The FDA’s proposed rule would, for the first time, implement Section 804 of the Federal Food, Drug and Cosmetics Act (FDCA), which allows certain small-molecule drugs approved in Canada to enter the U.S. market – if the Health and Human Services secretary certifies that the drugs would pose no additional risk to public health and safety and that they would result in a significant reduction in cost.

Here’s how the FDA proposes to implement that 20-year-old provision:

States or certain other nonfederal governmental entities would submit proposals for a Section 804 importation program (SIP) to the FDA for review and authorization. SIPs could be co-sponsored by a pharmacist, wholesaler, or another state or governmental entity.

After the FDA authorizes a SIP, the importer would submit a pre-import request to the agency at least 30 days before the scheduled arrival date or entry of a shipment to an authorized port of entry.

The importer would electronically file an entry for consumption in the Automated Commercial Environment (ACE) or other authorized electronic data interchange system for each drug imported.

The importer would arrange for statutorily prescribed testing of the drug in the U.S.

Results of the testing would be reviewed and accepted by the FDA.

The drug would have to be relabeled to comply with all labeling requirements under the FDCA before it can be distributed in the U.S. This would include track-and-trace requirements.

Following importation, the SIP sponsor would be required to provide the FDA with data and information about the SIP, including cost savings from the program.

Importers would be responsible for submitting adverse event, medication error, field alert and other reports to a drug’s manufacturer and to the FDA.

The SIP sponsor would initiate necessary recalls.

Under the proposed rule, each SIP must include:

  • an explanation of how the program is expected to produce a significant reduction in the cost of the covered drugs;
  • a list of the covered drugs, which must be approved by Health Canada and, aside from their Canadian labeling, meet the conditions in an FDA-approved new drug application or abbreviated new drug application;
  • the identity of the foreign seller in Canada that will purchase the drug directly from its manufacturer (the seller should be licensed by Health Canada as a wholesaler and registered with the FDA as a foreign seller);
  • the identity of the importer in the U.S. that will buy the drug directly from the foreign seller (the importer would be a wholesaler or pharmacist licensed to operate in the U.S.);
  • a written recall plan that describes the procedures to perform a recall of an imported drug and specifies who will be responsible for conducting those procedures.

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