21 C.F.R. PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart A--RELEASE REQUIREMENTS
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Tests prior to release required for each lot.
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Requests for samples and protocols; official release.
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Subpart B--GENERAL PROVISIONS
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Equivalent methods and processes.
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Inactivated influenza vaccine, general safety test.
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Permissible combinations.
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Subpart C--STANDARD PREPARATIONS AND LIMITS OF POTENCY
Subpart D--MYCOPLASMA
Subpart E--TESTING REQUIREMENTS FOR COMMUNICABLE DISEASE AGENTS
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Restrictions on use for further manufacture of medical devices.
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Use of reference panels by manufacturers of test kits.
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''Lookback'' requirements.
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''Lookback'' notification requirements for transfusion services.
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Subpart F--DATING PERIOD LIMITATIONS
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Dating periods for licensed biological products.
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Subpart G--LABELING STANDARDS
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Proper name; package label; legible type.
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Divided manufacturing responsibility to be shown.
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Name and address of distributor.
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Bar code label requirements.
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