CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS

PART 606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

Subpart A - General Provisions
   § 606.3 - Definitions.

Subpart B - Organization and Personnel
   § 606.20 - Personnel.

Subpart C - Plant and Facilities
   § 606.40 - Facilities.

Subpart D - Equipment
   § 606.60 - Equipment.
   § 606.65 - Supplies and reagents.

Subpart E [Reserved]

Subpart F - Production and Process Controls
   § 606.100 - Standard operating procedures.
   § 606.110 - Plateletpheresis, leukapheresis, and plasmapheresis.

Subpart G - Additional Labeling Standards for Blood and Blood Components
   § 606.120 - Labeling, general requirements.
   § 606.121 - Container label.
   § 606.122 - Circular of information.

Subpart H - Laboratory Controls
   § 606.140 - Laboratory controls.
   § 606.145 - Control of bacterial contamination of platelets.
   § 606.151 - Compatibility testing.

Subpart I - Records and Reports
   § 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.

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.