TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS
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.
§ 610.11-610.11a - [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.
Subparts C - D [Reserved]
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.
§ 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.
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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.
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