§§ 610.20--610.21 - [Reserved]

Subpart A - Release Requirements

§ 610.1 - Tests prior to release required for each lot.

§ 610.2 - Requests for samples and protocols; official release.

Subpart B - General Provisions

§ 610.9 - Equivalent methods and processes.

§ 610.10 - Potency.

§ 610.11 - General safety.

§ 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.

§ 610.19 - Status of specific products; Group A streptococcus.

§§ 610.11--610.11a - [Reserved]

§ 610.11a - Inactivated influenza vaccine, general safety test.

Subpart C - XXX

§ 610.20 - Standard preparations.

§ 610.21 - Limits of potency.

Subparts C--D - XXX

Subpart D - Mycoplasma

§ 610.30 - Test for Mycoplasma.

Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections

§ 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.

§ 610.45 - Human Immunodeficiency Virus (HIV) requirements.

§ 610.46 - Human immunodeficiency virus (HIV) “lookback” requirements.

§ 610.47 - Hepatitis C virus (HCV) “lookback” requirements.

§ 610.48 - [Reserved]

Subpart F - Dating Period Limitations

§ 610.50 - Date of manufacture for biological products.

§ 610.53 - Dating periods for Whole Blood and blood components.

Subpart G - Labeling Standards

§ 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.