What’s New/Significant

The Food and Drug Administration (FDA) issued a final rule on Sept. 24, 2020, to allow importation of certain prescription drugs from Canada without the manufacturer’s authorization. Under this final rule, states and Indian tribes and, in some instances, pharmacists and wholesalers, may submit importation program proposals to the FDA for review and authorization. The sponsors of the resulting importation programs must demonstrate that their importation program poses no additional risk to the public’s health and safety and must result in a significant reduction in the cost of covered products to the American consumer.

Rationale

The purpose of the final rule is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to public health and safety. The final rule implements the commercial importation provisions in subsections (b) to (h) of Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA), which authorizes Section 804 Importation Programs (SIPs) as the means of importation.

SIP Proposal. SIP sponsors must specify the eligible prescription drug to be included in the SIP. Eligible drugs are those that could be sold legally in the Canadian or U.S. market with appropriate labeling. Not included as eligible prescription products are controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, intrathecally or intraocularly injected drugs, or drugs subject to a risk evaluation and mitigation strategy (REMS).

The SIP must identify, among other things:

  • The foreign seller, which must be licensed in Canada and registered with the FDA, that will purchase the eligible prescription drug directly from the manufacturer.
  • The importer, which must be either a distributor or a pharmacist licensed in the U.S., that will buy the drug directly from the foreign seller.
  • 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.
  • How the labeling requirements of the FDCA will be met, and a description of the storage, handling and distribution practices of supply chain participants, including transportation providers.
  • How the integrity of the supply chain will be secured.

The SIP sponsor, the foreign seller and the importer must maintain appropriate documentation relating to their respective responsibilities.

Pre-Import Request. After FDA authorization, the importer must submit a pre-import request at least 30 days prior to the date a SIP drug shipment arrives at a specific port of entry authorized by the FDA, where it will be inspected. The request must identify the SIP sponsor, the manufacturer, the importer and the foreign seller, as well as information about the product.

Either the manufacturer or the importer must conduct testing of the SIP drug for authenticity and degradation, and to ensure compliance with specifications and standards (statutory testing). If statutory testing has not been performed prior to arrival in the U.S., the importer must arrange for the statutory testing to be performed by a qualifying laboratory in the U.S. and ensure that the drug complies with FDCA labeling requirements.

Post-Importation Requirements. SIP sponsors must provide the FDA with information relating to:

  • The SIP’s cost savings to the consumer.
  • Adverse events, field alerts and other reports.
  • Recalls and related actions.

Authorization for SIPs terminate automatically after two years unless an extension is granted or the authorization specifies a shorter period of time. The FDA can also terminate an SIP “at any time” for failure to meet certain requirements under the final rule or “under any other circumstances in FDA’s discretion.”

Effective Date

The Final Rule becomes effective 60 days after the date of publication in the Federal Register.