FDA issues final rule, guidance on importing prescription drugs

The Food and Drug Administration yesterday released a final rule allowing states, territories and Indian tribes 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, and may be able to establish them in the future, FDA said.

The agency also issued final guidance describing procedures for drug makers importing foreign-made prescription drug and biological products approved by the FDA. In addition, the Centers for Medicare & Medicaid Services issued guidance on the rule’s implications for the Medicaid Drug Rebate Program.

President Trump in July issued an executive order directing the agency to take actions to allow for the importation and re-importation by states, wholesalers and pharmacies of Food and Drug Administration-approved drugs from Canada.