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MEMORANDUM

Plasma Derived from Therapeutic Plasma Exchange December 1984

Download the Final Memorandum
Final
Docket Number:
FDA-2013-S-0613
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

In an April 1, 1983, Notice published in the Federal Register (Vol. 48, No. 64, page 14048), the Food and Drug Administration (FDA) advised that plasma derived from therapeutic exchange procedures is a biological product subject to the licensing provisions of the Public Health Service Act [42 USC 262 (a)] then collected and shipped for further manufacture into in vitro diagnostic products.

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