www.fdanews.com/articles/188743-fda-guidance-revises-packaging-terms-for-injectable-medical-products
FDA Guidance Revises Packaging Terms for Injectable Medical Products
October 10, 2018
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.”
The 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.
The agency revised the terms after the improper use of single-dose containers led to the transmission of bacterial and viral infections in multiple patients.