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Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use - Draft Guidance for Industry

A draft guidance has been posted titled, "Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in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."

This guidance provides industry with the Food and Drug Administration’s (FDA’s) recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers. Specifically, this guidance 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. Marketing applications for such products include: New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Premarket Approval Applications (PMAs), and Premarket Notifications under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM468228.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery