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[A1]

Electronic Code of Federal Regulations

e-CFR data is current as of July 9, 2020

Title 21 → Chapter I → Subchapter F → Part 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]
rule

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]
rule

Subpart F—DATING PERIOD LIMITATIONS

§610.50
Date of manufacture for biological products.
§610.53
Dating periods for Whole Blood and blood components.
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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