US: FDA draft guidance packaging and labeling of injectables

The US FDA published a draft guidance for industry on the “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”.
When finalized, this guidance provides industry with the FDA’s recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use. Specifically, it provides FDA’s revised definitions for single-dose and multiple-dose containers, and introduces the definition of a new package type term, “single-patient-use” container (FDA, 21 October 2015).
Click here to download the draft guidance document (116 kB).
Click here for more information about the NVC E-Course Pharmaceutical Packaging.

If you have any questions about this subject, please contact us: info@nvc.nl, +31-(0)182-512411. This item is also included in our monthly overview, the NVC Members-only Update.