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:

                President's Emergency Plan for AIDS Relief (PEPFAR)

President's Emergency Plan for AIDS Relief (PEPFAR)

                        PEPFAR Database Frequently Asked Questions
          Quick Reference Guide for PEPFAR Database Home
          International Programs
          President's Emergency Plan for AIDS Relief (PEPFAR)
          PEPFAR Database Frequently Asked QuestionsPresident's Emergency Plan for AIDS Relief (PEPFAR) PEPFAR Database Frequently Asked Questions
  
  	
    Share
    Post
    Linkedin

    Email
    Print**PEPFAR Database**

1. What are the main uses of the PEPFAR database?
	The President’s Emergency Plan for AIDS Relief (PEPFAR) database is used by stakeholders to see which antiretroviral (ARV) drugs have been tentatively approved or approved by FDA and are therefore eligible for procurement under the PEPFAR program. The PEPFAR database is also used to generate reports and access FDA-reviewed product labeling, proper storage conditions, current manufacturing information, and more.

2. What products are in the PEPFAR database?
	The PEPFAR database includes all ARV drugs tentatively approved and approved that are reviewed by FDA in association with PEPFAR. The database also includes ARV drugs not reviewed in association with PEPFAR but eligible for listing in the database after meeting certain stability conditions; these products are noted with a * in the FDA Original Action Sequence for PEPFAR number field.

3. What products are not in the PEPFAR database?
	FDA ARV drugs NOT reviewed in association with PEPFAR and NOT eligible for listing are not included in the PEPFAR database. Limited information about all FDA-approved ARV drugs may be found in Drugs@FDA.

4. How was information about these products previously available?
	Prior to January 29 , 2020, a static table of *Tentatively Approved and Approved Antiretrovirals Eligible for Procurement Under the President's Emergency Plan for AIDS Relief* was available with the authorization of each company that sponsored the application. All information from the former web table is included in the PEPFAR database.

5. What is FDA’s role in PEPFAR?
	FDA plays an integral role in PEPFAR by ensuring safe and effective ARV drugs are available for procurement through PEPFAR so these drugs can get to countries with high rates of HIV infection in a timely manner. Since 2004, FDA has encouraged sponsors worldwide to submit U.S. marketing applications for single entity, fixed-combination, and co-packaged versions of previously approved ARV drugs. To speed up approval, FDA uses its existing processes including expedited review for PEPFAR ARV drugs, while ensuring that these products meet the same standards as similar products for the U.S. market and our own citizens.
FDA's specific activities in support of PEPFAR are as follows:

FDA reviews original marketing applications using its normal standards for approval. Drugs that would otherwise receive “final” approval, but because of the existence of a patent and/or exclusivity, receive “tentative” approval. Drugs that are tentatively approved are not eligible for marketing in the U.S. but can be distributed outside the U.S., and money from the PEPFAR program can be used to procure them, usually at a cost savings to the program.
	FDA reviews amendments to tentatively approved and approved applications that allow for manufacturing changes and other modifications that can lead to reduced cost of ARV drugs.
	Very importantly, FDA engages with ARV companies to assist them in the submission of drug applications for ARV drugs and fixed-combinations needed to meet the demands of worldwide treatment of HIV.
	FDA collaborates with global health entities such as the World Health Organization (WHO), which recognizes FDA-approved or tentatively approved ARV drugs on its lists of quality-assured drugs.

6. What PEPFAR products can companies submit for FDA review?
	In addition to the tentatively approved and approved ARV drugs that are eligible for procurement under PEPFAR, there is a separate list of ARV drugs and ARV fixed-combinations that are most needed to meet the needs of HIV treatment in the developing world and PEPFAR countries. Companies should refer to this list when considering submission of applications for ARV drugs intended for PEPFAR use.

7. What information is available for a PEPFAR application that is withdrawn?
	When an application is withdrawn by the company that sponsored the application, all non-public information authorized for posting by the sponsor is removed. The application number, application type, established name, active ingredient, strength, dosage form, formulation, company, current approval status, application status history, and company contact information remain available. All other information about the application is removed from the PEPFAR database.

8. What is the FDA Original Action Sequence for PEPFAR number?
	The FDA Original Action Sequence for PEPFAR is assigned based on the original action date. Therefore, FDA Sequence number 1 is assigned to the application with the oldest original action. Subsequent actions such as other types of approvals or withdrawal of the application do not change the FDA Sequence number.

9. What is the meaning of the information in the field Currently Manufactured?
	Information provided in the field “Currently Manufactured?” is further explained as:

Yes = Company that sponsored the application is currently manufacturing the finished drug product
	No = Company that sponsored the application is NOT currently manufacturing the finished drug productApplications that are withdrawn by the company are also listed as No (see Approval Status to filter for withdrawn applications). These fields will appear blank for companies who have not submitted information about the current manufacturing status of their finished drug products.

10. Where does the information come from that is listed in Currently Manufactured?
	Current manufacturing information comes directly from the company that sponsored the application and is updated at least annually. For more up-to-date information on the current manufacturing status of an individual product, please contact the company directly. See Company Contact Information.

11. How can I search the PEPFAR database?
	Please visit the PEPFAR database Quick Reference Guide.

12. How often is the PEPFAR database updated?
	The PEPFAR database is updated daily.

13. Where does the information in the PEPFAR database come from?
	Most of the information in the PEPFAR database comes from internal systems used by FDA staff to track information about approved and tentatively approved applications except for information provided in the field “Currently Manufactured”. See FAQ #10 for more information.

14. How do sponsors provide authorization to FDA to provide this information?
	Sponsors provide authorization to FDA to post certain non-public information on this public website by signing a sponsor authorization form. A letter requesting this authorization was sent from FDA to each company sponsoring an application reviewed under PEPFAR with a current approval status of approved or tentatively approved. Each company appearing in this database with fully populated information fields has provided authorization. The letter was not sent to companies sponsoring only withdrawn applications (see FAQ #7 for more information about withdrawn applications).

15. How can I get further assistance?
	For further assistance, contact FDA’s Division of Drug Information.

Phone

Toll Free (855) 543-3784 or (301) 796-3400

Email

druginfo@fda.hhs.gov

Mail

Division of Drug Information
10001 New Hampshire Ave
Hillandale Building, Suite 4100
Silver Spring, MD 20993

                                                                                  Content current as of:
      01/29/2020
              
              
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  Prescription DrugsHealth Topic(s)
			  HIV/AIDSLaw(s) & Regulation(s)
			  President's Emergency Plan for AIDS Relief (PEPFAR)President's Emergency Plan for AIDS Relief (PEPFAR)

          
                        PEPFAR Database Frequently Asked Questions
          Quick Reference Guide for PEPFAR Database
 
 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