HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets

HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets

December 19, 2019, Covington Alert

On December 18, 2019, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a notice of proposed rulemaking on “Importation of Prescription Drugs” (the “NPRM”) and a Draft Guidance titled “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act” (the “Draft Guidance”).