The FDA has drafted new guidelines for drug makers on improving the safety of inhalation drug products packaged in semipermeable container closure systems. The draft guidance was issued to address public health concerns ?raised by the possible leaching and entry of chemical contaminants into inhalation drug products packed in semipermeable primary container closure systems,? according to the document.
Although the effects of contamination of inhalation drug products by this type of packaging are unknown, it is possible that the contaminants can induce bron-chospasms, especially because patients using these inhalers are sensitive to respiratory irritants and sensitizers.
The guidance provides recommendations on appropriate protective secondary packaging, imprinting of the primary container instead of using paper labels, and the number of unit-dose containers that should be put within each secondary package.