   What are my responsibilities as a distributor?  .......................................................  31  
3.   [Revised  2019]  What is the Distributor Notification Process?  ..............................  32  
4.   When is a distributor  required to submit an updated notification to the FDA?  .....  33  
5.   Is there a publicly available VFD distributor notification  list? ..............................  33  
6.   [Revised 2019]  What is an acknowledgment letter? ..............................................  33  
7.   [Revised 2019] How is  an acknowledgment letter different from a distributor  
notification?  ...........................................................................................................  33  
8.   When is a medicated feed  mill license required? ...................................................  33  
9.   Is a medicated feed mill license required when a medicated feed containing a VFD  
drug is manufactured from a Type A  medicated article? .......................................  34  
10.   What should the distributor do if the  VFD is not completely filled out? ...............  34  
5   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
11.   [Revised  2019] 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?  ..................  34  
12.   [Added 2019] 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?  ..................................................................................  34  
13.   [Added 2019] Can a distributor distribute a VFD feed to a representative of the 
client (e.g.,  a family member, or employee)?  ........................................................  35  
14.   [Added 2019] Can an acknowledgment letter be  written to cover multiple  
shipments of VFD feed?  ........................................................................................  35  
15.   [Added 2019] 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? .............................................................................  35  
16.   [Added 2019]  What is needed in a distributor notification and can a distributor  
notification  cover multiple locations? ....................................................................  36  
17.   [Added 2019]  What is needed in an acknowledgment letter  and can an 
acknowledgment letter cover multiple locations between the distributors?  ..........  36  
18.   [Added 2019] Do I need to hold VFD drugs or feed in a secure or locked area? ..  37  
19.   [Added 2019] 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?  ...........  37  
20.   [Added 2019] I am a distributor with  multiple  locations.  Can  I fill a VFD from 
any of  my locations?  ..............................................................................................  38  
21.   [Added 2019] I am a distributor with  multiple  locations.  Do I need a VFD or 
acknowledgment  letter to transfer VFD feed between  my locations?  ...................  38  
22.   [Added 2019] Can I provide a client with nutritionally different diets over the  
duration of use for a VFD?.....................................................................................  39  
23.   [Added 2019] 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  
24.   [Added 2019] 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  
25.   [Added 2019] 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? ....  40  
26.   [Added 2019]  Can I  manufacture VFD feed to have on hand before a client comes  
in with a VFD? .......................................................................................................  41  
C.   Client  ...............................................................................................................................41  
6   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
1.   What are my responsibilities as a client?  ...............................................................  41  
2.   What is my  role as  a client in the veterinarian-client-patient-relationship   
(VCPR)? .................................................................................................................  41  
3.   [Revised  2019] Can I have my veterinarian write a VFD to authorize the use of a 
medicated feed that is not approved for the use Im intending (i.e., extralabel    
use)?  .......................................................................................................................  42  
4.   Can I feed my animals a VFD feed  after the VFD expiration date? ......................  42  
5.   I have a VFD that I would like to use to feed a VFD feed, but the VFD will expire  
before I can complete the duration of use on the  VFD.  What should I do? ..........  42  
6.   [Added 2019] Do I have to use the same distributor to obtain all of the VFD feed  
on a VFD?  ..............................................................................................................  43  
7.   [Added 2019]  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 VFDs duration and another mill will 
provide  the ration for animals during the last 10 days of the VFDs duration.......  43  
8.   [Added 2019] 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?  ...........................  43  
9.   [Added 2019] 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? ........................  44  
10.   [Added 2019] 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?  .......................  44  
11.   [Added 2019] Does the VFD  feed authorized by a VFD need to be shipped in one  
load, or can it be delivered in multiple loads?  .......................................................  45  
12.   [Added 2019] 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? 
  45  
13.   [Added 2019] 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? .......................................................................  45  
14.   [Added 2019] I want to get a Type A  medicated article and  manufacture  my own  
feed.   What are the requirements? ..........................................................................  46  
15.   [Added 2019]  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? ..........................................................................................................................  46  
7   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
16.   [Added 2019] 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? ...........................................  46  
17.   [Added 2019] I am a client.  Do I need  to keep any records describing my use of  
the VFD feed in addition to keeping the VFD?  .....................................................  47  
   
8   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
Veterinary Feed Directive Regulation  
Questions and Answers  (Revised)  
 
Guidance for Industry  
 
Small Entity Compliance  Guide  
 
This  draft  guidance, when finalized, will  represent  the  current thinking of the  Food and Drug 
Administration (FDA or  we) on this topic.  It does not  establish  any rights for any person and is 
not binding on  FDA or the public.  You can use an alternative approach if  it  satisfies the 
requirements of the applicable  statutes and regulations.  To discuss an alternative approach, 
contact  the  FDA staff responsible  for this guidance using the  contact  information on the title  
page.  
 
I.   INTRODUCTION  
 
Before 1996, there were  only two options for dispensing new  animal drugs: (1) over-the-counter  
(OTC), and (2) prescription.  In 1996, Congress enacted the Animal Drug Availability Act  
(ADAA) to facilitate the approval  and  marketing  of new animal drugs and  medicated feeds.  As 
part of the ADAA, Congress recognized that certain new animal drugs intended for use in animal  
feed should only be administered under a veterinarian's order and professional supervision.  For  
example, veterinarians are needed to  control the use of certain antimicrobials.  Control is critical 
to reducing unnecessary use of such drugs in animals and to slowing or preventing any potential  
for the development of bacterial resistance  to antimicrobial drugs.  Safety concerns  relating to 
difficulty of diagnosis of  disease  conditions, high toxicity, or other reasons  may also dictate  that  
the use of a  medicated feed be limited to use by order and under the supervision of a  licensed 
veterinarian.  Therefore,  the ADAA created a new category of products called veterinary feed  
directive (VFD) drugs.  
 
In June 2015, FDA published a final rule  that  revised the VFD regulations in 21 CFR 558.6 and 
introduced clarifying changes to the definitions in 21 CFR 558.3 (80 FR 31708, June 3, 2015).  
This guidance provides information to assist veterinarians, VFD feed distributors (e.g., feed 
mills), and clients (i.e., owners or other caretakers of the animals) in complying with  the  
requirements in the 2015 VFD  final rule.  This guidance also serves as a Small Entity  
Compliance  Guide (SECG), to aid industry in complying with the requirements of the VFD  final  
rule.  FDA has prepared this SECG in accordance  with section 212 of the Small Business  
Regulatory  Enforcement Fairness Act  (Public Law 104-121).  This document is intended to 
provide guidance to small businesses on the requirements of the final rule.  
 
Generally, FDA guidance documents, including this guidance, do not establish legally  
enforceable responsibilities.  Instead, guidance describes the  Agencys current  thinking on a  
topic and should be viewed only as  recommendations, unless specific  regulatory or statutory 
requirements are cited.  The use of the word should  in Agency guidance  means that something is  
suggested or recommended, but not  required.  
9   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
 
To assist our stakeholders, in this revised draft guidance we have identified those Questions and  
Answers that contain revised information and those that have  been added since  the last version of  
the guidance published in September 2015.  We  have also made minor edits to improve clarity 
and accuracy.  
II.   VETERINARY FEED DIRECTIVE   General Information  
 
A.   Veterinary  Feed Directive Drugs  
 
1.   What is a veterinary  feed  directive  drug?  
 
A veterinary feed directive (VFD)  drug  is a drug intended for use in or  on animal feed which is  
limited by an approved new animal drug application filed pursuant  to section 512(b)  of the  
Federal Food, Drug, and Cosmetic Act (the FD&C Act), a conditionally approved application 
filed pursuant to  section 571 of the FD&C Act, or an index listing pursuant to section 572 of the  
FD&C Act to use under  the professional supervision of a licensed veterinarian (21 CFR  
558.3(b)(6)).   Use of animal feed bearing or containing a VFD drug (VFD feed)  must be 
authorized by a lawful VFD (21 CFR 558.6(a)(1)).   See section  II.B.  Veterinary Feed Directive 
(VFD)  below for a discussion of what constitutes a lawful VFD.  
 
2.   Who determines  whether a drug is VFD drug?  
 
When a new  animal drug application  is submitted  to FDAs Center for Veterinary  Medicine  
(CVM) for approval, CVM evaluates the drug for  safety and effectiveness,  and as part of the 
review process, determines whether  the drug will be an over-the-counter (OTC) drug, a  
prescription (Rx) drug, or a VFD drug (limited to drugs used in or on animal feed).  
 
3.   What is a combination veterinary  feed  directive  drug?  
 
A "combination veterinary feed directive  drug  (or combination VFD drug)  is  a combination 
new animal drug (as defined in  514.4(c)(1)(i))  intended for  use in or on animal feed which is  
limited by an approved application filed pursuant to section 512(b) of the FD&C Act, a  
conditionally approved application filed pursuant to section 571 of the FD&C Act, or an index 
listing pursuant to section 572 of the  FD&C Act to use under  the professional supervision of a  
licensed veterinarian, and at least one of the new animal drugs in the  combination is a VFD drug. 
Use of animal feed bearing or containing a combination VFD drug must be authorized by a  
lawful veterinary feed directive (21 CFR 558.3(b)(12)).   If any component  drug in an approved, 
conditionally approved, or indexed combination drug is a VFD drug, the  combination drug is a  
combination VFD drug and its use must comply  with the  VFD requirements.  
 
4.   What are Category I  and Category II  drugs and what is  their relevance to VFD  
drugs?  
 
All new animal drugs, including VFD drugs, approved for use in or on animal feed are placed in 
one of two drug categories, Category I or Category II (21 CFR 558.3(b)(1)).  Category I drugs  
10   Contains Nonbinding Recommendations 
Draft  Not for Implementation 
require no withdrawal period at the lowest use level in each species for which they are approved. 
Category II drugs either require a withdrawal period at the lowest use level for at least one major 
species for which they are approved, or are regulated on a no-residue basis or with a zero 
tolerance because of carcinogenic concern regardless of whether a withdrawal period is required 
in any species. 
A medicated feed mill license is required if the VFD drug used to manufacture a Type B or Type 
C medicated feed is a Category II, Type A medicated article (21 CFR 558.4(a)). A list of 
Category II drugs is located in 21 CFR 558.4(d).1  A license is not required if the VFD drug used 
to manufacture a Type B or Type C medicated feed is a Category I Type A medicated article, 
with the exception of certain liquid and free-choice medicated feeds. 
5.  [Added 2019] 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? 
No, you do not need a VFD to obtain medicated feed for the purpose of performing research on a 
drug for use in or on a medicated feed. The VFD regulations apply to the use of VFD drugs and 
VFD feed for approved indications.  When investigating a new indication during the approval 
process, or performing tests in vitro or in animals used only for laboratory research purposes, the 
VFD regulations do not apply.  Instead, the requirements in 21 CFR part 511 New Animal 
Drugs for Investigational Use apply. When pursuing a new animal drug approval, the 
requirements in 511.1(a) or 511.1(b) may apply depending on the purpose for the research trial. 
For research that is not related to pursuing a new animal drug approval, the requirements in 21 
CFR 511.1(a) apply.  21 CFR part 511 can be viewed at: http://www.ecfr.gov.2 
B.  Veterinary Feed Directive (VFD) 
1.  What is a Veterinary Feed Directive? 
A veterinary feed directive is a written (nonverbal) statement issued by a licensed veterinarian 
in the course of the veterinarians professional practice that orders the use of a VFD drug or 
combination VFD drug in or on an animal feed.  This written statement authorizes the client (the 
owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or 
containing a VFD drug or combination VFD drug to treat the clients animals only in accordance 
with the conditions for use approved, conditionally approved, or indexed by the FDA (21 CFR 
558.3(b)(7)).  A VFD may also be referred to as a VFD order. 
2.  What is required for a VFD to be lawful? 
To be lawful, a VFD must be issued and used in compliance with all applicable requirements in 
21 CFR 558.6. These include the requirement that a VFD must be issued by a veterinarian 
licensed to practice veterinary medicine operating in the course of the veterinarian's professional 
1 https://www.ecfr.gov/cgi-bin/text-
idx?SID=b8e74620d2b65cd5c35fb00efa6dbcd9&mc=true&node=pt21.6.558&rgn=div5%20-%20se21.6.558_14
2 https://www.ecfr.gov/cgi-bin/ECFR?page=browse 
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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 (21 CFR 558.6(b)(1)).  If applicable VCPR requirements as defined by such 
state do not  include  the  key elements of a valid VCPR as defined in FDAs regulations at 21 
CFR 530.3(i), the veterinarian must issue the VFD in the context of a valid VCPR as defined in 
21 CFR 530.3(i).  
 
3.   [Revised  2019] Does the State or Federal definition of a veterinarian-client-patient 
relationship  (VPCR)  apply?  
 
In those  States that require a VCPR that includes the key elements of the Federally-defined 
VCPR in order for a veterinarian to issue a VFD, the veterinarian issuing the VFD  must be  
operating within the context of a VCPR as that term is defined by the  State.   In all other cases,  
the veterinarian must be operating within the context of  a valid VCPR as  defined by FDA in 21 
CFR 530.3(i).  (21 CFR  558.6(b)(1)(ii)).  FDA considers  States with VCPR definitions that at 
least address the concepts that  the veterinarian  (1) engage with  the client  to assume responsibility  
for  making clinical judgments about patient health, (2) have sufficient knowledge of the patient  
by virtue of patient examination and/or visits to the facility where patient is managed, and (3)  
provide for  any necessary follow-up evaluation or care to include the key elements of the  
Federally-defined VCPR as set forth in 21 CFR  530.3(i).  
 
In States where the veterinary practice requirements do not require that a VFD be issued within  
the context  of a  State-defined VCPR that  includes the key elements of a valid VCPR as defined 
in Federal regulations at  21 CFR  530.3(i), FDA is requiring that the VFD be issued within the  
context of a  Federally-defined valid VCPR as defined at 21 CFR   530.3(i).  (21 CFR 
558.6(b)(1)(ii)).  
 
FDA has  worked  with State regulatory authorities to verify whether  their  State has VCPR 
requirements in place that apply  to the issuance of a VFD and include the key elements of the 
Federally-defined VCPR.  FDA has compiled  a list of states that require a VCPR that includes  
the key elements of the  Federally-defined VCPR in order for a veterinarian  to issue a VFD.  This 
list  is  available online3  and  the  list will be updated periodically as FDA receives and verifies 
information from  States if they change their VCPR definition or its applicability.  
 
4.   [Added 2019] Are  VFDs  only required for  food producing animals?  
 
No.  A VFD is required  to authorize 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.  
 
C.   Information on the VFD  
 
1.   What specific information must the veterinarian include on the VFD  and what  
information is optional?  
 
                                                 
3  https://www.fda.gov/animalveterinary/developmentapprovalprocess/ucm071807.htm  
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21 CFR 558.6(b)(3) requires  the following information to be fully and accurately included on the  
VFD order:  
 
   The  veterinarians name, address, and telephone number;  
   the  clients name, business or home address, and telephone number;  
   the  premises at which the animals specified in  the VFD are located;  
   the  date of VFD issuance;  
   the  expiration date of the VFD;  
   the  name  of  the VFD drug(s);   
   the  species and production class of animals to be fed the VFD feed;  
   the  approximate number of animals to be fed the VFD  feed by the expiration date of the  
VFD;  
   the  indication for which the VFD is issued;  
   the  level of VFD drug in the feed and duration of use;  
   the  withdrawal time, special instructions, and cautionary statements necessary for use of  
the drug in conformance with the approval;  
   the  number of reorders  (refills) authorized, if permitted by the drug approval, conditional  
approval, or  index listing;  
   the statement: Use of feed containing this veterinary feed directive (VFD) drug in a 
manner other than as directed on  the  labeling (extralabel use), is not permitted;  
   an affirmation of intent  for combination VFD drugs as described in 21 CFR 558.6(b)(6);  
and  
   the  veterinarians electronic or written signature.  
 
In addition to the information described above that must be included on the VFD, the  
veterinarian also may, at his or her discretion, include on the  VFD the following additional  
information as described in 21 CFR  558.6(b)(4) to more specifically identify the animals he or  
she is authorizing to be treated using the VFD feed:  
 
   A  more specific description of the location of the  animals (for example, by site, pen, 
barn, stall, tank,  or other descriptor the veterinarian deems appropriate);  
   the  approximate age range of the animals;  
   the  approximate weight range of the animals; and  
   any other information the veterinarian deems appropriate to  identify the animals at issue.  
 
2.   Who is the client for the purpose of filling  the  VFD?  
 
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For purposes of the VFD regulations, the term client typically  refers to the person  responsible 
for the care  and feeding of the animals receiving the VFD feed.  As described in the definition of  
the  term veterinary feed directive, the client may be the owner of  the animals or other 
caretaker  (see 21 CFR 558.3(b)(7)).  
 
3.   [Revised  2019] What information should be included on the  VFD  to describe the  
premises at which the animals are located?  
 
We  expect that the veterinarian would enter  information about the physical location of  the  
animals referred to  in the VFD that would be sufficiently descriptive  to  allow someone to locate  
the animals.  Typically, the street address for the facility would be an appropriate way to identify 
the animals location; however, other generally recognized geographical indicators,  such a global  
positioning system (GPS) coordinate  or  Federal grazing land  identification information 
(allotment),  may be appropriate if a street address does not exist.  
 
We recognize that  an address for a facility may not provide enough information to identify the  
location of animals in a case where the VFD is meant to authorize the VFD feed to be provided  
to a very specific group of animals.   As a result, the veterinarian may use  his or her discretion to 
enter  additional information on the VFD that more specifically describes the location of the  
animals,  such as the site, pen, barn, stall, tank, or  other descriptor (21 CFR 558.6(b)(4)(i)).   The  
veterinarian should consult  with the  client  to determine whether the  animals will remain at this  
more specific location until the expiration date of the VFD.  
 
We  also  understand that  some groups of animals that are of similar age, weight  range, etc., are  
managed in a similar manner, but may be housed in different  physical locations.   For example, a  
group of weaned pigs may be moved out of a nursery facility and transferred to multiple grow-
out facilities for finishing.   If a VFD  is intended to authorize the  use of a VFD  feed in an  
identified group (approximate number) of animals that are located at more than one physical  
location, it is acceptable  for a veterinarian  to include multiple specified  locations for that group  
of animals on the VFD.   In the preamble  of the VFD final rule, we stated  that  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). (80 FR  31708  at 31720, June 3, 
2015, see response to Comment 27).  
 
4.   [Added 2019] Is the listing of multiple premises  on the VFD  allowed?   If so, is it 
mandatory or optional?  
 
Yes, it is allowed.  It is optional to group two or more  premises on one VFD or on separate VFDs,  
and  depends on whether  one VFD can be written to cover  the  animals on multiple premises.   In 
the preamble to the final rule, we discussed how VFDs  may be written for groups of animals  
with a similar age, weight range,  etc., that are managed in a similar manner but housed at  
multiple premises.   In the preamble  of the VFD  final rule, we stated, 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 
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professional licensing and practice standards and provided the VFD  feed is supplied to such 
multiple  locations by  a single feed manufacturer (distributor).   (80 FR  31708  at 31720, June 3, 
2015, see response to Comment 27).  Alternatively, the veterinarian may choose to write separate  
VFDs for each premise.  
 
5.   What is an expiration date on the  VFD?  
 
The expiration date on the VFD specifies the last day the VFD feed can be fed.  In other words, 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)).  
 
6.   How is the expiration date determined by the veterinarian for a VFD?  
 
In certain  cases, FDA determines the expiration date of a VFD (the number of days the VFD feed  
can be fed to the animal  before  the VFD  expires) as part of the approval, conditional approval, or  
index listing of that drug.  The VFD  expiration date defines  the period of  time for which the  
authorization to feed an animal feed containing a VFD drug is lawful.  The expiration date for  
the VFD  must not extend beyond the  expiration date specified in that drugs approval, 
conditional  approval, or  index listing (21 CFR 558.6(b)(3)(v)).  
 
In cases where the  expiration date is  not specified in the approval, conditional approval, or  index 
listing, the expiration date of the VFD  must not exceed 6 months after  the date of issuance (21 
CFR 558.6(b)(3)(v)).  This provision allows veterinarians, based on their  medical judgment and 
knowledge of the animal production operation, to determine on a case-by-case basis whether  the 
maximum 6-month period is an appropriate expiration date for the VFD, or whether  a  more  
limited period  is warranted.  The veterinarian will use his or her medical judgment to  determine 
what expiration date  is appropriate for the VFD, based on many factors including, but  not limited 
to, the  type  of animal production facility and operation, the VFD drug or combination VFD drug 
at issue, the  intended use of the VFD  drug, and the health status, treatment history, and lifecycle  
of the animals.  
 
The date of expiration should be calculated by the calendar  date, not  the number of  days.  For  
example, using a 6-month expiration date for a VFD, if the VFD is written on July 10, then the  
expiration date would be January 10 of the following year.  Using the same 6-month expiration 
date example, but having the VFD written on the last day of the month, the VFD expiration date 
would be the last day of the sixth month even if that month has fewer days.  Thus, in this  
example, if the VFD is written on August 31, the  expiration date would be the following 
February 28 during a regular calendar year, or February 29 during a  leap year.  
 
7.   What is the  duration of use and how does it relate to the  expiration date?  
 
The VFD expiration date defines the  period of time  for which the authorization to feed an animal  
feed containing a VFD drug is lawful.   This period of time  may be specified in the approved 
labeling of a given VFD drug or, if not specified in the  labeling, the veterinarian must specify an 
expiration date for the VFD that does not exceed 6 months (21 CFR 558.6(b)(3)(v)).   The  
duration of use is a separate  concept  from the  expiration date, and determines the  length of time, 
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established as part of the approval, conditional  approval, or  index listing process, that the animal  
feed containing the VFD drug is allowed to be fed to the animals.  This period of time is  
specified in  the labeling of the VFD  drug.  For example, for swine, the currently approved VFD  
drug tilmicosin has an expiration date of  90  days and a duration of use of  21 days.  This means  
that when the VFD is issued, the  client  has 90  days to obtain the VFD feed and complete the 21-
day course of therapy.  It is unlawful  to feed the VFD  feed  to animals after the VFD expiration  
date (21 CFR 558.6(a)(2)).  
 
8.   What is the  approximate number of  animals on the VFD?  
 
The approximate number of animals is the potential number of animals of  the species and  
production class identified on the VFD that will be fed the VFD feed or combination VFD feed 
at the  specified premises by the expiration date of the VFD (21 CFR 558.6(b)(3)(viii)).  
 
9.   [Revised  2019] Can a VFD authorize either the  approved pioneer  or approved 
generic VFD drug(s)?  
 
The veterinarian is required to write the name of the VFD drug on the VFD (21 CFR  
558.6(b)(3)(vi)).  To complete this requirement, the veterinarian may choose to write  the  
established  name of the VFD drug (i.e., active drug ingredient), or  the proprietary name (i.e., 
trade name) of the approved pioneer  or an approved generic (if available)  VFD drug.   
 
Established Name on VFD  
When the veterinarian uses a VFD with the established name of a VFD drug on it, the distributor  
may fill the  VFD order using VFD feed manufactured from any VFD drug containing the same  
active pharmaceutical ingredient (API) approved for the use, i.e., from  either an approved 
pioneer or an approved generic.   
 
Proprietary Name on VFD  
When the veterinarian uses a VFD with the proprietary name  of a VFD drug on it, he/she may 
choose to specify that  a substitution by the distributor of the  VFD  feed of either the  pioneer or  
generic VFD drug identified under a proprietary name on the VFD is not allowed; or, the  
veterinarian may choose  to remain silent, i.e., not  specify that  a substitution is not allowed.   
 
When the veterinarian specifies that a substitution of a proprietary name of the VFD drug is not  
allowed, the distributor  must fill the  VFD using VFD  feed manufactured from the VFD drug 
identified by the proprietary name.  
 
When the VFD is silent  about whether substitution is allowed, then substitution is  allowed, and 
the distributor may fill the VFD using VFD  feed manufactured from any VFD drug containing 
the same API approved for the use, i.e., from either an approved pioneer or an approved generic.  
In other words, any pioneer or generic VFD drug may be used to  substitute for any other pioneer  
or generic drug containing the same API, provided that  the substituting drug is approved for the  
same uses as the drug written on the  VFD, either  alone or  in a combination with other  drugs, as  
the drug identified on the VFD.  The use of a VFD drug must be consistent with the  Blue Bird 
label for  the  VFD drug (pioneer or generic) the distributor uses, and the  labeling of the VFD feed 
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must be consistent with  the Blue Bird label for the VFD drug (pioneer or generic) the distributor 
actually uses in the VFD feed.  
 
10.   [Revised  2019] 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?  
 
In cases where  a VFD drug is approved for use at  multiple drug concentrations, or  levels, for a  
single indication, the veterinarian may issue a single VFD order covering all  those approved drug 
levels intended to be used, and the approved duration(s) of feeding the VFD  feed at the approved 
drug level(s)  for the  indication.  
 
If a  VFD drug is approved for use within a range of drug levels, then the veterinarian may 
specify a particular drug level  within that range  or authorize  use at  any drug level within the  
range by putting the entire authorized range on the VFD.  
 
The veterinarian may also use the special instructions  area of the VFD  to provide more  
specific  instructions about the use of a drug that is approved for use within a range of  drug 
levels.   For example, if  a VFD drug can be used within a certain drug level  within the approved 
range and the veterinarian would like the client  to use a higher drug concentration within that  
range for a certain part of the treatment duration and a lower drug concentration within  that range  
for another  part of the  treatment duration, the special instructions area could be used for that  
purpose.  The distributor  would then need to provide the  client  batches of  VFD feed  that include  
the different drug levels specified  in  the special  instructions  area of the VFD.  
 
11.   [Added 2019] 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?  
 
In cases where the veterinarian  issuing a VFD  has to  determine the drug concentration in g/ton in 
feed because the concentration was not  determined at the time of approval, conditional approval, 
or  index  listing, the veterinarian may need  to authorize use of more than one drug level  in the  
VFD feed  on a VFD to achieve the approved dose.  This may be necessary for reasons such as  
variations in  animal weights  or  feed intake  over the course of therapy.  
 
In situations where g/ton is not provided by approval, conditional approval, or  index  listing, the  
veterinarian could determine that more than one drug level  in the VFD feed  is needed to address  
a particular feeding situation.  For example, the veterinarian could determine that  the drug level  
in the VFD feed  should be 20 g/ton at feed intake  of 2% body weight,  40 g/ton at feed intake of  
1% body weight,  or 15 g/ton at feed intake of 2.5% body weight  to ensure consumption at  the  
approved dosage in mg/head/day or  mg/unit body weight/day).  The veterinarian should include  
this  information in the drug level area  on the VFD  and explain  in the special  instructions area 
that  the observed feed intake will dictate which of the drug levels on the VFD is to be  used.  This  
will ensure that the instructions  on the VFD are  consistent  with the approved representative 
labeling for  use in the  Type B and Type C  medicated feeds containing the new animal drug  (Blue  
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Bird label).  The  Blue  Bird labels often provide  examples, which may be useful to the  
veterinarian in determining what level of VFD drug in the feed may be appropriate.  
 
It  would not  be appropriate for the veterinarian to lump those discrete drug levels into a range  
and then provide a drug range on the  VFD. Such an action would be of a limited use to the  
distributor and producer and could conflict with the  approval and the  approved Blue Bird label.  
 
12.   [Added 2019] 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?  
 
The  estimated  body weight of the animals  does not generally need to be  included in  order  for the  
VFD to be valid.   However, there may be instances when information related to the body weight  
of the animals  may  need  to be included on the VFD as part of  the information from the approval.   
For example, the approved conditions of use for some applications stipulate the body weight of  
treated animals (e.g., feed to animals >700 lbs.  body weight).   In  this situation, this information  
would need to be identified on the VFD as part of the description of  species and production class.  
 
The  VFD regulation does not preclude the veterinarian from including information about the  
weight of the animals on the VFD.   If the issuing veterinarian  chooses to include the approximate  
weight range of the animals on the VFD, he or she  can do so  under  21 CFR 558.6(b)(4), which  
permits  the veterinarian to  include  (iv) Any other information the veterinarian deems  
appropriate  to identify the animals specified in the  VFD.  
 
When information about  the  animals  body  weight is necessary to determine the  appropriate  
amount of  feed, we encourage distributors, veterinarians, and clients to work together  to share  
the necessary information about the  animals to determine the appropriate  amount of  feed for the  
approximate number of animals authorized by the VFD.  
 
13.   [Revised 2019] What additional information is required on a  VFD authorizing the  
use of a combination VFD drug?  
 
A VFD authorizing the use of a combination VFD drug that contains  two or more VFD drugs is  
required to include the name of the drugs in the combination, the indication(s) of use, the levels  
of the drugs  in the VFD feed and duration of use, the withdrawal time, special  instructions, and 
cautionary statements necessary for use of the combination VFD drug required by the  approval  
(21 CFR 558.6(b)(5)) (i.e., the drug-specific  information specified in 21 CFR 558.6(b)(3)(vi),  
(ix), (x), and (xi) for each VFD drug in the combination).  
 
The veterinarian may expand or  limit the use of a VFD drug along with one or more OTC animal  
drugs in an approved, conditionally approved, or indexed combination VFD drug by completing 
the drug-specific information specified in 21 CFR 558.6(b)(3)(vi), (ix), (x), and (xi) for the use  
of  the VFD  drug(s)  and by including one of the following affirmation of intent statements (21 
CFR 558.6(b)(6)):  
 
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   This VFD only authorizes the use of the VFD drug(s)  cited in this order  and is not  
intended to authorize the use of such drug(s)  in combination with any other animal  
drugs.  
   This VFD authorizes  the use of the VFD drug(s) cited in this order  in the following 
FDA-approved, conditionally approved, or indexed combination(s)  in medicated feed that  
contains the  VFD drug(s) as a component.   [List specific approved, conditionally  
approved, or  indexed  combination medicated feeds following this statement.]  
   This VFD authorizes  the use of the VFD drug(s) cited in this order  in any FDA-
approved, conditionally approved, or indexed combination(s) in medicated feed that  
contains the  VFD drug(s) as a component.  
 
14.   [Added 2019]  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?  
 
If a veterinarian is authorizing a VFD drug in combination with an OTC drug(s)  through the use  
of affirmation statements on the VFD, it is not required  to list the withdrawal time, special 
instructions, and warning statements for the OTC drugs authorized in the combination.   The VFD  
is required to include  information for the VFD drug, i.e., the  cautionary statements for the VFD  
drug and indication the  VFD is authorizing.   However, we  do not object  to the veterinarian 
including the cautionary statements for the OTC drugs on the VFD if  he or she  chooses  to do so.  
In contrast, the requirements for labeling the resulting VFD feed are different than for the VFD  
order.   If a combination is used, we would expect  the labeling for the VFD combination feed to  
include  all  relevant cautions including those for the OTC drugs included in the  combination VFD 
feed.  
 
A VFD authorizing the use of a combination VFD drug that contains  two or more VFD drug(s)  is  
required  to include the name of the drugs in the combination, the indication(s) of use, the levels  
of the drugs  in the VFD feed and duration of use, the withdrawal time, special  instructions, and 
cautionary statements necessary for use of the combination VFD drug  required by the approval  
(21 CFR 558.6(b)(5)) (i.e., the drug-specific  information specified in 21 CFR 558.6(b)(3)(vi),  
(ix), (x), and (xi) for each VFD drug in the combination).  
 
15.   Do these  regulations  allow reorders  and refills?  
 
The regulation allows  the issuing veterinarian  to  authorize reorders  (refills) of the VFD only if  
reorders (refills) are explicitly permitted by the drug approval, conditional  approval, or  index 
listing.  In  cases where  reorders  (refills) are not specified on the labeling for an approved, 
conditionally approved, or index listed VFD drug, reorders (refills) are not permitted (21 CFR  
558.6(b)(3)(xii)).  
 
16.   What is an extralabel use of a VFD drug and is  it allowed?  
 
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Extralabel  use is defined in FDAs regulations as actual or  intended use  of a drug in an animal  
in a manner that  is not  in accordance  with the approved labeling (21 CFR  530.3(a)).  For  
example, feeding the animals VFD feed for a duration of time that  is different from the duration 
specified on the label, feeding VFD  feed formulated with a drug level that is different from what 
is specified  on the label, or feeding  VFD  feed to an animal species different than what is 
specified on  the label would all be considered  extralabel uses.  
 
Extralabel use of  medicated feed, including medicated feed containing a  VFD drug or a  
combination VFD drug, is not permitted  (21 U.S.C. 360b(a);  21 CFR 530.11(b) and 558.6(a)(3)).  
Use of  medicated feeds, including those containing a VFD drug or a combination VFD drug, is  
limited to the approved, conditionally approved, or indexed conditions  of use (21 U.S.C. 
360b(a); 21 CFR 558.6(a)(3)).  
 
The VFD  must include the statement  Use of feed containing this veterinary feed directive 
(VFD) drug in a manner other  than as directed on the labeling (extralabel use) is not permitted. 
(21 CFR 558.6(b)(3)(xiii)).  
 
For a discussion of extralabel use of VFD  feed for minor species, please see Question  III.A.22.  
[Added 2019]  My client has a 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?  
 
D.   VFD Transmission and Recordkeeping  
 
1.   How can a VFD be transmitted to the distributor?  
 
A veterinarian must send a copy of the VFD to the distributor  in hardcopy,  by facsimile (fax), or  
by electronic means.   If  the veterinarian sends  the VFD in hardcopy, he or she  must send the  
copy of the VFD to the distributor either directly or through the client  (21 CFR 558.6(b)(8)).  
 
2.   Is the veterinarian required to send the original  VFD to the distributor?  
 
No, the veterinarian  is not required  to send the original hardcopy to the  distributor.   The  
veterinarian  must retain the original VFD in its original form  (electronic or hardcopy).   The  
distributor and client copies may be kept either  as an electronic copy or hardcopy (21 CFR  
558.6(a)(4)).  
 
3.   Can a VFD  be transmitted by telephone?  
 
The veterinarian is required to issue a written (nonverbal) VFD (21 CFR  558.6(b)(7)).  
Therefore, a VFD  may not be issued verbally, including verbal transmission by telephone.  A  
VFD  may be sent by facsimile (fax).  
 
4.   Can a VFD  be transmitted  to the distributor by  the Internet?  
 
Yes.   According to 21 CFR 558.6(b)(8), a VFD must  be sent to the distributor  via hardcopy, 
facsimile (fax), or electronically.  The term  electronically includes  sending  via the Internet.   
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For example, transmitting the VFD electronically includes using the Internet  to transmit the 
image of a paper VFD (e.g., emailing a scanned VFD document) or using the Internet  to transmit  
an electronic VFD generated  in a system that is shown to be in compliance with FDAs 
regulations  at 21 CFR part 11.  For  additional  information about how part 11 applies to the VFD  
process, see discussion at  Question II.D.8. What is 21 CFR part 11 and how does it apply to the  
issuance of  electronic VFDs?  
 
5.   Who is  responsible for distributing the VFD?  
 
The veterinarian must retain the original VFD in its original form (electronic or hardcopy) (21  
CFR 558.6(a)(4)).  In addition, the veterinarian is required to send a copy to the distributor  
directly or, if sending the VFD in hardcopy, either directly or through the client (21 CFR  
558.6(b)(8)), and the veterinarian is  also required to give a  copy of the VFD to the client (21 
CFR 558.6(b)(9)).   Thus, it is  the veterinarians obligation to  ensure that the VFD is distributed  
to the client and the  distributor.  
 
6.   How long must  a VFD be kept and who must keep them?  
 
All involved parties (veterinarian,  client,  and distributor) must retain a  copy of the VFD for 2 
years.  The veterinarian  is required  to keep the VFD in its original format.   The distributor and 
client copies  may be kept as an electronic copy or hardcopy (21 CFR 558.6(a)(4)).  
 
7.   In what format can the original VFD be kept  by the veterinarian?  
 
The veterinarian must retain the original VFD in its original form  (electronic or hardcopy) (21  
CFR 558.6(a)(4)).  
 
8.   What is 21 CFR part 11 and how does it  apply to the issuance of electronic VFDs?  
 
21 CFR part 11 sets out  the criteria under which the  Agency considers  electronic records, 
electronic signatures, and handwritten signatures executed to electronic  records  to be generally 
equivalent to paper records and handwritten signatures  executed on paper.  
 
21 CFR part 11 applies to records  in electronic form that are created, modified, maintained, 
archived, retrieved, or  transmitted under any FDA records requirements.  Therefore, electronic 
VFDs issued by veterinarians must  be compliant with 21 CFR part 11, and electronic VFDs  
received  and  electronically stored by distributors  and clients  must also be compliant with 21 CFR  
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.  
 
9.   [Added 2019] 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?  
 
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Draft   Not for  Implementation  
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.  
 
10.   Can a third-party server company require testing  of its clients computers before 
starting  to transmit VFDs?  
 
Whether or  not third-party server companies require  testing  of their clients computers for 
compatibility with their systems before starting to provide  the clients with their service is a  
business decision between third-party server  companies and their clients and not an FDA  
requirement.  
 
11.   [Added 2019] 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?  
 
The VFD regulation  identifies three parties    veterinarian, producer, and the VFD feed 
distributor    as the parties that are  required  to keep the  record of a VFD.   If one entity  represents 
the veterinarian, the distributor, and the client, it is  acceptable for the VFD to be stored in one 
location provided that everyone required to have a copy has access  and can provide  a copy to the  
FDA investigator upon request.  
 
12.   [Added 2019] I am a client that has  multiple premises.  Do I need  to keep  a copy  of 
the VFD at each  of those  premises?  
 
No, a  client  who keeps animals at multiple premises is not required to keep a copy of the VFD at  
each location where animals reside.  It is acceptable for the VFD to be stored in one location; 
however, if the client  is not directly feeding the  animals at each location (e.g., an employee is  
feeding the animals), then the VFD should be made available to those responsible for the direct  
care of the animals  so that they  can feed the VFD feed in accordance with  the VFD as required 
by the VFD rule.  This may be done by having a physical copy of the VFD  at each location, or it  
may be done by providing electronic  access  to the VFD that is stored in a central location.  Either 
way, the client is required to have a copy of the VFD.  If an inspector  requests a copy during an 
inspection  at one  location, the client  (or their employee) must be in possession of the  VFD or  
must have a  way to readily  access the VFD.  
 
III.   QUESTIONS AND ANSWERS SPECIFIC TO INVOLVED PARTIES  
 
A.   Veterinarian  
 
1.   What are my responsibilities as a veterinarian?  
 
In order for  a VFD to be lawful, the veterinarian issuing the VFD:  
   Must  be licensed to practice veterinary medicine (21 CFR 558.6(b)(1)(i));  
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   must be operating in the  course of the veterinarians professional practice and in 
compliance with all applicable veterinary licensing and practice requirements (21 
CFR 558.6(b)(1)(ii));  
   must  only write  a VFD in the context of a veterinarian-client-patient relationship  
(VCPR) (21 CFR 558.6(b)(1)(ii));  
   must  only issue a VFD that is  in compliance with the conditions for use  approved, 
conditionally approved, or indexed for the VFD drug or combination VFD drug (21 
CFR 558.6(b)(2));  
   must prepare a written (nonverbal)  VFD (21 CFR 558.6(b)(7)) that includes the  
veterinarians electronic  or written signature (21 CFR  558.6(b)(3)(xv));  
   must ensure  the VFD includes all required information specified in the VFD  
regulation (21 CFR 558.6(b)(3));  
   may enter additional discretionary  information to  more specifically identify  the  
animals to be treated/fed the VFD feed (21 CFR 558.6(b)(4));  
   must  include certain drug-specific information for each VFD drug when the  
veterinarian is authorizing the use of a drug combination that includes more than one  
VFD drug  (21 CFR 558.6(b)(5));  
   for VFD drugs approved for use alone or in combination with one or more OTC  
drugs, must  include on the VFD an affirmation of intent either to restrict authorized 
use only to the VFD drug cited on the VFD or to allow the use of the cited VFD drug 
in an approved combination with one or more OTC drug(s) (21 CFR 558.6(b)(6));  
   must  provide the distributor with a copy of the VFD (21 CFR 558.6(b)(8));  
   must  provide the client  with a copy of the VFD  (21 CFR 558.6(b)(9));  
   must retain the original VFD  for 2 years (21  CFR 558.6(a)(4)); and  
   must provide VFDs  for inspection and copying by FDA upon request  (21 CFR  
558.6(a)(5)).  
 
2.   [Revised  2019] Can  I write a VFD for an OTC drug?  
 
No,  a veterinarian may only write a  VFD  for drugs  that  have been  approved, conditionally 
approved, or indexed  as  VFD drugs by the FDA (21 U.S.C. 354).   However,  where the 
veterinarian  is authorizing the use of a VFD  drug  approved for use in combination with one or  
more OTC drugs, the veterinarian may include  certain information about the OTC drug(s) on the  
VFD.   For  further discussion about  the information to be included on the  VFD  when the  
veterinarian authorizes VFD  drug  combinations  that include  both VFD and OTC drugs, please 
see Question II.C.14. [Added 2019]  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?  
 
3.   [Revised  2019] How do I authorize or limit the use of a VFD  drug that is  approved 
to be used in combination with OTC  drugs?  
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Some VFD  drugs are  approved for use alone or in a combination with one or more OTC drug(s).  
In those circumstances, the issuing veterinarian would specify on the VFD whether he or she  
authorizes  the VFD drug to be used alone or  in an approved drug combination with one or more  
OTC drug(s).  In accordance with 21 CFR 558.6(b)(6), the veterinarian is  required to affirm his  
or her intent by including one of the following three statements on the VFD:  
 
   This VFD only authorizes the use of the VFD drug(s)  cited in this order  and is not  
intended to authorize the use of such drug(s)  in combination with any other animal  
drugs.  
  This statement is used  if the veterinarian does not authorize the VFD drug to be  
o 
used in combination with any other  animal drug in the medicated feed.   For those  
VFD drugs that are only approved as  a single ingredient Type A  medicated  
article, i.e., there  are  no approved combinations  that contain the VFD drug as a  
component, this statement  is the only one  of the three statements that can be 
selected and  it must be included in the VFD.  
 
   This VFD authorizes  the use of the VFD drug(s) cited in this order  in the following 
FDA-approved, conditionally approved, or indexed combination(s)  in medicated feed that  
contains the  VFD drug(s) as a component.  [List specific approved, conditionally 
approved, or indexed  combination medicated feeds following this statement.]  
  This statement is used  if the veterinarian chooses to authorize the use of the VFD  
o 
drug(s) only in specific  combination(s); the  veterinarian  may only list approved, 
conditionally approved, or  indexed combination(s)  that contain the VFD drug.  
The client is authorized to use the VFD drug(s)  in  medicated feed  either  alone or  
in those specific combinations  that  the veterinarian has  specified on the VFD.  
 
   This VFD authorizes  the use of the VFD drug(s) cited in this order  in any FDA-
approved, conditionally approved, or indexed combination(s) in medicated feed that  
contains the  VFD drug(s) as a component.  
  This statement is used  if  the veterinarian authorizes the use of the VFD drug(s) in 
o 
any  approved combination  that contains the VFD drug.  The client is authorized  
to use the VFD drug(s) either alone or in any approved, conditionally approved, 
or indexed  combination with the OTC drug(s) in  the medicated feed.  
 
4.   [Added 2019] Can  I authorize  a feed through pesticide to be  used in a VFD feed?   
If so, how do I do that?  
 
An  EPA-registered  feed  through pesticide  may be added  to most  medicated feeds,  including 
VFD feed.  However, adding a  feed  through pesticide to a liquid medicated feed or free-choice 
dry/liquid medicated feed  would require  a specific FDA approval.   Addition of a feed through 
pesticide  to these types of feeds would affect the  approved formula/specifications, which could 
affect  the safety profile  of the medicated feed  by altering the  drug intake  and drug stability.  
 
24   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
It would not be appropriate to add an EPA registered feed through pesticide to a VFD feed if  
there is  information  suggesting that  the addition of the EPA registered  feed  through pesticide  
would interfere with  the  safety and/or efficacy of the  VFD feed.   In addition, feed through  
pesticides must be used according to their labeling and in compliance with EPA regulations, 
including the Tolerances and Exemptions for Pesticide Chemical Residues in Food 
requirements  in 40 CFR  part 180.  
 
You do not need to specify the inclusion of any feed through pesticide on the VFD.   However, 
there  is a  location for the veterinarian to write any  special instructions  on the VFD  (21 CFR 
558.6(b)(3)(xi)).   If the issuing veterinarian wants to recommend the inclusion of a feed through 
pesticide when authorizing the use of a VFD  feed, this may be included  in the special  
instructions  area of  the VFD.  
 
5.   Other than the required information, what other  information may I include in the  
VFD?  
 
As also noted in Question II.C.1  What specific information must the  veterinarian include on the  
VFD and what information is optional?  above, the veterinarian may, at his or her discretion, 
more specifically  identify the animals authorized  to be treated/fed the VFD feed (21 CFR  
558.6(b)(4)).  Specifically, the veterinarian can further  specify the location of the animals (e.g., 
site, pen, barn, stall, or  tank), the approximate age or weight range of the animals, or any other  
information the veterinarian deems appropriate  to identify the animals subject  to the  VFD.  
 
6.   How can I transmit an electronic VFD to the distributor immediately if my third-
party computer server holds all VFDs  and only transmits them  once per day (e.g., 
midnight)?  
 
For an immediate delivery of an electronic VFD  in this situation, we recommend that the 
veterinarian print  a copy of the VFD  and have it  hand delivered,  transmitted  by facsimile,  or  
scanned and  transmitted  electronically  to the distributor.  
 
7.   [Revised  2019] How do I cancel my VFD?  
 
To cancel a  paper VFD we recommend that  the  veterinarian promptly contact  the client and 
distributor in possession of a copy of the VFD  and notify them  of the cancellation.  
 
To cancel an electronic VFD that involves  a third-party  server, we recommend that the 
veterinarian  contact the server and request that the VFD not be transmitted.   If the veterinarian  
wants to cancel the VFD after the order has been electronically transmitted, we recommend that  
he or she  contact  the distributor and client who received a  copy of the VFD and  notify them of  
the cancellation.  
 
We recommend that  all  involved parties document the cancellation and  be prepared to  make all  
records available at the time of an inspection.   We also  recommend that  all involved parties  
document the final outcome of the cancellation  (e.g., state that the VFD feed was neither  
prepared nor  distributed to the client, or the client  did not receive or did not use any VFD feed).  
25   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
 
If the veterinarian wishes to cancel a VFD, but some animals have already started  consuming the  
VFD  feed, the veterinarian should work with the  client to ensure  those animals complete 
consumption  of the VFD feed in accordance with the VFD  unless the veterinarian determines 
under  their  medical judgment that continuation of treatment would not be in the best  interest of  
the animals  health.  
 
8.   In the past, I issued  paper VFDs.  Must all VFDs  be issued  electronically  now?  
 
No, issuing VFDs  electronically is optional. Paper VFDs  remain an acceptable means of  
authorizing the use of a VFD drug.  
 
9.   How do I obtain a VFD form  for a VFD drug?  
 
Although it  is not mandatory  for VFD drug sponsors to provide copies of VFD forms  specific to  
their products  for use by veterinarians, sponsors  may  make the VFD forms available to  
veterinarians in triplicate or  on a  website to enhance  efficiency and completeness of VFD  
transmissions.   Regardless of whether or not a drug sponsor  makes VFD  forms available to 
veterinarians, a veterinarian may create a  VFD form  for a VFD drug.  Any VFD  form, whether  
provided by the drug sponsor or created by a veterinarian, must include the information specified  
in 21 CFR 558.6(b)(3).  
 
10.   [Revised  2019] Can I  make my own VFD  form to authorize the use of a VFD drug?  
 
Although many companies distribute for use by veterinarians a VFD form that is specific to their  
products, a veterinarian  may also create or  use a  different VFD form  provided it contains all of  
the required information specified in 21 CFR 558.6(b)(3).   We have issued guidance on a 
common format for  VFDs which may be useful  if you choose to make your own VFD form.  See  
Guidance for Industry #233, Veterinary Feed Directive Common Format Questions and 
Answers.4  
 
11.   [Added 2019] If the VFD has expired for a batch of feed, can I reissue a VFD to  
use the remaining feed?  
 
Yes, VFD  feed  that  was distributed under  a VFD that has since expired  can be used under a new  
VFD so long as that use is in conformance with the VFD drug's approval and the VFD  
regulations.  For example, the  VFD feed may be  used for another group of animals under a new  
VFD,  so long as the VFD feed is consistent with the authorization on the  new VFD (e.g., correct  
drug level).  
 
12.   [Added 2019] I'm a veterinarian and I  also  want to  sell VFD feed.  What do I have 
to do?  
 
                                                 
4  
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM47 
4640.pdf  
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If you are  a  veterinarian and a  distributor, to distribute medicated feed you would need to follow  
the distributor requirements,  including sending a one-time notification to  FDA that you are a  
distributor.   As  a  distributor,  you would need to have on file either a VFD from  a  client or an 
acknowledgment letter,  if the client is also a distributor.   In addition, you would need to meet all  
of the requirements related to being a distributor  and distributing VFD  feed in 21 CFR 558.6.  
 
13.   [Added 2019] 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?  
 
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 21 CFR 530.3(i), 
the veterinarian must issue the VFD in  the context of a valid VCPR as defined in 21 CFR 
530.3(i) (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:  
https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm  
 
A veterinarian would need to meet these requirements for the State the animals are located  in, in  
order to  issue a lawful VFD.   This requirement is  typically met by the veterinarian having a  
license to practice veterinary medicine in the State.   However, in some  States a veterinarian may  
be able to practice veterinary medicine within  that  State even if  the veterinarian  is  licensed in 
another  State,  through reciprocity or a similar type of program.  
 
Because under both Federal and State VCPR  requirements,  veterinarians  must  be available to 
provide any necessary follow-up evaluation or care,  veterinarians  cannot write  a lawful VFD  
under a valid VCPR if  they  do not have permission to practice veterinary medicine for those  
animals during the entire duration of the VFD.   Therefore, the expiration date of the VFD should 
not exceed the length of  time  during which  the veterinarian is temporarily  authorized to  practice 
veterinary medicine  in the  state where the animals are located.  
 
14.   [Added 2019] 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?  
 
No, the client cannot decide when to stop feeding a VFD feed  when you authorize the VFD for  
the full 42 days.  The VFD authorizes the use of the VFD feed as required by 21 CFR  
558.6(a)(1).   Therefore, the use of the VFD  feed must conform to the information the  
veterinarian  authorizes on the VFD.  
 
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In situations where there is a range for the VFD, the veterinarian should use his or her  medical  
judgment to determine an appropriate  duration.   It is acceptable for the veterinarian  to indicate 
the approved range for the duration and then provide additional information in the special  
instructions, including when it is appropriate  to discontinue treatment.   Using the example  
provided, the veterinarian could write 21-42 days in the duration and write in the special  
instructions  Feeding may be discontinued after  21 days but  prior  to 42 days when no symptoms  
have been observed for [X] days.  
 
15.   [Added 2019] 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?  
 
Because the final rule  requires the  veterinarian  to write  the level of VFD  drug in the  VFD  feed 
and duration of  use  on the VFD  ( 558.6(b)(3)(x)), the VFD must  specify the drug(s) in terms  
of g/ton in feed.  The allowable  level of drug in the VFD feed is part of the VFD drug approval  
and is located on the VFD drug label.   Many non-FDA resources are available to  assist  
veterinarians in making any needed  calculations.   The veterinarian may work with the  distributor 
and/or client to determine an appropriate  level of VFD drug in the VFD feed.  The distributor  
and client often have additional information such as the nutritional formulation and consumption 
rate that may be necessary to determine an appropriate drug  level that is consistent with the 
approval.  
 
16.   [Added 2019] 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)?  
 
Yes, a veterinarian may instruct a client (producer) to hold animals beyond the labeled 
withdrawal  period for VFD drugs used in those animals.  The labeled withdrawal period is a  
minimum that needs  to be  met.   Therefore, it would be acceptable for a veterinarian to 
recommend an extended withdrawal period beyond the minimum required by the label if they 
deem it necessary.  
 
For purposes of writing  a lawful VFD, the VFD  rule requires the withdrawal time, special 
instructions, and cautionary statements necessary for use of the drug in conformance with the  
approval be  written on the VFD  (21 CFR 558.6(b)(3)(xi)).  Therefore, the withdrawal period that  
the veterinarian writes on the VFD must be the withdrawal  period that appears on the approved 
labeling for  the use being authorized.  However, the veterinarian may use the special  instructions  
area of the  VFD to provide the  client (producer)  with instructions for holding the animals for a  
longer time than the minimum  required by the label to help ensure that any food from  these  
animals is not adulterated.  
 
17.   [Added 2019] Can I work with a feed distributor, nutritionist, or other animal  
health professional  in order to write  a VFD?  
 
Yes, a  veterinarian may consult  with others  when preparing the VFD.   As stated in the VFD  final  
rule,  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) 
28   Contains Nonbinding Recommendations  
Draft   Not for  Implementation  
and (3)).  While  we encourage veterinarians  to work together  with the client, feed distributor, 
nutritionist,  or other animal health professionals  to gather the information necessary to write a  
complete and accurate VFD, 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.  
 
18.   [Added 2019] 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?  
 
Yes.   The approximate number of animals is the potential number of animals of the species and 
production class identified on the VFD that will be fed the VFD feed or combination VFD feed 
manufactured according to the VFD at the  specified premises by the expiration date of the VFD.  
 
The approximate number of animals should include  all animals that are being authorized for 
treatment from the current and successive groups of animals  on the premises prior to the  
expiration date.   The treatment of any animals with  VFD feed after the  expiration date would  
need to be authorized under a new VFD.  
 
19.   [Added 2019]  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?  
 
Durations of use may be  reflected in different ways in the  approval, conditional approval,  or  
index listing and on the corresponding labeling.   Some labels  do not  allow the veterinarian  any 
discretion in selecting a  duration of use.  For example, a label that states  feed for X  days  
indicates  that the VFD feed must be fed for the exact number of days specified on the  label and 
does not provide discretion for the veterinarian to authorize use for a different number of days.  
 
In contrast, some labels do allow the veterinarian some discretion in selecting a duration of use.  
For example, a label that states feed up to X days  indicates that the veterinarian  has some 
discretion in selecting any number of days up to day  X when writing the duration of use on the  
VFD.   The client  (producer)  is authorized  to use (feed) the medicated feed in compliance with  
the terms of  a lawful VFD that is issued by a licensed veterinarian, so when discretion  is 
allowed,  it is important that the veterinarian  writes  the VFD to reflect how long the client  should  
feed the animals the VFD feed.  
 
20.   [Added 2019] Our veterinary clinic  has multiple veterinarians.  Can any of our  
veterinarians write a VFD for any of our clients?  
 
The  Federal  VCPR  may apply to multiple veterinarians  involved in a group practice  so  it is 
permissible  for any of the veterinarians providing for the veterinary needs  of  an individual client  
or patient to write the  VFD,  so long as the  Federal VCPR definition is  met.   (See Comment 26, 
61 Fed. Reg. 57732 at 57738  (Nov.  7, 1996)).   If you are operating in a  State in which the  State 
VCPR requirement applies to the issuance of a VFD,  you should consult  your  State.  
 
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21.   [Added 2019] 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?  
 
The veterinarian is required to issue the VFD that is in compliance with the approved, 
conditionally approved, or indexed conditions for use (21 CFR 558.6(b)(2)).   Therefore, the VFD  
must contain the information in the  approval,  which is the  information for the Type  C  medicated  
feed that will be fed to the authorized animals.  
 
However, this does not  mean that the VFD  must be filled with a Type C medicated feed.   A VFD  
authorizes a client to  receive a Type B or Type C  medicated feed.   If a client receives  a Type B  
medicated feed, the client needs  to follow the appropriate mixing directions so that the resulting  
Type C  medicated feed conforms to  the VFD drug approval  and the VFD authorizing the use of  
the VFD feed.   FDAs Blue Bird Labels website has representative labeling with mixing 
instructions for Type B  medicated feeds.  
https://www.fda.gov/animalveterinary/products/animalfoodfeeds/medicatedfeed/bluebirdlabels/d 
efault.htm  
 
22.   [Added 2019] 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?  
 
Extralabel  use of drugs, including VFD drugs,  in or on animal feed is prohibited (21 U.S.C. 
360b(a)(4);  21 CFR 530.11(b)).  However,  we recognize  that there are limited approved, 
conditionally approved, or  indexed  drugs for use  in or on animal feed available for minor  
species.  In addition, some  minor species  cannot be practically medicated in any other way than 
through the  use of  medicated feed.  We  have  recently revised  Compliance Policy Guide (CPG) 
Sec.  615.115  Extralabel  Use of Medicated Feeds for Minor Species,  which  provides  direction to 
field investigators  to exercise enforcement discretion  for  the extralabel use of  medicated feeds in  
minor species  when certain conditions have been met.   The  revised CPG  provides  guidance to 
FDA  field personnel on when to exercise enforcement discretion for  the  extralabel use of both 
OTC and VFD drugs in medicated feed for minor species.  
 
See the link below for information on the revised CPG  Sec.  615.115 Extralabel Use of  
Medicated Feeds for Minor Species:  
https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm529164.htm.  
 
23.   [Added 2019] Do I need to have a  laboratory confirmation of  disease  prior to  
writing a  VFD?  
 
No, there is  not a requirement in the  VFD regulations  for laboratory analysis to confirm a  
diagnosis.  It is up to the veterinarian authorizing the VFD to determine the level of clinical  and 
diagnostic evidence necessary  to authorize the VFD.  
 
24.   [Added 2019] 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?  
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Yes, under certain circumstances.  For paper VFDs,  the veterinarian can  make changes to the 
original VFD at the time it is created by initialing and dating the corrections  in ink or another  
indelible (i.e.,  permanent) method provided that the original  information is not obscured.  Please 
note that we expect only  minor edits  (e.g., correcting the address, the expiration date, etc.)  could  
be made without  needing reissue  a new VFD.   For electronic VFDs,  simply correct the error 
electronically  prior  to issuing the VFD.  A new VFD would be necessary if these conditions  
cannot  be met.  
 
If the VFD  has already  been issued  (i.e.,  the copies have already been sent to the client and/or  
distributor),  we recommend you cancel the original incorrect  paper or electronic  VFD and issue a 
new corrected VFD.  If  you plan to cancel  the incorrect VFD, you should promptly contact  the  
client and distributor  in possession of a copy of the VFD and notify them of the cancellation.  
See Question  III.A.7. [Revised  2019]  How do I cancel my VFD?  
 
25.   [Added 2019] 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?  
 
No.  If a client requires  a new VFD before the first VFD expires, the  client must be issued a new  
VFD in accordance with the VFD regulation in 21 CFR 558.6.   This requires that  the new VFD 
include, among other  things, the veterinarians  signature,  the date of VFD issuance,  and the 
VFDs  expiration  date.   The date the veterinarian signs the VFD is the date of  VFD issuance, and  
the date of issuance is the basis for determining the expiration date as it signifies the date the 
VFD came to effect.  
 
B.   Distributor  
 
1.   [Added 2019]  Who is a  distributor?  
 
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, or  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 FDAs  VFD regulations  (21 CFR 
558.6(a) and  (c)), which are discussed below.  
 
2.   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  animal feed containing a VFD drug  
(21 CFR 558.6(c)(5)).  The notice  should be sent to FDA, Center for Veterinary  
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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 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));  
   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  
distributors acknowledgement letter for 2 years (21 CFR 558.6(c)(8)).  
 
3.   [Revised  2019] What is the Distributor Notification  Process?  
 
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  
distributors complete name and business address, the distributors  signature or the signature of  
the distributors authorized agent, and the date the notification was signed (21 CFR 558.6(c)(5)).  
 
In some cases, an animal producer (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 one-
time notification to FDA, the animal producer must supply either an acknowledgment letter  (see  
below  Question III.B.6. [Revised  2019] What  is an acknowledgment letter?  or a VFD for the  
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receipt of the Type B VFD feed from the distributor  (21 CFR 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  in accordance with  21 
CFR 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  (21 CFR 
558.6(c)(2) and (8)).  
 
4.   When is a distributor required  to submit an updated notification  to the FDA?  
 
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)).  
 
5.   Is there a publicly available VFD distributor notification  list?  
 
Yes, there  is a publicly available VFD distributor notifications  list.   The list is available at:  
https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/default.htm.  
 
6.   [Revised  2019] What is an  acknowledgment letter?  
 
An acknowledgement letter is  defined in FDAs 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)).  
 
7.   [Revised  2019] How is  an acknowledgment letter  different from  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)).  
 
The acknowledgment letter  is  a tool  used when a distributor is distributing VFD  feed to another  
distributor, instead of  to a client  (the  owner of the animals or other caretaker).  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 fill the VFD  promptly.  
 
8.   When is a medicated feed  mill license required?  
 
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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)).5   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.  
 
9.   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.   A list of Category II drugs  is located  in  21 CFR  558.4(d)).  
 
10.   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 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.  
 
11.   [Revised  2019] 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?  
 
No, a lawful VFD can only be used to authorize the use of a VFD drug, either alone,  or  in an 
approved combination VFD drug(s) that may  in some cases include one or  more OTC  animal 
drugs in addition to the  VFD drug(s).  See Question  II.C.13. [Revised  2019] What  additional  
information is required on a VFD authorizing the  use of a combination VFD drug?   If a  
distributor receives a VFD that specifies a drug other  than an approved, conditionally approved, 
or  indexed  VFD drug(s) or combination VFD drug(s), the  distributor may  not fill that  VFD.  
 
12.   [Added 2019] 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?  
 
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  that the VFD has been  
authorized under.   If the same person is doing both of these activities, then the person is not  
                                                 
5  https://www.ecfr.gov/cgi-bin/text-
idx?SID=b8e74620d2b65cd5c35fb00efa6dbcd9&mc=true&node=pt21.6.558&rgn=div5%20-%20se21.6.558_14  
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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 clients animals.  
 
13.   [Added 2019] Can a distributor distribute a VFD feed to a representative of the 
client (e.g., a family member, or employee)?  
 
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,  they 
should contact the client directly to  verify  the relationship.  
 
14.   [Added 2019] Can  an acknowledgment letter  be written to cover  multiple  
shipments of VFD feed?  
 
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.  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.  
 
15.   [Added 2019] 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?  
 
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In the described scenario, the person manufacturing the VFD feed and shipping it  to a  farmer is  
considered a distributor  because he/she is  distributing VFD  feed  to another person.  Any 
distributor  must send a  distributor notification to FDA and comply with the distributor  
requirements in 21 CFR 558.6, including maintaining a copy of the VFD.  
 
In the described scenario, the dealer  would not be a distributor as defined in 21 CFR 558.3 
because the dealer  is  not distributing the VFD feed to another  person,  even though the dealer  has  
a business  relationship with the  distributor  and the farmer.  As a result, there would not need to 
be an acknowledgment letter between the distributor and the  dealer.  A dealer does not have to 
submit a distributor notification to  FDA unless the  dealer  physically distributes  VFD feed.  
 
However, the dealer  must  retain a  copy of the VFD, because the dealer  is  also involved in the  
distribution and use of the VFD  feed.   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))).  
 
16.   [Added 2019] What is needed in a distributor notification and can a distributor  
notification  cover multiple locations?  
 
The VFD distributor notification letter can be done in a  number of ways,  so  long as it contains  
the following required information:  
   The distributors complete name and business address;  
   The distributors  signature or the signature of the distributors authorized  agent; and  
   The date the notification was signed.  
 
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), 7519 
Standish Place, Rockville, MD 20855, FAX: 240-453-6882.   (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.  
 
17.   [Added 2019] What is needed in an acknowledgment letter  and can an  
acknowledgment letter cover multiple locations between the distributors?  
 
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:  
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   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.  
 
18.   [Added 2019] Do I need to hold VFD drugs or feed in a  secure  or locked area?  
 
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).  
 
19.   [Added 2019] 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?  
 
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  distributor 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  
CGMPs (21 CFR part 225), as well  as the CGMPs for animal food (21 CFR  part 507).   In 
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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 States 
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.   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 must either discard  
the remaining VFD  feed once the VFD expires, or obtain a new VFD from the veterinarian to 
authorize use of the  remaining feed for the full  course of  treatment before the new VFD expires.  
 
20.   [Added 2019] I am a distributor with  multiple  locations.  Can  I fill a VFD from any  
of  my locations?  
 
One distributor may have multiple locations (all under the same corporate ownership) and, 
provided the  distributor has already  sent FDA a letter indicating its intent to distribute  VFD  feed  
at each of these locations,  it is acceptable for that distributor to fill a VFD from any of  its  
locations.  However, it  is the distributors responsibility to comply with the applicable 
requirements in 21 CFR 558.6(a) and (c), including the requirement to distribute a VFD  feed  
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.  
 
In addition, if  the distributor manufactures  the VFD feed, the distributor  must also keep 
manufacturing records  as required under 21 CFR  part 225.   During an inspection,  we  intend to  
review VFDs  and compare them to manufacturing records.   We would expect that the amount  of 
medicated feed produced to fill  a 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.  
 
21.   [Added 2019] I am a distributor with  multiple  locations.  Do I need a VFD or  
acknowledgment letter  to transfer VFD feed between  my locations?  
 
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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.  
 
For more information on who is a distributor and when a distributor  is distributing to another  
person  please see Question III.B.1. [Added  2019] Who is  a distributor?  
 
For more information about what is required  in an acknowledgment letter, please see Question 
III.B.6. [Revised  2019]  What is an acknowledgment letter?  
 
22.   [Added 2019] Can I provide a client with nutritionally different diets over the  
duration of use for a VFD?  
 
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.  
 
23.   [Added 2019] 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?  
 
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  
(producer)  are expected to 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.  
 
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24.   [Added 2019] 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?  
 
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 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 feed from a Type  
A  medicated article  that falls  into Category II.  (21 CFR 558.4).  Therefore, Type A  medicated  
articles in Category  II must  not be distributed  to  a client that  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).   
See Question  III.B.8. When is a medicated  feed  mill license required?  
 
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).  
 
25.   [Added 2019] 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?  
 
As stated  in  the preamble to the 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).  Feed mills 
should retain the necessary records  to document  the amount of feed that was  manufactured and 
distributed under the VFD  and make such records 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, feed mills  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  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  
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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  feed  mill  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.  
 
26.   [Added 2019] Can I  manufacture  VFD  feed to have on hand before  a client comes 
in with a VFD?  
 
Yes.   VFD distributors  may be aware of VFD  medicated 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 medicated  feed  in accordance with  the 
VFD drug approval, provided they do not distribute the VFD  medicated  feed until presented with  
either a lawful  VFD  from a  client or the clients veterinarian,  or an acknowledgement letter  from 
another distributor.  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.  
 
C.   Client  
 
1.   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));  
   not  feed a VFD feed or combination  VFD  feed to animals after  the expiration date on the  
VFD (21 CFR 558.6(a)(2));  
   provide a  copy of the VFD to the  distributor when requested to do so by the issuing 
veterinarian  (21CFR 558.6(b)(8));  
   maintain a copy of the VFD for a  minimum of 2 years (21 CFR 558.6(a)(4)); and  
   make  the  VFD available  for inspection and copying by FDA upon request (21 CFR  
558.6(a)(5)).  
 
2.   What is my  role as  a client in the veterinarian-client-patient-relationship (VCPR)?  
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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.  One such  requirement  is  that the veterinarian must  
issue the VFD in the context of a State-defined VCPR or,  if the VCPR requirements as defined  
by such State do not include the key elements of the  Federally-defined valid VCPR  or are not  
applicable to the issuance of a VFD, then the veterinarian must issue the VFD in the context of  a  
valid VCPR as that term  is defined  in FDAs regulations at  21 CFR 530.3(i).  (21 CFR 
558.6(b)(1)(ii)).  In cases where the  Federally-defined VCPR  applies, in order for the  VFD to be  
written in the context of a valid  VCPR you, as the  client,  must agree to follow  instructions of the  
veterinarian (21 CFR 530.3(i)(1)).  In cases where a veterinarian is issuing  the VFD in the  
context of  a State-defined VCPR, as  a client you must follow the client  requirements in the  State-
defined VCPR.  
 
3.   [Revised  2019] Can  I have my veterinarian write a VFD to authorize the use of a 
medicated feed that is not approved for the use Im intending (i.e., extralabel use)?  
 
No, a  veterinarian may only write a  VFD to authorize  use of  a VFD drug or combination VFD  
drug in feed  for the approved, conditionally approved, or indexed conditions of use.  Use of VFD  
feed in an extralabel manner is prohibited.  21 CFR 558.6(a)(3).  However, if you raise a minor  
species and there is no  approved use for that species, see Question III.A.22. [Added 2019] 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?  
 
4.   Can I feed  my animals a VFD feed  after  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)).   A  client may use the VFD to obtain VFD feed any time prior  to 
the  VFDs  expiration, but the client  may not feed that feed to animals after the VFD expires.   For  
some drugs,  there  are discrete expiration and duration of use time periods  specified as part of  the  
drug approval which make it easier to determine in advance  whether treatment would be  
completed  by the  VFDs  expiration date.   The client is  responsible for feeding the VFD  feed  in 
compliance with the terms of the VFD,  which means completing the authorized  course of  
treatment  by the expiration date.   If a VFD  will expire prior  to the completion of a course of  
treatment, the client must  either discard the remaining VFD feed once the  VFD expires, or  obtain 
a new VFD  from the veterinarian to authorize use  of the  remaining feed for the full  course of  
treatment before  the new VFD  expires.  
 
5.   I  have a VFD that I would like to use to feed a VFD feed, but the  VFD  will expire  
before I can complete the duration of use on the  VFD.   What should I do?  
 
In cases where a client would like to use a VFD feed but cannot complete the duration of use on 
the  VFD  before the  VFD  expires, the  client should contact  the veterinarian to request a new  
VFD.  A VFD feed or combination VFD feed must not be fed to animals after the expiration date  
on the VFD (21 CFR 558.6(a)(2)).  
 
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6.   [Added 2019] Do I have to use the same distributor to obtain  all of  the  VFD feed  
on a  VFD?  
 
In general, only one  distributor  (e.g., feed mill) should  receive and fill a  VFD.  
 
The VFD regulation requires  a veterinarian  to send a copy of the VFD to the distributor via  
hardcopy, facsimile (fax), or electronically.   If  in hardcopy,  the veterinarian must send the copy 
of the VFD to the distributor either directly or through the client. (558.6(b)(8)).   If the  
veterinarian provides the  client  with a  hardcopy to take  to the  distributor, the  client can  choose  
which distributor  to use.  
 
When the veterinarian is  issuing the  VFD directly to the distributor  (i.e., the client  will not  be  
taking a hardcopy to the distributor), the client should tell the  veterinarian  to which distributor 
the  VFD  should be sent.   If the client  is unsure of  which distributor  should receive the  VFD, the  
client  should get a hardcopy from the veterinarian to  provide to the clients  distributor of  choice.   
If the veterinarian has sent the VFD to a distributor and  the client decides to get the VFD feed  
from a different distributor, the client  should ask  the veterinarian to revoke the VFD from the  
original distributor and resend it to the new distributor.  
 
In special circumstances, such as when  a mill runs out of a VFD drug and the client needs VFD  
feed immediately to adhere to the treatment regimen, there may be a need for two distributors  to 
fill the  entire order.   If that is the case,  the client and distributors should all keep records  
documenting the situation so that  it  is clear  that  the animals received only the treatment  
authorized by the VFD.  
 
7.   [Added 2019] 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 VFDs duration  and another mill will  
provide the  ration for animals during the last 10 days of  the VFDs duration.  
 
In situations where it has been predetermined that the VFD feed will come from two  different 
distributors  during the VFDs  duration  of use,  the veterinarian should indicate in the special  
instructions  area of the VFD  who the distributor  of the VFD  feed will be  for each portion of the  
treatment period.  Both distributors should receive copies of the VFD.  Each distributor should 
provide  only the  amount of feed that is commensurate with the approximate number of  animals  
and the portion of the treatment period for which the distributor is responsible for distributing the  
VFD feed.  
 
8.   [Added 2019] 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?  
 
Yes.  The VFD does not include  information about the nutritional  ingredients in the ration of the  
VFD feed, so  it  is acceptable to feed  several rations under a single VFD  provided that  each of  
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those rations  is  manufactured in a way that is  consistent with  the drug approval and used in 
accordance with  terms of  the VFD.  
 
9.   [Added 2019] 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?  
 
A veterinarian cannot  issue a VFD that authorizes a duration of use that is inconsistent with the 
directions for use described  on the  approved product labeling.   In the example provided, the  
approval limits the treatment to 5 days  and therefore  the VFD can only authorize that approved 
duration.   Issuing a VFD that authorizes  a 5-day  course to be repeated for  the same animals 
would be considered an illegal extralabel use.  
 
However, if the veterinarian reassesses the animals involved after a single course of therapy (i.e.,  
after the drug  was administered according to the labeled dose  and duration), the veterinarian may 
decide  that additional therapy is warranted.   In such case, a new VFD  would be  needed.  
 
The veterinarian should report  to FDA any  treatments that were not  clinically  effective or any  
adverse reactions that may have occurred within 10 days of  their  occurrence.  For instructions on 
reporting such information, visit  FDAs webpage entitled How to Report Animal Drug Side  
Effects and Product Problems at:  
https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm.  
 
10.   [Added 2019] 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?  
 
Yes, but the  new owner may need to get a new VFD to continue treatment.   In some situations,  
ownership of  the  animals changes  but the animals continue to  be fed by the same caretaker.  
Where this is the case, provided the caretaker  is the client for  the purposes of the VCPR  
requirements,  the VFD would still be valid.   However, if the ownership transfer results in a new  
client for the purposes of the VCPR,  the new client would need a new VFD for the transferred  
animals.  Only a  veterinarian  that has a VCPR  with the  new owner  (i.e.,  the new client)  and the  
transferred animals could write  the new VFD.  
 
In many situations, the transfer of ownership during a certain life stage of the animal may be  
expected.   For example, oftentimes one owner may raise a group of animals to a certain age or  
weight and then sell that  group to another owner  who will continue  to raise them. It is very  
important during a  transfer of ownership that the veterinarians and clients are  communicating 
and working together to avoid any unlawful use of the VFD  feed.  
 
For example, the veterinarian and original client should discuss the implications of a planned 
transfer of  ownership at the  time  the veterinarian is issuing the VFD to ensure that the authorized 
course of treatment can be completed prior  to the  planned transfer of ownership.   The original 
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client should also make the new client (purchaser) aware of any VFD  feed that  already  has been  
fed to the animals, including information about  the indication, dosage, and duration of use.  
 
To ensure the animals will receive  a complete treatment, it is preferable not to transfer ownership  
during a  time when VFD feed is being fed for a specific duration of use.   If a transfer of 
ownership needs to be made  while  animals are being fed under a VFD, coordination between the  
original owner and veterinarian,  and the new owner and  veterinarian is important.   The new  
veterinarian should issue a new VFD  according to the approval  but may use the special  
instructions  area of the VFD  to acknowledge the ownership transfer  and record how much time  
remains to complete the  treatment under the duration of  use, taking into consideration how long 
the animals  received treatment under the VFD held by the previous owner.  
 
11.   [Added 2019] Does the VFD  feed authorized by a VFD need to be shipped in one  
load, or can it be delivered in multiple loads?  
 
A  VFD feed  may be  manufactured and shipped in one load, or multiple loads.  This provides  
flexibility  for the VFD feed to be  manufactured and distributed in a way that meets  the  
nutritional needs of the animals, the manufacturing capacity of the  feed distributor, and the  
storage capacity of the client.  However, the  amount of feed manufactured and distributed should 
be appropriate  for the approximate number of animals authorized  to be fed under  the VFD  and 
can only be  used up  to the  VFDs  expiration date  unless the client obtains another VFD  
authorizing the use of the remaining VFD  feed.  
 
12.   [Added 2019] 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?  
 
Yes, you can get VFD  medicated  feed from  Canada.  However, medicated feeds coming into the  
U.S.  must comply with U.S.  requirements.  If the medicated feed is a VFD feed, it must comply  
with the  requirements  in the VFD final rule.   This  means, for example, that the veterinarian  
authorizing the use of  the VFD  feed must have a  valid VCPR with the client  and  the clients 
animals, and must be licensed in the  State where the animals are being raised and fed.   In 
addition, the  medicated feeds must be manufactured and labeled in conformance with U.S.  
requirements   including being labeled  for the U.S.  market.  
 
13.   [Added 2019] 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?  
 
Yes, when the veterinarian selects an  affirmation of intent statement  that allows for the use of the  
VFD drug in combination with OTC  drugs, either  in a specific approved combination, or  in any 
approved combination,  the  producer may also  use the VFD drug alone.  In the  preamble  to the  
VFD proposed rule, after describing the three affirmation of intent options, we stated  that In all 
cases, the VFD  may be used to authorize the distribution and use of  medicated feed containing  
the VFD drug alone.  (78 FR 75515 at 75521).  
 
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14.   [Added 2019] I want to get a Type A  medicated article and manufacture  my own 
feed.   What are the requirements?  
 
Type A  medicated articles for VFD  drugs are not considered  VFD  feeds.   Therefore, a VFD is 
not required  to obtain a Type A  medicated article from a distributor.   However, the FD&C Act  
requires  a VFD for the distribution and use of any VFD  feed resulting from the Type A  
medicated article.   (Section 504(a)(3) of the FD&C Act (21 U.S.C 354(a)(3))).   Therefore,  you 
must have a  VFD prior to distributing or using  the VFD feed  manufactured with  the VFD Type  
A  medicated article.  
 
A  medicated feed mill license is  required if the VFD drug used to manufacture  a Type B or Type  
C  medicated feed is a Category II, Type A  medicated article (21 CFR 558.4(a)).   A list of 
Category II drugs  is located at  21 CFR 558.4(d).6   See Question  III.B.8. When is a medicated 
feed mill license required?  
 
In addition, any person  who is manufacturing, processing, packing, or holding medicated feed 
must do so in compliance with the applicable CGMP requirements for  medicated feeds,  which 
are  found in 21  CFR  part 225.  
 
15.   [Added 2019] 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?  
 
Three parties, the  veterinarian, producer (client), and the VFD feed distributor, are required to 
keep the  record of a VFD  (21 CFR  558.6(a)(4)).   In cases of  on-farm  milling, where a  VFD feed  
distributor was not involved in  the original transaction, only  the veterinarian and the client would  
need to maintain copies  of the VFD  since  there  would not be a need for  a  VFD distributor copy.  
 
16.   [Added  2019] 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?  
 
Yes.   If a client  decides to source VFD feed from another distributor prior to the expiration date  
of the existing VFD, then:  
 
(1)   the existing  VFD  will need to be cancelled with the current distributor as  
described in  Question  III.A.7. [Revised  2019]  How do I cancel my VFD?, and  
(2)   a new VFD  will need to be issued and sent to the  second distributor.  
 
All parties, including the veterinarian, client, and the first distributor, should document  the  
situation  to explain why the cancellation occurred.   The veterinarian authorizing the new VFD  
will need to consider  any changes in the approximate number of animals left to be fed the VFD  
feed under the new distributor.  Switching from  one distributor to another after distribution of  
VFD  feed is expected  to  be a rare occurrence.  
                                                 
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17.   [Added 2019] I am a client.  Do I need to keep any records  describing my use of  
the VFD feed  in addition to keeping the VFD?  
 
Under the VFD final rule, clients are only required to keep a copy of  the VFD  itself.  However, it 
may be important for  clients, particularly those  who raise food-producing animals, to  keep 
additional records  to help ensure that  the VFD feed was used  in accordance with the VFD and  
any  food  made from the treated animals  will be safe.   For  example, a producer may  want  to 
record  information such as the date the VFD feed was received,  when the VFD feed was  used, 
and which animals received the VFD feed  to document that  the  VFD feed was fed in accordance 
with the VFD.   While this documentation is  not required by the  VFD regulation, it  would  be  
helpful for a producer  to have  such information available during an inspection to demonstrate  
whether a particular VFD was actually used  and, if so,  how the VFD feed was used.  
 
In addition, where a VFD  that  has been  issued  to a client is subsequently cancelled, either  at the 
clients request or for other reasons,  we recommend that  the client keep  records documenting the 
cancellation  as described in  Questions III.A.7. [Revised  2019]  How do I cancel my VFD?  and 
III.C.16. [Added 2019]  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?, above.  
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