Secondary Packaging for Inhalation Drugs
Those who package inhalation drug products in semipermeable container closure systems, such as low density polyethylene (LDPE) containers, should have interest in a new FDA draft regarding secondary packaging for such products.
In the past, volatile chemicals have been found in some inhalation products with LDPE primary packaging, prompting recalls. In fact, FDA sampled a number of products in non-overwrapped LDPE vials and found the majority had chemical contaminants from packaging and labeling components.
Because of that, the draft guidance recommends inhalation products in LDPE primary packaging also have secondary packaging, with adequate control of each component and the manufacturing process. Information on the manufacture and controls of the secondary packaging should be included in a New Drug Application (NDA) or other submission to FDA to ensure reproducible lot-to-lot performance characteristics. This should include the qualitative and quantitative composition and physical characteristics of all packaging and labeling components. Information not in the pharmaceutical company's submission should be in the supplier's Type III Drug Master File (DMF).
The full text of the draft guidance can be viewed at http://www.fda.gov/cder/guidance/4168dft.pdf.