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FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002


Division of Federal-State Relations (HFC-150), U.S. Food and Drug Administration, 5600 Fishers Lane, Room 12-07, Rockville, Maryland 20857

Document Type:
Guidance Manual
This Compliance Program covers Source Plasma, Source Leukocytes, and Therapeutic Exchange Plasma intended for further manufacture into injectable drug products (e.g. immune globulin, albumin) and noninjectable products (e.g. in-vitro devices such as blood bank reagents), which are biological products subject to the licensure provisions of Section 351 of the Public Health Service Act (PHS).

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