e-CFR banner

Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.

Download the Code of Federal Regulations in XML.

Download the Electronic Code of Federal Regulations in XML.

Monthly Title and Part user viewing data for the e-CFR is available for download in CSV format.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[A2]

 

Electronic Code of Federal Regulations

e-CFR data is current as of December 3, 2019

Title 21 → Chapter I → Subchapter F → Part 660

TITLE 21—Food and Drugs

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

SUBCHAPTER F—BIOLOGICS

PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

rule

Subpart A—ANTIBODY TO HEPATITIS B SURFACE ANTIGEN

§660.1
Antibody to Hepatitis B Surface Antigen.
§660.2
General requirements.
§660.3
Reference panel.
§660.4
Potency test.
§660.5
Specificity.
§660.6
Samples; protocols; official release.
rule

Subpart B—[RESERVED]

rule

Subpart C—BLOOD GROUPING REAGENT

§660.20
Blood Grouping Reagent.
§660.21
Processing.
§660.22
Potency requirements with reference preparations.
§660.25
Potency tests without reference preparations.
§660.26
Specificity tests and avidity tests.
§660.28
Labeling.
rule

Subpart D—REAGENT RED BLOOD CELLS

§660.30
Reagent Red Blood Cells.
§660.31
Eligibility of donor.
§660.32
Collection of source material.
§660.33
Testing of source material.
§660.34
Processing.
§660.35
Labeling.
§660.36
Samples and protocols.
rule

Subpart E—HEPATITIS B SURFACE ANTIGEN

§660.40
Hepatitis B Surface Antigen.
§660.41
Processing.
§660.43
Potency test.
§660.44
Specificity.
§660.45
Labeling.
§660.46
Samples; protocols; official release.
rule

Subpart F—ANTI-HUMAN GLOBULIN

§660.50
Anti-Human Globulin.
§660.51
Processing.
§660.52
Reference preparations.
§660.53
Controls for serological procedures.
§660.54
Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
§660.55
Labeling.

Need assistance?