Health Resources and Services Administration July 23, 2014 – Federal Register Recent Federal Regulation Documents

HHS is announcing the availability of an interpretive rule providing HHS's interpretation of section 340B(e) of the Public Health Service Act (PHSA), entitled ``Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).