Trump Administration Issues Proposed Rule on Importation of Prescription Drugs
On Dec. 18, 2019, President Trump, along with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), issued a notice of proposed rulemaking (NPRM)
that, if finalized, would allow states to import certain prescription drugs from Canada. In addition, the administration announced a new draft guidance for industry
that allows drug manufacturers to important their own prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)
Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.
Read the HHS press release.
Read Importation of Prescription Drugs Proposed Rule.
Read new draft guidance for industry.