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.

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