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Section 610.1
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Requests for samples and protocols; official release |
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Section 610.2
|
Equivalent methods and processes |
|
Section 610.9
|
Potency |
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Section 610.10
|
General safety |
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Section 610.11
|
Sterility |
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Section 610.12
|
Purity |
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Section 610.13
|
Identity |
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Section 610.14
|
Constituent materials |
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Section 610.15
|
Total solids in serums |
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Section 610.16
|
Permissible combinations |
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Section 610.17
|
Cultures |
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Section 610.18
|
Standard preparations |
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Section 610.20
|
Limits of potency |
|
Section 610.21
|
Test for Mycoplasma |
|
Section 610.30
|
Test requirements |
|
Section 610.40
|
Donor deferral |
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Section 610.41
|
Restrictions on use for further manufacture of medical devices |
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Section 610.42
|
Use of reference panels by manufacturers of test kits |
|
Section 610.44
|
Human immunodeficiency virus (HIV) ``lookback'' requirements |
|
Section 610.46
|
Hepatitis C virus (HCV) ``lookback'' requirements |
|
Section 610.47
|
Hepatitis C virus (HCV) ``lookback'' requirements based on review of historical testing records |
|
Section 610.48
|
Date of manufacture |
|
Section 610.50
|
Dating periods for licensed biological products |
|
Section 610.53
|
Container label |
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Section 610.60
|
Package label |
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Section 610.61
|
Proper name; package label; legible type |
|
Section 610.62
|
Divided manufacturing responsibility to be shown |
|
Section 610.63
|
Name and address of distributor |
|
Section 610.64
|
Products for export |
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Section 610.65
|
Bar code label requirements |
|
Section 610.67
|
Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile |
|
Section 610.68
|
Donor notification |