FDA final rule and guidance on importation of prescription drugs

FDA finalized a rule and guidance allowing states to submit prescription drug importation proposals and manufacturers to re-label drugs for importation

Larry Kocot

Larry Kocot

Principal, Advisory, KPMG LLP

+1 202-533-3674

On September 24, the FDA issued a Final Rule that “allows states (including the District of Columbia and territories), Indian tribes and — in certain future circumstances — pharmacists and wholesalers, to submit importation program proposals to the FDA for review and authorization.” The final rule does not enable importation for personal use. The FDA also issued a final industry guidance document instructing manufacturers on how to re-label prescription drugs for importation into the United States.

These documents largely finalize polices detailed in the Notice of Proposed Rulemaking (NPRM). There are some modifications to the NPRM that were made in the final rule; however, the final rule does not address the most significant objections of stakeholders, such as on the ability to reliably track and distinguish Canadian from American product for the integrity and security of the US automated supply chain. Initial reporting on stakeholder reaction so far reiterates the initial concerns with the proposal, and indicates that drug manufacturers, US pharmacists, as well as Canada may address their objections in court.


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