Draft Guidance for Industry on Inhalation Drug Products Packaged in Semipermeable Container Closure Systems; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Inhalation Drug Products Packaged in Semipermeable Container Closure Systems." This draft guidance is intended to provide guidance for industry on inhalation drug products that are packaged in semipermeable primary container closure systems. This draft guidance also covers related chemistry, manufacturing, and controls (CMC) considerations. FDA is issuing this draft guidance to address public health concerns raised by the possible leaching and entry of chemical contaminants into inhalation drug products packaged in semipermeable primary container closure systems.