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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 21Chapter ISubchapter FPart 610


TITLE 21—Food and Drugs

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

SUBCHAPTER F—BIOLOGICS

PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS

rule

Subpart A—RELEASE REQUIREMENTS

§610.1
Tests prior to release required for each lot.
§610.2
Requests for samples and protocols; official release.
rule

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.
rule

Subpart C—[RESERVED]

§§610.20-610.21
[Reserved]
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Subpart D—MYCOPLASMA

§610.30
Test for Mycoplasma.
rule

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]
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Subpart F—DATING PERIOD LIMITATIONS

§610.50
Date of manufacture for biological products.
§610.53
Dating periods for Whole Blood and blood components.
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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.
§610.68
Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.

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