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
          Tips for SIPsReports Tips for SIPs
  
  	
    Share
    Post
    Linkedin

    Email
    PrintFDA is providing high-level tips to assist sponsors in development of their section 804 Importation Program Proposals. These are tips FDA has identified based on our review of SIP proposals and ongoing engagement with stakeholders. FDA will update this page as new information arises.

**General**

**The final rule contains information that is essential for SIP Sponsors in order to develop a SIP proposal that FDA can authorize**. SIP sponsors may find the comment and response section of the preamble to the final rule to be particularly useful.
	**FDA’s regulation at 21 CFR Part 251 describes the requirements of the SIP program and articulates the procedures that SIP Sponsors must follow**. All items in §251.3 must be included and adequately explained in the SIP proposal for FDA to authorize a SIP proposal.  In addition, refer to §§ 251.9 to 251.17 for additional requirements and considerations. The SIP proposal should be as specific as possible with supporting documentation for processes and plans.
	**Not all drugs are eligible for importation under the SIP program**. Eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling. Furthermore, certain types of drug product are excluded by the final rule. If it is not possible to relabel a product without affecting the container closure system, such as a blister pack, then the product cannot be imported under a SIP. The final rule does not allow repackaging of drugs that breach the container closure system, such as a blister pack, which could introduce unnecessary risk of adulteration, degradation, and fraud for drugs imported under a SIP. Visit Q2 of the Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide for more information.
	The SIP proposal must explain how the SIP sponsor will ensure that the supply chain is secure, imported drugs meet testing requirements, and labeling, post-importation pharmacovigilance, and other requirements will be met.
	**The SIP proposal must also explain how the SIP sponsor will ensure that the SIP will result in a significant reduction in the cost to the American consumer of the eligible prescription drugs that the SIP sponsor seeks to import**. The HHS presentation Projecting Cost Savings for the American Consumer outlines methods and considerations for providing that explanation in the SIP proposal.**Labeling**

**Section 251.3(e)(8) requires that the SIP proposal include a copy of the FDA-approved drug labeling for the FDA-approved counterpart of the eligible prescription drug, a copy of the proposed labeling that will be used for the eligible prescription drug and a side-by-side comparison of the FDA-approved labeling and the proposed labeling**. This must include the Prescribing Information (PI), carton and container labeling, and patient labeling (e.g., Medication Guide (MG), Instructions for Use (IFU), patient package inserts (PPI)), with all differences annotated and explained. The SIP Proposal must also include a copy of the Health Canada’s Health Products and Food Branch (HPFB)-approved labeling. Ensure that this side-by-side comparison of the FDA-approved labeling and the proposed labeling is provided for each drug identified in the SIP Proposal.
	**Section 251.13(b)(4) requires that the labeling of the drug is the same as the FDA-approved labeling under the applicable new drug application (NDA) or abbreviated new drug application (ANDA) at the time the drug is sold or dispensed, with certain exceptions**. An eligible prescription drug’s labeling can only deviate from the FDA-approved labeling in the ways listed at 251.13(b)(4)(i)-(vii). Ensure the content and format of the container and carton labeling of each eligible prescription drug included in the SIP proposal is the same as the FDA-approved carton and container labeling.
	**Under section 251.13(b)(4)(iii), the name and place of business of the importer must be included in all imported drug labeling**. Human prescription drug labeling includes the package insert, patient labeling (medication guides, patient package inserts, and/or instructions for use) and/or carton and container labeling.**Importation and Registration**

Section 251.3(e)(6) requires adequate evidence that each Health Products and Food Branch Canada-approved drug’s FDA-approved counterpart drug is currently commercially marketed in the U.S. We recommend, at a minimum, including information showing that each drug product is listed in the Active Section of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
	Relabelers identified in a SIP Proposal should be registered with FDA with a business operation ‘relabel’.  Similarly, any **Foreign Seller(s) designated in a SIP proposal must be registered with FDA** before FDA will authorize the SIP proposal. Ensure that the proposed foreign seller is registered with a business operation ‘SIP Foreign Seller.’ Contact edrls@fda.hhs.gov for questions and assistance with registration.
	**Entry and arrival of a shipment containing an eligible prescription drug is limited to the U.S. Customs and Border Protection (CBP) port of entry authorized by FDA**. At this time, the only port of entry that has been authorized by FDA is located in Detroit, Michigan [21 CFR [21 CFR 251.17(b)].

                                                                                  Content current as of:
      09/20/2023Reports

          
                        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