CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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 640 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

Subpart A - Whole Blood
   § 640.1 - Whole Blood.
   § 640.2 - General requirements.
   § 640.4 - Collection of the blood.
   § 640.5 - Testing the blood.
   § 640.6 - Modifications of Whole Blood.

Subpart B - Red Blood Cells
   § 640.10 - Red Blood Cells.
   § 640.11 - General requirements.
   § 640.12 - Eligibility of donor.
   § 640.13 - Collection of the blood.
   § 640.14 - Testing the blood.
   § 640.15 - Segments for testing.
   § 640.16 - Processing.
   § 640.17 - Modifications for specific products.

Subpart C - Platelets
   § 640.20 - Platelets.
   § 640.21 - Eligibility of donors.
   § 640.22 - Collection of source material.
   § 640.23 - Testing the blood.
   § 640.24 - Processing.
   § 640.25 - General requirements.

Subpart D - Plasma
   § 640.30 - Plasma.
   § 640.31 - Eligibility of donors.
   § 640.32 - Collection of source material.
   § 640.33 - Testing the blood.
   § 640.34 - Processing.

Subpart E [Reserved]

Subpart F - Cryoprecipitate
   § 640.50 - Cryoprecipitated AHF.
   § 640.51 - Eligibility of donors.
   § 640.52 - Collection of source material.
   § 640.53 - Testing the blood.
   § 640.54 - Processing.
   § 640.55 - U.S. Standard preparation.
   § 640.56 - Quality control test for potency.

Subpart G - Source Plasma
   § 640.60 - Source Plasma.
   § 640.64 - Collection of blood for Source Plasma.
   § 640.65 - Plasmapheresis.
   § 640.66 - Immunization of donors.
   § 640.67 - Laboratory tests.
   § 640.68 - Processing.
   § 640.69 - General requirements.
   § 640.71 - Manufacturing responsibility.
   § 640.72 - Records.
   § 640.73 - Reporting of fatal donor reactions.
   § 640.74 - Modification of Source Plasma.
   § 640.76 - Products stored or shipped at unacceptable temperatures.

Subpart H - Albumin (Human)
   § 640.80 - Albumin (Human).
   § 640.81 - Processing.
   § 640.82 - Tests on final product.
   § 640.83 - General requirements.
   § 640.84 - Labeling.

Subpart I - Plasma Protein Fraction (Human)
   § 640.90 - Plasma Protein Fraction (Human).
   § 640.91 - Processing.
   § 640.92 - Tests on final product.
   § 640.93 - General requirements.
   § 640.94 - Labeling.

Subpart J - Immune Globulin (Human)
   § 640.100 - Immune Globulin (Human).
   § 640.101 - General requirements.
   § 640.102 - Manufacture of Immune Globulin (Human).
   § 640.103 - The final product.
   § 640.104 - Potency.

Subpart K [Reserved]

Subpart L - Alternative Procedures
   § 640.120 - Alternative procedures.

Subpart M - Definitions and Medical Supervision
   § 640.125 - Definitions.
   § 640.130 - Medical supervision.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.
Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.