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
          Importation Program under Section 804 of the FD&C ActReports Importation Program under Section 804 of the FD&C Act
  
  	
    Share
    Post
    Linkedin

    Email
    PrintFDA has developed a pathway under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows importation of certain prescription drugs from Canada to:

significantly reduce the cost of these drugs to the American consumer,without imposing additional risk to public health and safety.FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal. States and Indian tribes may submit importation program proposals to FDA for review and authorization.

Section 804 Importation Program (SIP) Proposals

A SIP proposal needs to provide all the information required by the FD&C Act and FDA’s regulations. HHS provided information about demonstrating cost savings for the American consumer. A full list of requirements is provided in FDA’s regulations.

In particular, FDA regulations at 21 C.F.R. part 251 describe the requirements necessary for a sponsor of a SIP to demonstrate that their importation program will result in a significant reduction in the cost of eligible prescription drugs to the American consumer without posing any additional risk to the public’s health and safety. FDA has developed a resource, *Tips for SIPs*, which provides information to assist sponsors as they work to develop and implement a SIP proposal. A small entity compliance guide in question and answer format is also available to help in proposal development.

Visit responses to comments in the rulemaking for more information.

FDA Review Process

FDA’s evaluation of SIP proposals may include requests for additional information necessary to ensure the proposal meets the requirements in the statute and final rule. An example of FDA’s SIP proposal evaluation and potential implementation process is depicted below:

Section 804 Importation


Policies and Actions

FDA publishedImportation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide  to help small entities better understand the final rule (May 2022)
	FDA met with representatives from several states, the National Academy for State Health Policy and HHS to discuss the development of SIP proposals (March 2022). Visit HHS presentation for more information: Projecting Cost Savings for the American Consumer (PDF - 195 KB)
	FDA issued a final rule, Importation of Prescription Drugs, which describes the requirements for SIPs and provides FDA responses to comments about the proposed rule (October 2020)
	Executive Order 14036 on Promoting Competition in the American Economy (July 2021)FDA Authorization

FDA Authorizes Florida’s Drug Importation Program
	FDA authorization letter to Florida’s Agency for Health Care AdministrationContact Us

In accordance with Executive Order 14036, FDA engages directly with states or Indian tribes who want to propose a program or would like more information about SIP proposals.

If you represent a state or Indian tribe, ask questions or submit a SIP proposal by emailing the FDA at: SIPDrugImportsandRFP@fda.hhs.gov.

States and Indian tribes interested in working with the agency on a SIP proposal can also contact FDA’s Intergovernmental Affairs Staff at IGA@fda.hhs.gov to begin the conversation.

                                                                                  Content current as of:
      01/05/2024Reports

          
                        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