US proposes rule to let states import some Canadian prescription drugs

December 19, 2019

The U.S. Food and Drug Administration has proposed a rule that, if implemented, would allow states to import certain prescription drugs from Canada.

“The purpose of the proposed rule is to lower prices and reduce out of pocket costs for American patients,” the FDA said in a Federal Register notice expected to be published on Dec. 23.

Under the rule, the program would be implemented through the Federal Food, Drug, and Cosmetic (FD&C) Act’s Section 804 Importation Programs (SIPs) and managed by states or certain non-federal entities. A pharmacist or wholesaler could co-sponsor a SIP.

Each eligible prescription drug import must be approved for use in both Canada and the U.S. and include appropriate labeling.

“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,” FDA said...

This was excerpted from the 19 December 2019 edition of American Shipper.

Topic(s)

Exports

International Trade and Border Management

Information source

Industry Publication

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The foregoing information is provided for informational purposes only and is not intended as, nor should it be considered, professional advice or a substitute for conducting your own thorough research and review. Before making any decisions or taking any action based on the information provided, you should conduct your own independent investigation and/or seek professional advice from a qualified expert in the relevant field. The CSCB disclaims all liability for actions taken or not taken based on the information provided.

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