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

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Subpart A--RELEASE REQUIREMENTS

�610.1
Tests prior to release required for each lot.
�610.2
Requests for samples and protocols; official release.
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Subpart B--GENERAL PROVISIONS

�610.9
Equivalent methods and processes.
�610.10
Potency.
�610.11
General safety.
�610.11a
Inactivated influenza vaccine, general safety test.
�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.
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Subpart C--STANDARD PREPARATIONS AND LIMITS OF POTENCY

�610.20
Standard preparations.
�610.21
Limits of potency.
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Subpart D--MYCOPLASMA

�610.30
Test for
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Subpart E--TESTING REQUIREMENTS FOR COMMUNICABLE DISEASE AGENTS

�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
''Lookback'' requirements.
�610.47
''Lookback'' notification requirements for transfusion services.
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Subpart F--DATING PERIOD LIMITATIONS

�610.50
Date of manufacture.
�610.53
Dating periods for licensed biological products.
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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.
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