Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CVM Updates

CVM Updates Home
          Animal & Veterinary
          News & Events
          CVM Updates
          FDA Releases Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food AnimalsCVM Updates FDA Releases Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Update: November 22, 2023**

In response to requests filed by stakeholders, the FDA is extending the comment period for Draft GFI #273, “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals,” for an additional 10 days. The comment period will now close on January 5, 2024. For additional information, see: Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability; Extension of Comment Period.


September 25, 2023

Today, the U.S. Food and Drug Administration released a draft guidance for industry (GFI) to provide recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved medically important antimicrobial animal drugs with indications that currently lack a defined duration of use.

When a drug lacks a defined duration of use, it means the labeling does not include information about how long a product can be administered for an approved indication.

As of September 25, 2023, there are nearly 100 approved animal drug applications for medically important antimicrobials that have one or more indications without a defined duration of use.

The recommendations in the draft guidance only affect medically important antimicrobials approved for use in or on the feed of food-producing animals.  All approved uses of medically important antimicrobial drugs in other dosage forms (e.g., injectable, intermammary, tablet, etc.) already have appropriately defined durations of use.

Revising product use conditions of affected products to better target when and for how long a drug may be used to effectively treat, control, or prevent the disease(s) for which the product is indicated provides for the continued effective use of these products while minimizing the extent of antimicrobial drug exposure. These changes support FDA’s judicious use efforts and are intended to help mitigate the development of antimicrobial resistance.

In January 2021, FDA published and sought public comment on a concept paper titled “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.” FDA considered all information and public feedback received in response to the concept paper during development of this draft guidance.

FDA is accepting public comments on “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals,” through December 26, 2023. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2023-D-2925 into the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2023-D-2925 on each page of your written comments.

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:

Draft Guidance for Industry #273: Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals
	Federal Register Notice: Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability
	List of Approved Medically Important Antimicrobial Administered in or on the Feed of Food-Producing Animals that Lack a Defined Duration of Use
	Concept Paper: Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed**Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.**

                                                                                  Content current as of:
      11/22/2023CVM Updates
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop