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  5. Importation Program under Section 804 of the FD&C Act
  6. Tips for Section 804 Importation Program Proposals (SIPs)
  1. Importation Program under Section 804 of the FD&C Act

Tips for Section 804 Importation Program Proposals (SIPs)

FDA’s tips for section 804 state importation program (SIP) proposals provide information to assist states and tribes develop their proposals. These tips are based on the agency’s review of SIPs and ongoing engagement with states and tribes.

General

  • Review the final rule’s comments: The final rule contains information that is essential for SIP sponsors 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. 
  • Review Part 251: FDA’s regulation at 21 CFR Part 251 describes the program requirements 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 the proposal. 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. 
  • Include eligible drugs: Not all drugs are eligible for importation under this program. Eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling. 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.
  • Explain how the proposal meets all requirements: The SIP proposal must explain how the SIP sponsor will ensure the U.S. drug supply chain is secure, imported drugs meet testing requirements, labeling, post-importation pharmacovigilance and other requirements will be met. 
  • Explain cost savings: The SIP proposal must explain how the SIP sponsor will ensure the SIP will result in a significant reduction in the cost to the American consumer of the eligible prescription drugs the SIP sponsor seeks to import. A variety of analytical approaches may be appropriate.

Labeling

  • Include a comparison of the labeling: Section 3(e)(8) requires 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, carton and container labeling and patient labeling (e.g., Medication Guide, Instructions for Use, patient package inserts) with all differences annotated and explained. The SIP proposal also must include a copy of the Health Canada’s Health Products and Food Branch (HPFB)-approved labeling. Provide this side-by-side comparison of the FDA-approved labeling and the proposed labeling for each drug identified in the SIP proposal.
  • Review drug labeling for sameness: Section 13(b)(4) requires 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.
  • Include the importer’s information: Under section 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

  • Ensure the drug is listed in the Orange Book: Section 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. The agency recommends, 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.
  • Ensure the relabelers and foreign sellers are registered with FDA: 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 the proposed foreign seller is registered with a business operation ‘SIP foreign seller.’ Contact edrls@fda.hhs.gov for questions and assistance with registration.
  • Use the only authorized port: 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 251.17(b)].
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