Part 606 — Current Good Manufacturing Practice for Blood and Blood Components
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
Source: 40 FR 53532, Nov. 18, 1975, unless otherwise noted.
Sections
- § 606.3 Definitions.
- § 606.20 Personnel.
- § 606.40 Facilities.
- § 606.60 Equipment.
- § 606.65 Supplies and reagents.
- § 606.100 Standard operating procedures.
- § 606.110 Plateletpheresis, leukapheresis, and plasmapheresis.
- § 606.120 Labeling, general requirements.
- § 606.121 Container label.
- § 606.122 Circular of information.
- § 606.140 Laboratory controls.
- § 606.145 Control of bacterial contamination of platelets.
- § 606.151 Compatibility testing.
- § 606.160 Records.
- § 606.165 Distribution and receipt; procedures and records.
- § 606.170 Adverse reaction file.
- § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.