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Guidance on Package Types for Injectable Products


Federal Register Notice: FDA is making available a draft guidance for industry entitled Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,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. It has been developed to provide industry with 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. It also 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. To download this guidance, click here. To view this notice, click here.