21 CFR Part 610 — General Biological Products Standards
Subpart A — Release Requirements
Subpart B — General Provisions
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.
- § 610.46— Human immunodeficiency virus (HIV) “lookback” requirements.
- § 610.47— Hepatitis C virus (HCV) “lookback” requirements.
Subpart F — Dating Period Limitations
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.