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.

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.

21:7.0.1.1.5.1	SUBPART A	Subpart A - Release Requirements
21:7.0.1.1.5.1.1.1	SECTION 610.1	610.1 Tests prior to release required for each lot.
21:7.0.1.1.5.1.1.2	SECTION 610.2	610.2 Requests for samples and protocols; official release.
21:7.0.1.1.5.2	SUBPART B	Subpart B - General Provisions
21:7.0.1.1.5.2.1.1	SECTION 610.9	610.9 Equivalent methods and processes.
21:7.0.1.1.5.2.1.2	SECTION 610.10	610.10 Potency.
21:7.0.1.1.5.2.1.3	SECTION 610.11-610.11a	610.11-610.11a [Reserved]
21:7.0.1.1.5.2.1.4	SECTION 610.12	610.12 Sterility.
21:7.0.1.1.5.2.1.5	SECTION 610.13	610.13 Purity.
21:7.0.1.1.5.2.1.6	SECTION 610.14	610.14 Identity.
21:7.0.1.1.5.2.1.7	SECTION 610.15	610.15 Constituent materials.
21:7.0.1.1.5.2.1.8	SECTION 610.16	610.16 Total solids in serums.
21:7.0.1.1.5.2.1.9	SECTION 610.17	610.17 Permissible combinations.
21:7.0.1.1.5.2.1.10	SECTION 610.18	610.18 Cultures.
21:7.0.1.1.5.3	SUBPART C	Subpart C [Reserved]
21:7.0.1.1.5.4	SUBPART D	Subpart D [Reserved]
21:7.0.1.1.5.4.1.1	SECTION 610.20-610.21	610.20-610.21 [Reserved]
21:7.0.1.1.5.5	SUBPART E	Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections
21:7.0.1.1.5.5.1.1	SECTION 610.39	610.39 Definitions.
21:7.0.1.1.5.5.1.2	SECTION 610.40	610.40 Test requirements.
21:7.0.1.1.5.5.1.3	SECTION 610.41	610.41 Donor deferral.
21:7.0.1.1.5.5.1.4	SECTION 610.42	610.42 Restrictions on use for further manufacture of medical devices.
21:7.0.1.1.5.5.1.5	SECTION 610.44	610.44 Use of reference panels by manufacturers of test kits.
21:7.0.1.1.5.5.1.6	SECTION 610.46	610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
21:7.0.1.1.5.5.1.7	SECTION 610.47	610.47 Hepatitis C virus (HCV) “lookback” requirements.
21:7.0.1.1.5.5.1.8	SECTION 610.48	610.48 [Reserved]
21:7.0.1.1.5.6	SUBPART F	Subpart F - Dating Period Limitations
21:7.0.1.1.5.6.1.1	SECTION 610.50	610.50 Date of manufacture for biological products.
21:7.0.1.1.5.6.1.2	SECTION 610.53	610.53 Dating periods for Whole Blood and blood components.
21:7.0.1.1.5.7	SUBPART G	Subpart G - Labeling Standards
21:7.0.1.1.5.7.1.1	SECTION 610.60	610.60 Container label.
21:7.0.1.1.5.7.1.2	SECTION 610.61	610.61 Package label.
21:7.0.1.1.5.7.1.3	SECTION 610.62	610.62 Proper name; package label; legible type.
21:7.0.1.1.5.7.1.4	SECTION 610.63	610.63 Divided manufacturing responsibility to be shown.
21:7.0.1.1.5.7.1.5	SECTION 610.64	610.64 Name and address of distributor.
21:7.0.1.1.5.7.1.6	SECTION 610.65	610.65 Products for export.
21:7.0.1.1.5.7.1.7	SECTION 610.67	610.67 Bar code label requirements.
21:7.0.1.1.5.7.1.8	SECTION 610.68	610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.