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 as well as for the new package type term single-patient-use container. These containers may be part of a drug, a biological product, or a combination product assigned to CDER, CBER, or certain combination products assigned to CDRH. Marketing applications for such products include: New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Premarket Approval Applications (PMAs), Premarket Notifications under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and requests for classification
submitted under section 513(f)(2) of the FD&C Act (De Novo request).


Posted on the FDA website on 2 October 2018