Description
In September 2018, FDA unveiled a 5-year action plan for supporting antimicrobial stewardship in veterinary settings. This plan builds upon the important steps the Center for Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in animals, and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control, or prevention of specific diseases. This plan includes an action item intended “to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use.”
Scope & Applicability
Product Classes
9Antimicrobial drugs important to human medicine used in food-producing animals; Drugs administered in the feed of food-producing animals with undefined durations of use.; Establishing appropriately defined durations of use for all medically important antimicrobials.; Antimicrobial drugs important to human medicine administered in feed
Approved use of two or more active ingredients in animal feed
Complete medicated feed containing a combination of new animal drugs
Final medicated feed intended for consumption; Medicated feed intended for consumption as a complete feed; medicated feed intended for direct consumption by animals; Medicated feed intended for direct consumption by animals
intermediate medicated feed; A medicated feed intended for further manufacture of another medicated feed.; Intermediate medicated feed; Intermediate medicated feed product; medicated feed intended for further mixing; Intermediate medicated feed used to manufacture Type C feed
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
Medically important antimicrobial drugs fed to food-producing animals
Affected products are now VFD products requiring the oversight of a licensed veterinarian.
Specific category of animal drug products
Stakeholders
6Entity responsible for submitting applications under section 524B
The VMF holder should submit the appropriate labeling components.
The original applicant of an approved NADA
Professional providing oversight for antimicrobial drug use; Veterinarian is to determine the actual duration that the drug will be used; Professional ordering the duration of use for antimicrobial drugs
FDA provides recommendations to animal drug sponsors on revising product use conditions.
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.
Regulatory Context
Attributes
7The length of time a drug is administered to animals; The defined timeframe for drug administration being established in labeling.
Labeling lacking information regarding duration of feeding
Labeling information ensuring drug use only when needed
Qualify the sponsor for 3-year exclusivity under section 512(c)(2)(F)(iii) of the FD&C Act.
Must not exceed 6 months after the date of issuance
The duration that cannot be exceeded for a single course of therapy.; Directions section should state the maximum duration of use permitted for a single course
The duration to be ordered by the veterinarian in accordance with labeled directions.
Identified Hazards
Hazards
1Public health threat resulting from loss of effectiveness of antimicrobial therapies; Efforts to mitigate the development of antimicrobial resistance.; Public health concern that labeling changes aim to mitigate.; development and spread of antimicrobial resistance encouraged by certain practices
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 →
- 21CFR25.33§ 25.33 Animal drugs.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR514.115§ 514.115 Withdrawal of approval of applications.
(a) The Secretary may suspend approval of an application approved pursuant to section 512(c) of the act and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing on a finding that there is an imminent hazard to the health of man or of the anRead full regulation →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead 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 →
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead 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 →
- 21CFR558.3§ 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 →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
See Also (8)
- CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers (Status: Final)
- CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (Status: Final)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)
- CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information (Status: Final)
- Applications for Premarket Review of New Tobacco Products: Draft Guidance for Industry (Status: Draft)
- Modified Risk Tobacco Product Applications: Draft Guidance for Industry (Status: Draft)