21 CFR
Part 610 General Biological Products Standards
Subpart A - Release Requirements
- § 610.1 Tests prior to release required for each lot 3 × 483
- § 610.2 Requests for samples and protocols; official release
Subpart B - General Provisions
- § 610.9 Equivalent methods and processes
- § 610.10 Potency
- § 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 2 × 483
Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections
- § 610.39 Definitions
- § 610.40 Test requirements 27 × 483
- § 610.41 Donor deferral 14 × 483
- § 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 14 × 483
- § 610.47 Hepatitis C virus (HCV) “lookback” requirements 22 × 483
Subpart F - Dating Period Limitations
- § 610.50 Date of manufacture for biological products
- § 610.53 Dating periods for Whole Blood and blood components 3 × 483
Subpart G - Labeling Standards
- § 610.60 Container label 2 × 483
- § 610.61 Package label
- § 610.62 Proper name; package label; legible type
- § 610.63 Divided manufacturing responsibility to be shown 1 × 483
- § 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