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Electronic Code of Federal Regulations

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e-CFR Data is current as of July 22, 2014

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
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.
rule

Subpart C—STANDARD PREPARATIONS AND LIMITS OF POTENCY

§610.20
Standard preparations.
§610.21
Limits of potency.
rule

Subpart D—MYCOPLASMA

§610.30
Test for Mycoplasma.
rule

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
Human immunodeficiency virus (HIV) “lookback” requirements.
§610.47
Hepatitis C virus (HCV) “lookback” requirements.
§610.48
Hepatitis C virus (HCV) “lookback” requirements based on review of historical testing records.
rule

Subpart F—DATING PERIOD LIMITATIONS

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

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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