Description
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 drugs (or VFD drugs).
Scope & Applicability
Product Classes
10a drug intended for use in or on animal feed which is limited by an approved application to use under the professional supervision of a licensed veterinarian; A drug intended for use in or on animal feed under professional supervision of a licensed veterinarian.; drugs approved for use under a veterinary feed directive; drug that requires a VFD for use in animal feed; Medicated feed containing a VFD drug.; Drug intended for use in or on animal feed; the client may also use the VFD drug alone
Complete medicated feed
Intermediate medicated feed
medicated feed containing a VFD drug; Animal feed containing a VFD drug
over-the-counter drugs used in combination with VFD drugs
Drugs intended for use in or on animal feed
VFD drug used in combination with other drugs; A combination new animal drug where at least one drug is a VFD drug.; A drug containing at least one VFD drug component; Multiple drugs used in VFD feed
classification of drugs relevance to VFD drugs; Drugs requiring no withdrawal period at lowest use level
classification of drugs relevance to VFD drugs; Drugs requiring withdrawal periods or regulated on no-residue basis; A list of Category II drugs is located in 21 CFR 558.4(d).; Drug category requiring a medicated feed mill license
used to manufacture medicated feed; A concentrated form of a drug used to manufacture medicated feed.; Concentrated drug form used to manufacture medicated feed; single ingredient component for medicated feed; Medicated feed mill license is required to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.; Concentrated drug form for manufacturing medicated feed; Concentrated form of animal drug used to manufacture medicated feed; Type A medicated articles fo
Stakeholders
8licensed professional who issues the VFD; Licensed professional who authorizes the use of VFD drugs.; Authorized professional who issues the VFD; party responsible for issuing and distributing the VFD; licensed professional authorized to issue a VFD; Professional who issues the VFD; Licensed professional who issues the VFD; The veterinarian should report to FDA any treatments that were not clinically effective
The receiving distributor who provides an acknowledgment letter.
An originating distributor distributing feed to another distributor.
Authorized representative conducting the inspection
Entity involved in investigational drug supply chain
person responsible for the animals; Owner, producer, or caretaker of the animals receiving VFD feed.; Owner or caretaker of the animals responsible for feeding; Person responsible for the animals receiving VFD feed; party that receives the VFD and the medicated feed for animals; The owner or person in charge of the animals; The original client should also make the new client (purchaser) aware of any VFD feed that already has been fed
Professional authorized to issue a VFD order; Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian.
Person performing research on drugs in medicated feed
Regulatory Context
Attributes
4Required label element for outsourcing facilities
Period required between last treatment and slaughter
length of time the VFD drug is allowed to be fed to the animals; The length of time the drug is to be fed to the animals; Length of time the animal feed is allowed to be fed; The length of time the VFD drug is to be fed to animals
Time required before slaughter to ensure no residues; time animals must be held after drug treatment before slaughter
Related CFR Sections (9)
- 21CFR558.6§ 558.6 Veterinary feed directive drugs.
(a) General requirements related to veterinary feed directive (VFD) drugs.Read full regulation →
- 21CFR226.110§ 226.110 Distribution records.
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 manRead full regulation →
- 21CFR510.7§ 510.7 Consignees of new animal drugs for use in the manufacture of animal feed.
(a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time of its removal from the establishment of a manufacturer, packer, or distributor of such drug, such manufacturer, packer, or distributor has an unrevoked written statement from theRead full regulation →
- 21CFR558.3§ 558.3 Definitions and general considerations applicable to this part.
(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is noRead full regulation →
- 21CFR530.11§ 530.11 Limitations.
In addition to uses which do not comply with the provision set forth in § 530.10 , the following specific extralabel uses are not permitted and result in the drug being deemed unsafe within the meaning of section 512 of the act:Read full regulation →
- 21CFR558.5§ 558.5 Requirements for liquid medicated feed.
(a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed:Read full regulation →
- 21CFR530.3§ 530.3 Definitions.
(a) Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, Read full regulation →
- 21CFR514.4§ 514.4 Substantial evidence.
(a) Definition of substantial evidence. Substantial evidence means evidence consisting of one or more adequate and well-controlled studies, such as a study in a target species, study in laboratory animals, field study, bioequivalence study, or an in vitro study, on the basis of which it could fairlyRead full regulation →
- 21CFR558.4§ 558.4 Requirement of a medicated feed mill license.
(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
J.D. Heiskell Holdings LLC
- 2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Lystn LLC dba Answers Pet Food
- 2025-04-22
CGMP/Non-Medicated Feed/Adulterated
Livestock Nutrition Center
- 2024-12-10
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Mid America Pet Food LLC
- 2024-04-30
CGMP/Medicated Feeds/Adulterated
Hi-Pro Feeds, LLC
- 2024-04-16
CGMP/Medicated Feeds/Adulterated
Appleton City Feed Service LLC
- 2024-03-19
CGMP/Medicated Feeds/Adulterated
Furst-McNess Company
- 2024-03-05
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Agila Corporation dba Woody’s Pet Food Deli
- 2024-02-13
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Battle Creek Co-op/CHS, LLC dba Progressive Nutrition
See Also (8)
- CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs (Status: Draft)
- CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (Status: Final)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- CVM GFI #220 Use of Nanomaterials in Food for Animals (Status: Final)
- CPG Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases (Status: Final)
- CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (Status: Final)