A

The Code of Federal Regulations (CFR) is the codification

of the general and permanent rules and regulations
(sometimes called administrative law) published in the
Federal Register by the executive departments and agencies
of the federal government of the United States. The CFR is
divided into 50 titles that represent broad areas subject to
federal regulation.
The regulations first published in the Federal Register on a
daily basis are then codified in the Code of Federal
Regulations.
The regulations that are published chronologically in the
Federal Register are codified and arranged by title, then by
chapter (one agency’s regulations) and finally by subject in
the CFR.
 FUNCTIONS OF CFR:-
 (a) Investigate violations of the laws, including the criminal drug laws,
of the United States and collect evidence in cases in which the United
States is or may be a party in interest, except in cases in which such
responsibility is by statute or otherwise exclusively assigned to another
investigative agency. The Director's authority to investigate violations
of and collect evidence in cases involving the criminal drug laws of the
United States is concurrent with such authority of the Administrator of
the Drug Enforcement Administration under § 0.100 of this part

 (b) Conduct the acquisition, collection, exchange, classification and

preservation of fingerprints and identification records from criminal
justice and other governmental agencies, including fingerprints
voluntarily submitted by individuals for personal identification
purposes.
(c) Conduct personnel investigations requisite to the work of
the Department of Justice and whenever required by statute
or otherwise.
(d) Carry out the Presidential directive of September 6, 1939,
as reaffirmed by Presidential directives of January 8, 1943,
July 24, 1950, and December 15, 1953, designating the
Federal Bureau of Investigation to take charge of
investigative work in matters relating to espionage, sabotage,
subversive activities, and related matters, including
investigating any potential violations of the Arms Export
Control Act, the Export Administration Act, the Trading with
the Enemy Act, or the International Emergency Economic
Powers Act, relating to any foreign counterintelligence
matter.
 (e) Establish and conduct law enforcement training
programs to provide training for State and local law
enforcement personnel; operate the Federal Bureau of
Investigation National Academy; develop new
approaches, techniques, systems, equipment, and
devices to improve and strengthen law enforcement and
assist in conducting State and local training programs.
 The CFR is divided into 50 titles, just like the USCA(United
States Code Annotated)(It is the official compilation
and codification of the general and permanent federal statutes of
the United States. It contains 53 titles (Titles 1–54, excepting Title
53, it being reserved). The main edition is published every six years
by the Office of the Law Revision Counsel of the House of
Representatives)
 1. Some titles covering the same subjects are numbered the same
in the CFR and in the USCA; others are not.
 2. Each title is divided into chapters, subchapters, parts, and
sections.
 3.regulation is cited by title, part, and section, e.g. 14 CFR
121.313 (Title 14, Part 121, Section 313).
 The soft-cover volumes of the CFR are issued each year in sets on a staggered, quarterly basis:
◦ Titles 1 – 16 are updated as of January 1
◦ Titles 17 – 27 are updated as of April 1

◦ Titles 29 – 41 are updated as of July 1

◦ Titles 42 – 50 are updated as of October 1

Each new set contains the text of all regulations in force as of the current through date. New
regulations are merged with, and revoked regulations are deleted from, the previous set of regulations.

The colour of each set of volumes is changed every year; a current full set may contain different
coloured volumes, depending on the time of the year.

Title 3, which contains Presidential Proclamations and Executive Orders, is always white.
The Office of the Federal Register also keeps an unofficial, online version of the CFR, the e-CFR, which
is normally updated within two days after changes that have been published in the Federal Register
become effective. The Parallel Table of Authorities and Rules lists rulemaking authority for regulations
codified in the CFR.
 At the beginning of each print issue
 Documents are listed by agencies in alphabetical order
◦ Cross-referenced from Cabinet departments to subordinate agencies
◦ Each agency document is arranged by category
◦ Rules
◦ Proposed Rules
◦ Notices

 Presidential documents are arranged as follows:

◦ Executive Orders
◦ Proclamations(it is an official declaration issued by a person of
authority to make certain announcements known)
◦ Determinations/Memoranda
 e - CFR
 Title 1
- General
Provisions
Title 2 –
Grants and
Agreement
s
 Title 3
- The
President

 Title 4 - Accounts
 Title 5 -
Administrative
Personnel
 Title 6 -
Domestic
Security Title
7 - Agriculture
 Title 19 - Customs Duties
 Title 20 - Employees' Benefits
 Title 21 - Food and Drugs
 Title 22 - Foreign Relations
 Title 23 - Highways

 Title 24 - Housing and Urban Development

 Title 25 - Indians

 Title 26 - Internal Revenue

 Title 27 - Alcohol, Tobacco Products and Firearms

 Title 28 - Judicial Administration(The practices, procedures, and offices that deal with the management of the administrative systems of

the courts. Judicial administration, also referred to as court administration, is concerned with the day-to-day and long-range activities of the

court system.)

 Title 29 - Labor

 Title 30 - Mineral Resources

 Title 31 - Money and Finance: Treasury

 Title 32 - National Defense

 Title 33 - Navigation and Navigable Waters

 Title 34 - Education

 Title 35 - Panama Canal [Reserved]

 Title 36 - Parks, Forests, and Public Property

 Title 37 - Patents, Trademarks, and Copyrights

 Title 38 - Pensions, Bonuses, and Veterans' Relief

 Title 39 - Postal Service

 Title 40 - Protection of Environment

 Title 41 - Public Contracts and Property Management

  • At the front of each CFR volume, look for:

 Tables of contents to all material within the book

 Tables of contents to the title, subtitle(s), chapter(s), and
 subchapter(s) within the book

 • At the back of each CFR volume, look for:

 A table of “Material Approved for Incorporation by

 Reference” (IBR)
 A “Table of CFR Titles and Chapters”
 An “Alphabetical List of Agencies Appearing in the CFR”
 Redesignation Tables
 A “List of CFR Sections Affected
 The CFR database includes all 50 titles.
 The database incorporates all but the most recent changes to
the Code of Federal Regulations.
 There is an approximately two-week lag between publication
of the Final Rule in the Federal Register and incorporation
into the CFR database.
 Historical CFR databases date back to 1984.
• Database identifiers are CFR01, CFR00, CFR99, etc
 SUBPART A GENERAL PROVISIONS
 § 211.1 Scope
 § 211.2 Definitions
 SUBPART B ORGANIZATION AND PERSONNEL
 § 211.22 Responsibilities of quality control unit.
 § 211.25 Personnel qualifications
 § 211.28 Personnel responsibilities.
 § 211.34 Consultants
 § 211.80 General requirements  § 211.100 Written procedures;
 § 211.82 Receipt and storage of untested deviations
components, drug product containers, and
closures.  § 211.101 Charge-in of
 § 211.84 Testing and approval or
components
rejection of components, drug product  § 211.103 Calculation of yield
containers, and closures  § 211.105 Equipment
 § 211.86 Use of approved components, identification
drug product containers, and closures
 § 211.87 Retesting of approved  § 211.110 Sampling and testing
components, drug product containers, and of in-process materials and drug
closures products
 § 211.89 Rejected components, drug  § 211.111 Time limitations on
product containers, and closures production
 § 211.94 Drug product containers and
 § 211.113 Control of
closures
microbiological contamination
SUBPART F PRODUCTION
AND PROCESS CONTROLS