Title 21

PART 610

Part 610 - General Biological Products Standards

PART 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS Authority:21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264. Source:38 FR 32056, Nov. 20, 1973, unless otherwise noted. Cross References:

For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.

21:7.0.1.1.5.1SUBPART A
Subpart A - Release Requirements
21:7.0.1.1.5.1.1.1SECTION 610.1
   610.1 Tests prior to release required for each lot.
21:7.0.1.1.5.1.1.2SECTION 610.2
   610.2 Requests for samples and protocols; official release.
21:7.0.1.1.5.2SUBPART B
Subpart B - General Provisions
21:7.0.1.1.5.2.1.1SECTION 610.9
   610.9 Equivalent methods and processes.
21:7.0.1.1.5.2.1.2SECTION 610.10
   610.10 Potency.
21:7.0.1.1.5.2.1.3SECTION 610.11-610.11a
   610.11-610.11a [Reserved]
21:7.0.1.1.5.2.1.4SECTION 610.12
   610.12 Sterility.
21:7.0.1.1.5.2.1.5SECTION 610.13
   610.13 Purity.
21:7.0.1.1.5.2.1.6SECTION 610.14
   610.14 Identity.
21:7.0.1.1.5.2.1.7SECTION 610.15
   610.15 Constituent materials.
21:7.0.1.1.5.2.1.8SECTION 610.16
   610.16 Total solids in serums.
21:7.0.1.1.5.2.1.9SECTION 610.17
   610.17 Permissible combinations.
21:7.0.1.1.5.2.1.10SECTION 610.18
   610.18 Cultures.
21:7.0.1.1.5.3SUBPART C
Subpart C [Reserved]
21:7.0.1.1.5.4SUBPART D
Subpart D - Mycoplasma
21:7.0.1.1.5.4.1.1SECTION 610.30
   610.30 Test for Mycoplasma.
21:7.0.1.1.5.5SUBPART E
Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections
21:7.0.1.1.5.5.1.1SECTION 610.39
   610.39 Definitions.
21:7.0.1.1.5.5.1.2SECTION 610.40
   610.40 Test requirements.
21:7.0.1.1.5.5.1.3SECTION 610.41
   610.41 Donor deferral.
21:7.0.1.1.5.5.1.4SECTION 610.42
   610.42 Restrictions on use for further manufacture of medical devices.
21:7.0.1.1.5.5.1.5SECTION 610.44
   610.44 Use of reference panels by manufacturers of test kits.
21:7.0.1.1.5.5.1.6SECTION 610.46
   610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
21:7.0.1.1.5.5.1.7SECTION 610.47
   610.47 Hepatitis C virus (HCV) “lookback” requirements.
21:7.0.1.1.5.5.1.8SECTION 610.48
   610.48 [Reserved]
21:7.0.1.1.5.6SUBPART F
Subpart F - Dating Period Limitations
21:7.0.1.1.5.6.1.1SECTION 610.50
   610.50 Date of manufacture for biological products.
21:7.0.1.1.5.6.1.2SECTION 610.53
   610.53 Dating periods for Whole Blood and blood components.
21:7.0.1.1.5.7SUBPART G
Subpart G - Labeling Standards
21:7.0.1.1.5.7.1.1SECTION 610.60
   610.60 Container label.
21:7.0.1.1.5.7.1.2SECTION 610.61
   610.61 Package label.
21:7.0.1.1.5.7.1.3SECTION 610.62
   610.62 Proper name; package label; legible type.
21:7.0.1.1.5.7.1.4SECTION 610.63
   610.63 Divided manufacturing responsibility to be shown.
21:7.0.1.1.5.7.1.5SECTION 610.64
   610.64 Name and address of distributor.
21:7.0.1.1.5.7.1.6SECTION 610.65
   610.65 Products for export.
21:7.0.1.1.5.7.1.7SECTION 610.67
   610.67 Bar code label requirements.
21:7.0.1.1.5.7.1.8SECTION 610.68
   610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.