Description
This guidance is intended for sponsors of approved applications and abbreviated applications for new animal drugs containing medically important antimicrobials for use in non-food (companion), food-producing animals, or both, that are currently approved with over-the-counter marketing status. The guidance contains information for sponsors of such new animal drugs to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status.
Scope & Applicability
Product Classes
4Products subject to clinical investigation guidance.
Antimicrobial 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
Over-the-counter marketing status
Prescription marketing status
Stakeholders
4Assist sponsors in the nonclinical evaluation
Qualified personnel for recovery operations on live animals
Entity responsible for submitting applications under section 524B
team to contact regarding environmental statements
Regulatory Context
Attributes
2Review timeframe for pioneer labeling supplements
Review timeframe for generic labeling supplements
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 (5)
- 21CFR201.105§ 201.105 Veterinary drugs.
A drug subject to the requirements of section 503(f)(1) of the act shall be exempt from section 502(f)(1) of the act if it is a designated medical gas (as defined in § 201.161(c)(1) ) or a medically appropriate combination of designated medical gases and is in compliance with § 201.161 , or if all tRead 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 →
- 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 →
See Also (8)
- CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals (Status: Draft)
- Guidance for Industry: Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact Articles (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry (Status: Final)
- Over-the-Counter Monograph Order Requests: Format and Content (Status: Draft)
- Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Revised): Guidance for Industry (Status: Final)