Today’s prepublication of the Federal Register contains the proposed rule for drug importation from Canada.  The proposed rule is 172 pages long and outlines the FDA expectations for the safe importation of drug products from Canada.  Section 804 Importation Programs (SIPs) provides the basis for each request for importation and provides the importation requirements.  The supply chain for each drug under a SIP would be limited to three entities, i.e., one manufacturer, one foreign seller, and one importer.

Product to be included in the program must be approved by Health Canada and have appropriate identification and serialized numbers.  The proposal notes that “FDA proposes that the foreign seller be a party that is licensed by Health Canada as a wholesaler and registered with FDA as a foreign seller, and that the importer be a wholesaler or pharmacist licensed to operate in the United States.”

There are numerous testing and relabeling requirements in the proposed rule to assure the quality and safety of the products imported.  Importers would be required to report savings to the consumer, among other data, to the FDA as part of post importation requirements.

Of course, with 172 pages of text, it will be important to read the entire document and the brief summary provided above only scratches the surface of the requirements and obligations under this program.  To review the full proposed rule, please click here.