This presentation was prepared for the 2016 American Agriculture Law Association Annual Educational Symposium. This presentation will be given on October 6, 2016. It first lays the background of the Veterinary Feed Directive ("VFD") and then delves into the requirements of various stakeholders including (1) veterinarians, (2) livestock producers, (3) feed distributors, and (4) drug manufacturers.
1. Overview of the Veterinary
Feed Directive (“VFD”)
American Agriculture Law Association (“AALA”) Annual
Educational Symposium
October 6, 2016
Oklahoma City, OK
By Cari B. Rincker, Esq.
2. Who I Am
• Grew up on a beef cattle
farm in Illinois
– Advanced degrees in
animal science
• Past-Chair of the ABA,
General Practice, Solo &
Small Firm Division’s
Agriculture Law
Committee
• Client bases ranges from
livestock producers & food
entrepreneurs to mid-size
agri-businesses
5. Definitions
Antibiotic
• Can inhibit the growth of bad bacteria that cause infections
and illness.
• Antibiotics belong to a class of drugs called “antimicrobials.”
Antimicrobial
• Any substance of natural, semisynthetic or synthetic origin
that kills or inhibits the growth of microorganisms but
causes little or no damage to the host
• All antibiotics are antimicrobials, but not all antimicrobials
are antibiotics
6. The Players
U.S. Department of Agriculture (“USDA”) regulates antibiotics in meat,
poultry, and eggs via two sub-agencies.
• Food Safety Inspection Service (“FSIS”) (Primarily)
• Agriculture Marketing Service (“AMS”)
• Animal and Plant Health Inspection Service (“APHIS”)
Food & Drug Administration is an agency of the Department of Health and
Human Services (“HHS”).
• FDA regulates food and drugs in livestock animals excluding meat, poultry, and eggs (regulated by
USDA).
• Center for Veterinary Medicine (“CVM”) is a sub-agency which oversees the safety and effectiveness
of animal drugs and the approval process.
Centers for Disease Control and Prevention (“CDC”) is also under the HHS
umbrella and safeguards health by monitoring antibiotic resistance.
• National Antimicrobial Residence Monitoring System (“NARMS”) is a sub-agency of the CDC
composed of the FDA, CDC, USDA’s FSIS.
7. Approval of Antibiotics
FDA Must Approve Antibiotics
• Federal Food, Drug, and Cosmetic
Act (“FFDCA” or “FDCA”) prohibits an
animal drug to be sold into interstate
commerce unless is has been
approved by an Approved New
Animal Drug Application (“NADA”).
• FDA does approve the use of
antibiotics in livestock and must
approve all antibiotics (for humans,
animals, and livestock). See 21 CFR §
530.
• This requirement still exists with VFD.
8. Background
Prior to 1996, FDA had 2 options
for distributing animal drugs:
• Over-the-Counter (“OFC”)
• Prescription (Rx)
Federal Food, Drug and Cosmetic
Act (“FDCA”) didn’t require
prescriptions for animal feeds.
• Viewed as being impractical because
feed mills would need to have a
pharmacist onsite to dispense
prescription drugs; thus feeds were OTC.
9. Background
Statutory
History
• In 1996, Congress enacted the Animal Drug
Availability Act (“ADAA”) to facilitate the approval
and marketing of new animal drugs and
medicated fees.
• This law created a new regulatory category for
animal drugs used in animal feed – veterinary
feed directive (“VFD”) drugs.
• First VFD Rule by Food & Drug Administration
(“FDA”) was published in the Code of Federal
Regulations in 2000.
• The Second VFD Rule was published on June 3,
2015
10. Background
Under ADAA, VFD drugs are new
animal drugs intended for use in or
on animal feed, which are limited by
an approved application,
conditionally approved application
or index listing to use under
professional supervision of a
licensed veterinarian.
• VFD drug requires a VFD document by
licensed veterinarian who authorizes the use.
• Although a similar concept, VFD drugs are not
prescription (Rx) drugs
11. Background
A VFD is a written statement issued by
a licensed veterinarian in the court of a
the veterinarian’s professional practice
that orders the use of a VFD drug or
combination VFD drug in an animal feed.
•This authorizes the livestock producer to obtain
and use animal feed bearing or containing a VFD
drug or combination VFD drug to treat the
producer’s livestock in accordance with the
approved, conditionally approved application or
index.
12. Background
Currently there are a few VFD
drugs (mostly OTC).
• FDA received responses saying that the
VFD process was overly burdensome.
• FDA also received public comment
about public health, use of
antimicrobials/antibiotics in meat
producing animals, and concern for
antibiotic residence.
• New VFD “responded” to these
concerns.
13. Background
The final rule on VFD is the third of
three core documents that the FDA is
using on its judicious use policy for
antibiotics.
Publication 1: Guidance for the
Industry (GFI) #209 “The Judicious
Use of Medically Important
Antimicrobial Drugs in Food
Producing Animals”
Publication 2: Guidance for the
Industry GFI #213 “New Animal Drugs
and New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors
for Voluntarily Aligning Product Use
Conditions with GFI #209”
14. Background
• Published around April 2012
• Described the overall policy direction.
• This publication focused on 2 key
principles:
• Limit use of medically important
antimicropial drugs in food-producing
animals to those uses (1) considered
necessary for assuring animal health and
(2) that include veterinary oversight or
consultation
Publication 1:
Guidance for the
Industry (GFI)
#209 “The
Judicious Use of
Medically
Important
Antimicrobial
Drugs in Food
Producing
Animals”
15. Background
•Published in December 2013
•Outlined a detailed process and timeline for implementing the
measures identified in GFI #209.
•This document discussed the transition of OTC antimicrobial
drugs to VFD marketing status.
•This publication noted that December 2016 was the target for
drug sponsors to implement changes to use conditions of
“medically important” antimicrobials in food and water to:
•(1) voluntarily withdraw approved production uses such as
“increased rate of weight gain” or feed efficiency and
•(2) after the label changes these production uses will no
longer be legal; however, therapeutic uses are to be retained
for treatment, control and prevention indications.
Publication 2: Guidance
for the Industry GFI #213
“New Animal Drugs and
New Animal Drug
Combination Products
Administered in or on
Medicated Feed or
Drinking Water of Food-
Producing Animals:
Recommendations for
Drug Sponsors for
Voluntarily Aligning
Product Use Conditions
with GFI #209”
16. Background
• A key principle noted in this publication was to
include a veterinarian in the decision-making
process.
• It doesn’t require direct veterinarian
involvement in the drug administration but it
does require use to be authorized by a licensed
veterinarian in the context of a VCPR.
• This includes water soluable products to Rx
(“medicated drinking water”) and products
used in or on feed to VFD (“medicated feed”)
Publication 2: Guidance
for the Industry GFI #213
“New Animal Drugs and
New Animal Drug
Combination Products
Administered in or on
Medicated Feed or
Drinking Water of Food-
Producing Animals:
Recommendations for
Drug Sponsors for
Voluntarily Aligning
Product Use Conditions
with GFI #209”
17. Background
VFD – final rule
published in the Federal
Register on June 3, 2015
Builds off of GFI #213
(“Publication 2”)
Provides for a phased
enforcement of the
implementation of the
rule as OTC become VFD
FDA focusing now on
stakeholder education
• Veterinarians
• Livestock producers
• Feed mill distributors
18. Background – Effective Date
First VFD Rule
(December 8,
2000) was in
effect until
October 1,
2015
Second VFD
Rule (June 2,
2015) went
into effect
after October
1, 2015
19. Background
What drugs are
affected? (Look
for 2 things)
Those that are
considered
“medically
important” AND
Administered in feed
or drinking water
• i.e., injectables, boluses
and other dosage forms
are not affected
(GFI # 213)
20. Background
So what are
“medically important”
antimicrobials?
• GFI #213 defined “medically
important” to include all antimicrobial
drugs/drug classes that are listed in
Appendix A of FDA’s Guidance #152
• Put simply, it includes all antimicrobial
drugs that are considered important by
the FDA for therapeutic uses
21. Background:
Affected Antimicrobials Administered via Feed
Antimicrobial Class Specific Drugs Approved for Use in Feed
Aminoglycosides Apramycin, Hypgromycin B, Neomyscin, Streptomyscin
Diaminophyrimidines Ormetoprim
Lincosamides Lincomycin
Macrolides Erythromycin, Oleandomycin, Tylosin
Penicillins Penicillin
Streptogramins Virginiamycin
Sulfas Sulfadimethoxine, Sulfamerazine, Sulfamethazine,
Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline
See FDA “Medically Important
Antimicrobials in Animal Agriculture” at 15
22. Background:
Affected Antimicrobials Administered via Water
Antimicrobial Class Specific Drugs Approved for Use in Water
Aminoglycosides Apramycin, Gentamicin, Neomyscin, Spectinomycin,
Streptomyscin
Diaminophyrimidines NONE
Lincosamides Lincomycin
Macrolides Erythromycin, Oleandomycin, Tylosin
Penicillins Penicillin
Streptogramins NONE
Sulfas Sulfachlorophyrazine, Sulfachlorpyridazine,
Sulfadimethozine, Sulfamerazine, Sulfamethazine,
Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline, Tetracycline
See FDA “Medically Important
Antimicrobials in Animal Agriculture” at 16
23. Background
What drugs
aren’t affected?
• Antimicrobials that are already VFD
• Avilamycin, florfenicol, tilmicosin
• Rx Tylosin
• Antimicrobials that are not “medically important”
• Ionophores (e.g., monensin, lasalocid)
• Bacitracin (e.g., bacitracin zinc)
• Bambermycins
• Carbodox
• Non-antimicrobial drugs
• Anthelmentics
• Beta agonists
• Coccidiostats
See FDA “Medically Important
Antimicrobials in Animal Agriculture” at 17
24. Background
Feed-use drugs are assigned to one of two
categories
•Category I – Drugs having the lowest potential for
residues
•Category II- Drugs having the highest potential for
residues
•VFD drugs are no longer automatically Category II
This category determines whether a facility
needs to be licensed to handle the drug in
the Type A form
27. Veterinary Requirements
Must be in compliance with the state’s veterinarian-client-
patient relations (“VCPR”) requirements pursuant to
§ 530.3(i)
If state doesn’t require a VCPR then FDA now requires that
the VFD be issued within context of Federally defined VCPR,
which requires:
• Engage with livestock producer and assume responsibility for making
medical judgment about the animal’s health.
• Have sufficient knowledge of the animal by virtue of examination and/or
visit the facility where the animal is managed to initiate a preliminary
diagnosis.
• Provide for any necessary follow-up evaluation or care.
21 § CFR 558.6(b)
28. Veterinary Requirements
The veterinarian must
also provide a written
veterinary feed
directive (“VFD”).
The VFD must be in
compliance with the
conditions for approved
use, conditionally
approved use or indexed
use under the ADAA.
21 CFR 558.6(a)
29. Veterinary Requirements
Extra-labeling Use is not
permitted
• I.e., Use of feed containing a VFD
drug in a manner other than as
directed on the label is not
permitted.
21 C.F.R. 558.6(a)
31. Veterinary Requirements
• Vet’s and livestock producer/client’s
• Name
• Address
• Telephone number
• Premises at which the animals are
located
• Date of VFD issuance
• Species and production class of animals
to be fed the VFD feed
Required
Information
32. Veterinary Requirements
VFD must include the name
of the VFD drug
• could be the generic name
• can state that a substitution drug
is or isn’t allowed (optional info)
• if substitution is allowed then the
feed distributor may choose to
substitute if the generic VFD is
part of an approved combination
21 CFR 558.6(b)
33. Veterinary Requirements
VFD must include an
expiration date
• The vet can write a date up to 6
months from the date the VFD
is initiated.
• Duration determines the length
of time the VFD is allowed to be
fed to the animals as specified
on the product label.
34. Veterinary Requirements
VFD Must Include
• Approximate/potential number of animals to be fed by the expiration
date of the VFD on a premises
• Also needs the expiration date
• Indication for which the VFD is issued
• Drug level
• Duration of use
• Note: Duration is different than expiration date
• Withdrawal time
• Special instructions/cautions
• Number of reorders (refills) authorized – if permitted by the drug
approval
35. Veterinary Requirements
Note that expiration date and the duration of use are
2 different concepts
Few examples:
• Avilamycin has an expiration date of 90 days but should only be
used for 21 days
• Florfenicol for wine has an expiration date of 90 days but has a
typical duration of only 5 days
• Tilmicosin for cattle has an expiration date of 45 days but typically
prescribed for 14 days
37. Veterinary Requirements
VFD must include:
• An affirmation of
intent for
combination VFD
drugs
• Veterinarian’s
electronic or written
signature
38. Veterinary Requirements
Affirming
Intent on
the VFD
Choice 1: “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 drugs
in combination with any other animal drugs.”
Choice 2: “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 specifics ______________________
______________________________________________________]
Choice 3: “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.”
39. Veterinary Requirements
VFD must include premises ID but
may include more information of
the animals
• This is so someone can locate the animals,
if needed.
• May include specific information, such as
the pen or description of where the
animals are currently located.
• If the VFD is intended to authorize the use
of a VFD feed in a group of animals that are
located at more than one physical location,
then the VFD can specify more than one
pen so long as the feed is supplied by a
single feed distributor.
40. Veterinarian Requirements
VFD may provide the
following additional
information:
• Approximate age/weight
range of the animals
• Any other information the
veterinarian deems
appropriate to identify the
animals specified in the VFD
41. Veterinary Requirements
Please note that the VFD
no longer requires the
veterinarian to state the
amount of feed to be fed
to the animals
• Instead, the burden is on the
distributor to determine the
proper amount of feed to
manufacture and distribute to the
producer
42. Veterinary Requirements
Importantly, is not a
required VFD Form
• Guidance for the Industry
(“GFI”) #233 lists several
recommended common
formats for the VFD
• Veterinarian can create
his/her own VFD form but
should have it reviewed by
an attorney for compliance
43. Veterinarian Requirements
Copy of the VFD must go to the
client (producer) and feed
distributor
• Can be delivered hard-copy, facsimile or
electronic (e.g., email)
• Transmitted to the distributor and client gets
copy
Must maintain VFD records for 2
years
• Must retain original VFD
• Other segments can keep copies but VFD
must keep original
21 C.F.R. 558.6(a)
44. Producer Requirements
Feed animal feed containing a VFD
drug only to animals based upon a
duly issued VFD from a licensed
veterinarian
Maintain all VFD records for 2
years
• Keep copy in original form (hard copy v.
original)
• Must be available for inspection and
copying by FDA upon request
21 CFR 558.6(a)
45. Producer Requirements
Prohibited from feeding a
VFD after an expiration date
• The expiration defines the period
of time for which the authorization
to provide an animal feed
containing a VFD drug is lawful.
• Expiration date specifies the last
day the VFD feed can be fed to a
group of animals.
46. Producer Requirements
Veterinary Feed Directive Issuance
VFD
should
state the
expiration
date
Feed Delivery
Medicated
feed being
delivered
in different
increments
Feeding
Expiration
Date
21 CFR 558.6(a)
Note: Was the duration prescribed different
than the expiration date?
47. Who is a Feed “Distributor”?
Any person who distributes
a medicated feed containing
a VFD drug to either:
• Another distributor or
• Client-recipient of VFD
(livestock producer).
48. Feed Distributor Requirements
Shall only provide a VFD feed if the VFD
contains all the required information
and conforms to product approval
Maintain records for 2 years
• Keep copy in original form (hard copy v. original).
• Must be available for inspection and copying by
FDA upon request.
• Note that manufacturing records only need to be
kept for 1 year under 21 CFR Part 225 if
distributor also manufacturers.
21 CFR 558.6(c)
49. Feed Distributor Requirements
Provide one-time notifications
• To the FDA of the distribution of VFD
feeds stating that it intends to
handle/distribute VFD drug-
containing medicated feeds
• Acknowledgment of distribution
limitations for VFD fees that the
purchasers will sell the VFD feeds only
to producers with valid VFD orders or
to other distributors for whom they
have acknowledgement notices
50. Feed Distributor Requirements
Notification must include:
• Distributor’s name and business address
• Distributor’s signature (or agent’s signature)
• Date the notification was signed
Must notify FDA within 30 days of any change in
ownership or business info
• Must send notification to FDA, Center of Veterinary
Medicine, Division of Animal Feeds
51. Feed Distributor Requirements
If the distributor is distributing the
VFD feed to another distributor, then
an acknowledgement letter must be
sent from the receiving distributor
under 21 CFR 558.3(b)(11) before
shipment of feed.
Consigner distributor
must retain copy of
acknowledgement
letter for 2 years.
52. Drug Manufacturers
All labeling and advertising for (combination) VFD drugs,
feeds containing (combination) VFD drugs must have 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)
53. Drug Manufacturers
Substitution of Drugs
• If the VFD doesn’t specify that a generic version
may be substitute then the then the
manufacturer may use an approved generic
VFD drug to manufacture the VFD feed
• However, the manufacturer may not substitute
a generic VFD drug for a pioneer VFD drug in a
combination VFD feed if the generic VFD drug is
not part of an approved combination VFD drug
55. Effective Date Clarification
This second VFD rule
became effective on
October 1, 2015
December 2016 is the
target for drug
sponsors to implement
changes to use
conditions of products
January 1, 2017 target
for switching OTC drugs
to VFD
56. Oh, P.S. – I Wrote a Book
Cari B. Rincker & Patrick B.
Dillon, “Field Manual: Legal
Guide for New York Farmers
& Food Entrepreneurs”
(2013)
Available at
http://www.amazon.com/Fi
eld-Manual-Legal-Farmers-
Entrepreneurs/dp/1484965
191 & Kindle
57. Please Stay in Touch
New York Office:
535 Fifth Avenue, 4th Floor
New York, NY 10017
(212) 427-2049
cari@rinckerlaw.com
www.rinckerlaw.com
Illinois Office:
701 Devonshire Drive C12
Champaign, IL 61820
(217) 254-5458
@CariRincker @RinckerLaw
www.facebook.com/rinckerlaw
http://www.linkedin.com/in/caririncker
Snapchat + Periscope: CariRincker
Hinweis der Redaktion
Overtime, FDA did not feel like this created the necessary safeguards
Needed more control than OTC status
FDA started to become concerned about preventing the potential for the development of bacterial resistance to antimicrobial drugs administered through medicated feeds
ADAA – help facilitate the approval and marketing of new animal drugs and medicated feeds
FDA started getting some backlash stating that VFD was overly burdensome
In response, the FDA published several documents inviting public comment of VFD
Publication 1 – This was published around April 2012 and described the overall policy direction. It set forth FDA’s framework for instituting several key measures for ensuring the judicious use of medically important antimicrobial drugs in livestock. It included the possible elimination of feed and water use of medicated feeds and bringing all remaining. 2 key principles: Limit use of medically important antimicropial drugs in food-producing animals to those uses (1) considered necessary for assuring animal health and (2) that include veterinary oversight or consultation
Publication 2 – Published in December 2013; Outlined a detailed process and timeline for implementing the measures identified in GFI #209. This document discussed the transition of over-the-counter antimicrobial drugs to VFD marketing status. This document gives the timeline and defines what is medically important. In this publication, December 2013 was the target for drug sponosors to implement changes to use conditions of medically important antimicrobials in food and water to (1) voluntarily withdraw approved production uses such as “increased rate of weight gain” or feed efficiency and (2) after the label changes these production uses will no longer be legal; however, therapeutic uses are to be retained for treatment, control and prevention indications. Will require veterinary oversights. A key principle is to include a veterinarian in the decision-making process. It doesn’t require direct veterinarian involvement in the drug administration but it does require use to be authorized by a licensed veterinarian in the context of a VCPR. This means changing the marketing status from OTC to Rx or VFD. This includes water soluable products to Rx (“medicated drinking water”) and products used in or on feed to VFD (“medicated feed.”
Updated legislation aimed to make the process more efficient while continuing to provide public health protections
There is another Guidance for the Industry document #233 that is helpful – talks about the VFD itself and what should be prepoluated on the document
You can find the list online via FDA’s website
Avilamycin – used in swine to reduce diarrhea (E coli)
Florfenicol – used in fish to control mortality (various diseases according to fish type) and swine (control of SRD)
Tilmicosin – used in cattle for BRD and used in swine for SRD
The definition of Category II has been revised to eliminate the automatic classification of VFD drugs into Category II
FDA has published a list of states with VCPR- list will be updated periodically as FDA receives and verifies information from states if they change their VCPR definition or its applicability
Producers should already have a good relationship with their herd veterinarian, but an official VCPR will need to be in place because a VFD drug is only permitted under the professional supervision of a licensed veterinarian. Antibiotics that are deemed “medically important” to humans will now only be attainable to producers if they have a VFD from their herd veterinarian. “If you don’t routinely use a herd veterinarian, you will need one if you want to use medically important antibiotics moving forward,” says Chris Rademacher, an Iowa State University swine Extension veterinarian and GVL consultant.
(1) Extra-label drug use (“ELDU”) occurs when a drug in an animal is used in a manner that is not in accordance with the approved labeling. This can mean using a drug in a species for which it is not labeled, at a different dosage rate, frequency or route of administration, for diseases other than those on the label, or with a different withdrawal time than that listed.
(2) Only a veterinarian can make the necessary determination to use a drug in an extra-label manner. See American Veterinary Medical Association, “Animal Medicinal Drug Use Clarification Act (AMDUCA”) available at https://www.avma.org/KB/Resources/Reference/Pages/AMDUCA.aspx (last visited May 31, 2015). See also 21 CFR § 530 and 21 CFR § 530.41 (list of drugs that are prohibited for extra-label use in animals).
(3) For example, if a livestock animal is really sick, a veterinarian might allow for an antibiotic to be administered at a level that exceeds the dosage allowed on the label.
(4) This is done only in rare instances. Veterinarians are reluctant to ever treat an animal extra-label.
(5) If a livestock producer exceeds the dosage of the antibiotic without an extra-label prescription then he/she is in “violation” – if caught then this producer will be added to violators list. See American Veterinary Medical Association’s “Extralabeling Drug Use and AMDUCA: FAQ” available at https://www.avma.org/KB/Resources/FAQs/Pages/ELDU-and-AMDUCA-FAQs.aspx (last visited June 11, 2015).
Substitution information is OPTIONAL
If the VFD doesn’t specify that a generic version then the manufacturer may use either the approved pioneer or an approved generic VFD drug to manufacture the VFD feed
The Feed manufacture may not substitute a generic VFD drug for a pioneer VFD drug in a combination VFD feed if the generic VFD drug is not part of an approved combination VFD drug
If the expiration date isn’t noted then 6 mos is the default
Veterinarian can use judgment to determine whether a more limited period is warranted
If the VFD is silent on refills then the refill may not be authorized
Currently there are no approved VDF drugs that allow for refills or reorders as a condition of their approval, conditional approval or index listing
GFI #233 – Appendex A lists an example. Order should not induce confusion. There is now a recommended common format but it doesn’t have to be used.
If the duration isn’t listed on the VFD then default to the CVM Blue Bird Label Website on FDA’s website
Is the drug allowed to be used in combination with other drugs?
For example, Tilmicosin is currently approved to be used with Monesin for Cattle (to control BRD and coccidiosis) – choose 2 or 3 here
Veterinary cannot just provide any info they want with discretionary info. Limit to 558.6(b)(3) and (b)(4)
GFI 233 is titled Veterinary Feed Directive Common Format – Questions and Answers
There were a lot of requests for FDA to change the record keeping requirement to 1 year- kept it at 2 years
The expiration date should be on the label – if not then it cannot exceed 6 months from the date of issuance.
If the VFC will expire before the duration of use on the order then the client should contact his/her veterinarian to request a new VFD order
There are 2 kinds of distributors – those that ONLY distribute VFD feed and those that manufacture AND distribute VDF Feed
Must provide notification to the FDA prior to the time when they will be distributing the VFD drug