Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

TEXT PDF610.1 Tests prior to release required for each lot.
TEXT PDF610.2 Requests for samples and protocols; official release.
TEXT PDF610.9 Equivalent methods and processes.
TEXT PDF610.10 Potency.
TEXT PDF610.11 General safety.
TEXT PDF610.11a Inactivated influenza vaccine, general safety test.
TEXT PDF610.12 Sterility.
TEXT PDF610.13 Purity.
TEXT PDF610.14 Identity.
TEXT PDF610.15 Constituent materials.
TEXT PDF610.16 Total solids in serums.
TEXT PDF610.17 Permissible combinations.
TEXT PDF610.18 Cultures.
TEXT PDF610.20 Standard preparations.
TEXT PDF610.21 Limits of potency.
TEXT PDF610.30 Test for Mycoplasma.
TEXT PDF610.40 Test requirements.
TEXT PDF610.41 Donor deferral.
TEXT PDF610.42 Restrictions on use for further manufacture of medical devices.
TEXT PDF610.44 Use of reference panels by manufacturers of test kits.
TEXT PDF610.46 Human immunodeficiency virus (HIV) ``lookback'' requirements.
TEXT PDF610.47 Hepatitis C virus (HCV) ``lookback'' requirements.
TEXT PDF610.48 Hepatitis C virus (HCV) ``lookback'' requirements based on review of historical testing records.
TEXT PDF610.50 Date of manufacture.
TEXT PDF610.53 Dating periods for licensed biological products.
TEXT PDF610.60 Container label.
TEXT PDF610.61 Package label.
TEXT PDF610.62 Proper name; package label; legible type.
TEXT PDF610.63 Divided manufacturing responsibility to be shown.
TEXT PDF610.64 Name and address of distributor.
TEXT PDF610.65 Products for export.
TEXT PDF610.67 Bar code label requirements.
TEXT PDF610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.

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