FDA guidance on inhaler packaging

FDA has issued draft guidance on “inhalation drug products packaged in semipermeable container closure systems.” These products are commonly used in the treatment of asthma or chronic obstructive pulmonary disease.

Over time, chemical impurities can accumulate in the drug from degradation of formulation components, leaching from the container closure system, or entry from the local environment, which can include secondary packaging. The consequences to patients are uncertain but could include bronchospasm.

The draft guidance includes recommendations on appropriate protective secondary packaging; embossing and debossing of the primary container in lieu of paper labels; and the number of unit-dose containers to be contained within each protective secondary package. The guidance applies to drugs already on the market in the United States and to those under development.

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