Part 610 — General Biological Products Standards
Current through Sep 8, 2026
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.
Sections
- § 610.1 Tests prior to release required for each lot.
- § 610.2 Requests for samples and protocols; official release.
- § 610.9 Equivalent methods and processes.
- § 610.10 Potency.
- § 610.11-610.11a [Reserved]
- § 610.12 Sterility.
- § 610.13 Purity.
- § 610.14 Identity.
- § 610.15 Constituent materials.
- § 610.16 Total solids in serums.
- § 610.17 Permissible combinations.
- § 610.18 Cultures.
- § 610.39 Definitions.
- § 610.40 Test requirements.
- § 610.41 Donor deferral.
- § 610.42 Restrictions on use for further manufacture of medical devices.
- § 610.44 Use of reference panels by manufacturers of test kits.
- § 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
- § 610.47 Hepatitis C virus (HCV) “lookback” requirements.
- § 610.48 [Reserved]
- § 610.50 Date of manufacture for biological products.
- § 610.53 Dating periods for Whole Blood and blood components.
- § 610.60 Container label.
- § 610.61 Package label.
- § 610.62 Proper name; package label; legible type.
- § 610.63 Divided manufacturing responsibility to be shown.
- § 610.64 Name and address of distributor.
- § 610.65 Products for export.
- § 610.67 Bar code label requirements.
- § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.