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.

[A1]

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the Help button on the bottom right of each page!

e-CFR data is current as of August 10, 2020

Title 21 → Chapter I → Subchapter A → Part 58

TITLE 21—Food and Drugs

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

SUBCHAPTER A—GENERAL

PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

rule

Subpart A—GENERAL PROVISIONS

§58.1
Scope.
§58.3
Definitions.
§58.10
Applicability to studies performed under grants and contracts.
§58.15
Inspection of a testing facility.
rule

Subpart B—ORGANIZATION AND PERSONNEL

§58.29
Personnel.
§58.31
Testing facility management.
§58.33
Study director.
§58.35
Quality assurance unit.
rule

Subpart C—FACILITIES

§58.41
General.
§58.43
Animal care facilities.
§58.45
Animal supply facilities.
§58.47
Facilities for handling test and control articles.
§58.49
Laboratory operation areas.
§58.51
Specimen and data storage facilities.
rule

Subpart D—EQUIPMENT

§58.61
Equipment design.
§58.63
Maintenance and calibration of equipment.
rule

Subpart E—TESTING FACILITIES OPERATION

§58.81
Standard operating procedures.
§58.83
Reagents and solutions.
§58.90
Animal care.
rule

Subpart F—TEST AND CONTROL ARTICLES

§58.105
Test and control article characterization.
§58.107
Test and control article handling.
§58.113
Mixtures of articles with carriers.
rule

Subpart G—PROTOCOL FOR AND CONDUCT OF A NONCLINICAL LABORATORY STUDY

§58.120
Protocol.
§58.130
Conduct of a nonclinical laboratory study.
rule

Subparts H-I [Reserved]

rule

Subpart J—RECORDS AND REPORTS

§58.185
Reporting of nonclinical laboratory study results.
§58.190
Storage and retrieval of records and data.
§58.195
Retention of records.
rule

Subpart K—DISQUALIFICATION OF TESTING FACILITIES

§58.200
Purpose.
§58.202
Grounds for disqualification.
§58.204
Notice of and opportunity for hearing on proposed disqualification.
§58.206
Final order on disqualification.
§58.210
Actions upon disqualification.
§58.213
Public disclosure of information regarding disqualification.
§58.215
Alternative or additional actions to disqualification.
§58.217
Suspension or termination of a testing facility by a sponsor.
§58.219
Reinstatement of a disqualified testing facility.

Need assistance?