CODE OF FEDERAL REGULATIONS PDF/ PPT

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CODE OF FEDERAL
REGULATIONS

SUBMITTED TO : SUBMITTED BY :

DR. JAVED ALI ANKIT KUMAR MALIK

DEPARTMENT : Pharmaceutics IST SEMESTER (Pharmaceutics)

School Of Pharmaceutical Education and Research

JAMIA HAMDARD

 

What is the Code of Federal Regulations(CFR)?

The CODE OF FEDERAL REGULATIONS is the codification of
the general and permanent rules and regulations published
in the Federal Register by the departments and agencies of
the Federal Government of United States.

Federal Register is the part of the National Archives and
Records Administration.

 It is also named as ADMINISTRATIVE LAW.

 

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.

The CFR is published in an unofficial format online on the
electronic CFR (e-CFR) website, which is updated daily.

The CFR is divided into 50 titles that represent broad areas
subject to federal regulation.

 

HISTORY

The THE FEDERAL REGISTER ACT originally provided for a
complete compilation of all existing regulations prior to the
first publication of the Federal Register, but was amended
in 1937 to provide a codification of all regulations every five
years.

The first edition of the CFR was published in 1938.

Beginning in 1963 for some titles and for all titles in 1967,
the Office of the Federal Register began publishing yearly
revisions.

 

The CFR is divided into 50 titles, just like the USCA .

 Agencies are assigned chapters within these titles .

Each title is divided into chapters, parts, and sections and
paragraphs .

For example : 21 CFR 210 211

42 CFR 260.11(a)(1)

“42 CFR 260.11(a)(1)” would be read as :

Title 42 :-Broad subject area of regulations

Part 260 :- Rules on a single program or function

Section 11 :- One provision of program/function rules

Paragraph (a).(1) :- Detailed, specific requirements

 

Table of contents

Subchapter D
Title 14

Chapter 1

Parts 60-139 Part 121

121.313

 

New regulations are continually becoming effective, the
printed volumes of the CFR are issued once each calendar
year, on this schedule:

Titles 1–16 are updated as of January 1

Titles 17–27 are updated as of April 1

Titles 28–41 are updated as of July 1

Titles 42–50 are updated as of October 1

 

A FEW VOLUMES OF THE CFR AT A LAW LIBRARY (TITLES 12–26)

 

 

LIST OF CFR TITLES
Title 1: General Provisions

Title 2: Grants and Agreements

Title 3: The President

Title 4: Accounts

Title 5: Administrative Personnel

Title 6: Domestic Security

Title 7: Agriculture

Title 8: Aliens and Nationality

Title 9: Animals and Animal Products

Title 10: Energy

Title 11: Federal Elections

Title 12: Banks and Banking

Title 13: Business Credit and Assistance

Title 14: Aeronautics and Space (also known as the Federal Aviation
Regulations)

Title 15: Commerce and Foreign Trade

Title 16: Commercial Practices

 

Title 17: Commodity and Securities Exchanges

Title 18: Conservation of Power and Water Resources

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 (also known as the Treasury Regulations)

Title 27: Alcohol, Tobacco Products and Firearms

Title 28: Judicial Administration

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: Reserved

Title 36: Parks, Forests, and Public Property

Title 37: Patents, Trademarks, and Copy

Title 38: Pensions, Bonuses, and Veterans’ Relief

Title 39: Postal Service

Title 40: Protection of Environment

Title 41: Public Contracts and Property Management

Title 42: Public Health

Title 43: Public Lands: Interior

Title 44: Emergency Management and Assistance

Title 45: Public Welfare

Title 46: Shipping

Title 47: Telecommunication

Title 48: Federal Acquisition Regulations System

Title 49: Transportation

Title 50: Wildlife and Fisheries

 

Code of Federal Regulations, seen at the MID-
MANHATTAN LIBRARY. Editions of Title 3, on the
President, are kept on archive. Notice that for
the first year of each new presidency, the
volume is thicker.

 

TITLE 21 OF CODE OF FEDERAL REGULATION

Title 21 is the portion of the Code of Federal Regulations that governs
food and drugs.

It is divided into three chapters:

Chapter I – FOOD AND DRUG ADMINISTRATION

Chapter II – DRUG ENFORCEMENT ADMINISTRATION

Chpater III- OFFICE OF NATIONAL DRUG CONTROL POLICY

 

 

FOOD AND DRUG ADMINISTRATION

The Food and Drug Administration (FDA or USFDA) is a federal agency of
the United States Department of Health and Human Services. The FDA is
responsible for protecting and promoting public health through the control
and supervision of:-

 food safety

 tobacco products

 dietary supplements

 prescription

 over-the-counter pharmaceutical drugs

 vaccines and biopharmaceuticals

 blood transfusions and medical devices

 electromagnetic radiation emitting devices (ERED)

cosmetics, animal foods & feed and veterinary products.

 

The FDA is led by the Commissioner of Food and Drugs, appointed by
the President with the advice and consent of the Senate.

The FDA has its headquarters in unincorporated White Oak, Maryland.

 The agency also has 223 field offices and 13 laboratories located
throughout the 50 states.

 

DRUG ENFORCEMENT ADMINISTRATION

The Drug Enforcement Administration (DEA) is a United States federal law
enforcement agency under the U.S. Department of Justice, tasked with
combating drug smuggling and use within the United States.

The DEA is the lead agency for domestic enforcement of the CONTROLLED
SUBSTANCES ACT, sharing concurrent jurisdiction with the Federal Bureau
of Investigation (FBI), Immigration and Customs
Enforcement (ICE), Homeland Security, and the U.S. Border Patrol.

It has sole responsibility for coordinating and pursuing U.S. drug
investigations both domestic, and abroad.

 

OFFICE OF NATIONAL DRUG CONTROL POLICY

The Office of National Drug Control Policy is a component of
the Executive Office of the President of the United States.

The director evaluates, coordinates, and oversees both the
international and domestic anti-drug efforts of executive
branch agencies and ensures that such efforts sustain and complement
State and local anti-drug activities.

The Director advises the President regarding changes in the
organization, management, budgeting, and personnel of federal agencies
that affect U.S. anti-drug efforts.

 

PROGRAMS OF THE ONDCP

The High Intensity Drug Trafficking Areas (HIDTA) program

National Youth Anti-Drug Media Campaign

World Anti-Doping Agency (WADA)

 

THANK YOU