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Part 610
FEDERAL · 21 CFR
Part 610 — General Biological Products Standards
30 sections · Title 21: Food and Drugs
§ 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
§ 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
§ 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.