FDA issues proposed rule, guidance on importing prescription drugs

The Food and Drug Administration today released a proposed rule that would allow states and other non-federal government entities to establish programs to import certain FDA-approved prescription drug and biological products from Canada. Pharmacists and wholesalers could co-sponsor the programs, which would have to demonstrate that the imported products pose no additional risk to public health and safety and would cost consumers significantly less. The agency also issued draft guidance describing procedures for drug makers importing foreign-made prescription drug and biological products approved by the FDA. FDA will accept comments on the proposed rule for 75 days and on the draft guidance for 60 days after their publication in the Dec. 23 Federal Register.