The document summarizes Title 21 of the Code of Federal Regulations (CFR), which governs food and drugs in the United States. Title 21 is divided into three chapters covering regulations from the Food and Drug Administration, Drug Enforcement Administration, and Office of National Drug Control Policy. Key parts of Title 21 discussed include Part 11 on electronic records and signatures, Part 210 on current good manufacturing practices for drugs, and Part 211 on manufacturing practices for finished pharmaceuticals. These parts establish requirements for electronic documentation, quality control in drug production, and ensuring drug identity, strength, purity and consistency in manufacturing.

1. DISCUSS ON CFR TITLE 21
OF USFDA.
Prepared by,
Venkatesh Prasath N
M .Pharm 1st yr. (1st Sem)
Dept of Quality Assurance
Guided by,
Dr . B. Babu
Assistant Professor
Dept of Pharmaceutical Analysis.

2. LIST OF CONTENTS
• Introduction
• What is CFR
• eCFR
• History of CFR
• CFR title 21
• Conclusion
• References

3. A system of words, letters, figures, or symbols
used to represent
in an indirect way. Here it denotes as 21”.
Rules published in Federal Register by federal
government of US.
Regulations means general and permanent rules.
CODE
FEDERA
L
REGULATION
S

4. INTRODUCTION
The 21 CFR and its recommendations are very important in
today’s pharmaceutical industry. This CFR is governing of food
and drugs in the United States for three of its governing bodies:
The FDA-Food and Drug Administration.
DEA-Drug Enforcement Agency.
ONDCP-Office of National Drug Control Policy.
The CFR is published by the office of the Federal Register, an
agency of the National Archives and Records Administration
(NARA).
The Code of Federal Regulations (CFR) is the codification of the
general and permanent rules and regulations (sometimes called
as administrative law) published in the Federal Register by the
executive departments and agencies of the federal government
of the United States.
The regulations that are published Chronologically in the Federal
Register are codified are arranged by title, then by chapter ( one
agency’s regulations) and finally by subjects in the CFR

5. HISTORY OF CFR
Franklin D. Roosevelt 32nd President of the US passed the
Federal Register Act in 1935 empowered National Archives of
US to form Administrative Committee publish the Federal
Register.
This Federal Register Act in 1937 to provides “codification” for
every 5 yrs known as Code of Federal Regulations.
1938 - The first edition of the CFR was published.
1963 – There are some titles added to register.
1967 – All titles were added to Federal Register.
1972 – The publish on revisions for register conducted.

6. WHAT IS CFR ?
The Code of Federal Regulations (CFR) is the
codification of the general and permanent rules and
regulations (sometimes called as administrative law)
published in the Federal Register by the governing of
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.
A regulation is cited by title, part, and section E.g. 14
CFR 121.313 (Title 14, Part 121, Section 313).
Chapter
s
Sub-
parts
Parts Sectio
ns
Title

8. eCFR-2017
The Electronic Code of Federal Regulations (eCFR) is a web version
of the Code of Federal Regulations (CFR) that we update daily to
better reflect its current status. The eCFR is an editorial compilation
of the CFR materials and amendments published in the daily Federal
Register.
The Administrative Committee of the Federal Register (ACFR) has
authorized the National Archives and Records Administrative office
of Federal Register (OFR) and the Government Publishing Office
(GPO) to develop and maintain the eCFR as the information
resources.
The is a continuously updated online version of the CFR and it
provides enhanced features that are not part of the published CFR.
ACFR
GPO
OFR

9. The e CFR allows us to,
 Browse the CFR as it existed at any point of time.
 Compare the regulations as they existed at any two dates.
 View timeline of how the CFR contents been changed.
 Search for specific terms.
 Subscribe for the changes in the regulations.
The annual update cycles of CFR:
TITL
ES
1-16 Revised on
JAN 1
17-27 Revised
on APR 1
28-41
Revised on
41-50
Revised on
OCT 1

10. FEDERAL REGISTER
• Published every business day.
• Libraries usually get it about a week or ten days after it is
published.
• Contents are required to be judicially noticed.
• Index issued monthly, cumulates throughout the year.
• Chronological; whole year pages consecutively.

11. CFR TITLE 21
Title 21 of the CFR is reserved for rules of the Food and Drug
Administration.
In all, 21 CFR consists of 1 to 1499 parts:
It is divided into three chapters:
Food and Drug Administration .
Drug Enforcement Administration.
Office of National Drug Control Policy.
Chapter 2
Chapter
1
Chapter
3

12. CHAPTER 1
Most of this regulations are based on the federal Food, Drug, and
Cosmetic Act.
Series 100 are regulates pertaining to food.
Series 200 & 300 are regulates pertaining to pharmaceuticals.
Series 500 are regulates animal feeds & medications.
Series 600 covers biological products.
Series 700 includes the limited regulations on cosmetics.
Series 800 are for medical devices.
Series 900 covers quality requirements enforced by CDRH.
Series 1000 covers radiation-emitting device.
Series 1100 includes updated rules on tobacco products.
Series 1200 consists rules other than food, drug, and cosmetics act.

13. CHAPTER 2
Series 1308 contains schedules of controlled substances.
It includes;
Series 1308.11 for list of schedule I drugs.
Series 1308.12 for list of schedule II drugs.
Series 1308.13 for list of schedule III drugs.
Series 1308.14 for list of schedule IV drugs.
Series 1308.15 for list of schedule V drugs.
It lists the various drugs & substances that the need for controlled and
would require special documentation for selling & buying.
BY (ACSCN) Administrative Controlled Substances Code Number.

14. CHAPTER 3
Series 1405 rules implements for drug–free environment in
workplaces.
It is primarily deals rules with concerning the implementation of
the drug-free environment in govt workplaces.
These includes lists of substances that are not allowed and the
proper tests and procedures that employees at such places have
to undergo.
It also puts down (record something in writing) the rules as to
how often such tests have to be done.

15. MOST PROMINENT WARNING LETTERS FROM USFDA
IN CFR PARTS.

16. 21CFR PART 11- ELECTRONIC RECORD &
ELECTRONIC SIGNATURE.
The electronic records are trustworthy, reliable, and
generally equivalent to paper records.
Records in electronic form that are created, modified,
maintained, achieved, retrieved, or transmitted.
Electronic signatures to be equivalent to full handwritten
signatures, initials, and other general signings… effective
on or after august 20,1997.
Electronic records may be use in lieu of paper records.
Risk factors:
Mishandling and retrieval of electronic data
Inadequate validation
Failure to document digital changes and complaints
Failure to prevent unauthorized access or changes
Failure to have proper controls

17. 21CFR PART 210 -CURRENT GOOD
MANUFACTURING PRACTICES IN MANUFACTURING,
PROCESSING AND PACKING OR HOLDING OF THE DRUG.
To assure the quality is built into the design and
manufacturing process at the every step.
The regulations set forth are “minimum” requirements.
It covers the manufacturing, facilities and controls for
manufacturing, processing, packaging or holding of a
drug product.
Failure comply will render the drug to be adulterated.
The person who is responsible for the failure to comply
shall be subject to the regulatory action.

18. 21CFR PART 211-CURRENT GOOD
MANUFACTURING PRACTICES FOR
FINISHED PHARMACEUTICALS.
Safety -free of any unexpected side effects.
Identity -exactly what in the label claims.
Strength-delivers correct dosage and potency.
Purity -free from physical, biological and chemical
contaminations.
Quality –meet all standards and can be made consistently.
Failure to meet the requirements, shall render the drug
adulterated.
It contains subparts from A to K,

19. CONCLUSION
The federal register and the code of federal regulations
replaced the existing system of dual set of regulations and
legislations.
Although not perfect, the federal register and the cfr appear to
have meet their original purpose of providing the public with a
comprehensive publication vehicle for all the regulations issued
by federal agencies and the president.
The CFR provided a codified form of the regulations, based on
title, chapters and subjects, that streamlined the process of
finding the required regulations and laws for the
pharmaceutical industry and the public in general, thereby
making these guidelines easily accessible.

20. REFERENCES
 CFR – Code of Federal Regulations Title 21. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearc
h.cfm.
 https://en.wikipedia.org/wiki/Title 21 of the Code of Federal
Regulations.
https://www.ecfr.gov.
https://www.pharmaguideline.com/2014/11/fda-forms-issued-
in-inspections.html.
https://www.gpo.gov/fdsys/granule/CFR-2011-title21 - vol4 –
part 211/ content-detail.html.
https://www.iisdc.org/fr-cfr-research-guide.
https://www.law.cornell.edu./cfr/text/21/part-211.
www.pharmamanufacturing.com

21. THANK YOU.