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:

                Reports

Reports

                        Reports on Agency Policies and Initiatives


                        Budgets
          Combination Products Performance Reports
          Economic Impact Analyses of FDA Regulations
          User Fee Reports Home
          About FDA
          Reports, Manuals, & Forms
          Reports
          Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical InputsReports Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs
  
  	
    Share
    Post
    Linkedin

    Email
    Print**On this page:** Introduction | About the list | Public comment | Contact FDA | Related links


Introduction

On August 6, 2020, the President issued an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (archived page). This executive order directed the U.S. Food and Drug Administration (FDA) to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.

The goal of this work is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological, and nuclear threats. To accomplish this goal, the executive order seeks to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on foreign manufacturers of these products.

The executive order also directs the FDA to coordinate with our federal partners on a number of additional issues, including strategies for acquiring the products on the list, accelerating domestic manufacturing, and identifying and addressing supply chain vulnerabilities. The FDA is working on this coordination. The FDA believes that the adoption of innovative technologies, such as advanced manufacturing techniques, could enable U.S.-based pharmaceutical manufacturing to bolster its competitiveness with foreign countries and help ensure a stable supply of drugs critical to the health of U.S. patients. As companies look to increase domestic manufacturing of the products on this list, they are encouraged to consider adopting advanced manufacturing technologies.

The FDA will continue to collaborate with the Department of Health and Human Services (HHS) and other federal partners on this issue as directed by the executive order.

About the list

**Download the list** (PDF, 768KB)

The list includes:

Drug and Biologic Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(c) of the Executive Order 13944
	Device Medical Countermeasures and Critical Inputs for the List Described in Section 3(c) of the Executive Order 13944The FDA has worked, in consultation with other federal partners, to develop a list of drug and biological product essential medicines and medical countermeasures. Additionally, device medical countermeasures are included on the list.

Generally, the essential medicines we identified are those that are most needed for patients in U.S. acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions. The medical countermeasures we identified are FDA-regulated products (biologics, drugs, devices) that meet the definition of a "medical countermeasure" provided in the executive order and that we anticipate will be needed to respond to future pandemics, epidemics, and chemical, biological, and radiological/nuclear threats.  When identifying essential medicines and medical countermeasures, we focused on including those that are medically necessary to have available in adequate supply which can be used for the widest populations to have the greatest potential impact on public health.

The critical inputs we identified include active pharmaceutical ingredients of essential medicines and medical countermeasures, as well as ingredients or components that possess unique attributes essential in assessing the safety and effectiveness of such products.

The device medical countermeasure list includes diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, active vital sign monitoring devices, devices for vaccine delivery, and devices for management of acute illnesses such as ventilators, among others.

The criteria FDA used to identify essential medicines, medical countermeasures, and critical inputs are available here: **Criteria For Identifying Human Drug and Biologic Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(c) of the Executive Order (EO) 13944**(PDF, 126KB)

Public comment

FDA has opened a public docket for stakeholders to offer specific comments on the following questions.

Do you have any feedback on the criteria developed by the FDA for inclusion of essential medicines, medical countermeasures, or their critical inputs on the list required by Executive Order 13944?
	Are there any additional essential medicines, medical countermeasures, or critical inputs you believe should be included on the list or ones you think should be removed and why?
	Do you have any feedback on how frequently, and by what type of process, the list should be evaluated to determine the need for any additions or removals?**Please submit all comments to the public docket** (FDA-2020-N-2123, available at Regulations.gov).

Contact FDA

For media inquiries about this list, contact: FDAOMA@fda.hhs.gov

For all other questions about this list, contact: EssentialMedicinesEO@fda.hhs.gov

Related links

May 23, 2022: Essential Medicines Report Now Available - The nation’s first Essential Medicines Supply Chain and Manufacturing Resilience Assessment by the U.S. government was released by the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR). The assessment addresses pharmaceutical supply chain constraints identified in the Biden-Harris Administration’s 100-day supply chain review report, specifically those constraints affecting critical medicines on the FDA’s essential medicines list. Download the full report here.
	August 6, 2020: Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (White House, archived page)
	October 30, 2020: FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
	Advanced Manufacturing – Learn more about FDA’s advanced manufacturing activities to support public health emergency preparedness and response
	Counterterrorism and Emerging Threats

                                                                                  Content current as of:
      05/23/2022
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical DevicesTopic(s)
			  Drug Shortage
				    				       				    				       Terrorism
				       				    				       OutbreakReports

          
                        Reports on Agency Policies and Initiatives


                        Budgets
          Combination Products Performance Reports
          Economic Impact Analyses of FDA Regulations
          User Fee Reports
 
 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