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Tips for SIPs

FDA 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

  1. 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.
  2. 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.
  3. 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.
  4. 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. 
  5. 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

  1. 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.  
  2. 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.
  3. 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

  1. 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.
  2. 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.
  3. 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)].
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