21 Code of Federal Regulation(21-CFR)

1. 21 Code of Federal Regulation(21-CFR)
Federal Govt. System in USA
Relating to a system of government in which several
states form a unity but remain independent in internal
affairs.
CFR:
The Code of Federal Regulations (CFR) is a codification
of the general and permanent rules published in the
Federal Register by the Executive departments and
agencies of the Federal Government.

2. 21 CFR is widely followed in pharmaceutical companies
and has great importance in digital documentation.
21 CFR Part 11 is well known in pharmaceuticals.
Title 21 of the CFR is reserved for rules of the Food
and Drug Administration.

3. • The CFR is divided into 50 titles that represent broad
areas subject to federal regulation.
• Each title is further divided into parts, and sections.
• e.g. 21 CFR 11.502
• Title: 21
• Part: 11
• Section: 502
• Since,A regulation is cited by title, part, and section,

4. The annual update cycle of CFR
 Each title (or volume) of the CFR is revised once each
calendar year.
 A revised Title 21 is issued on approximately April 1st of
each year.
• The annual update cycle of CFR is as follows
• 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

5. • Governing bodies of 21 CFR
• Title 21 of the CFR or the Code of Federal Regulations
deals with 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) and
• ONDCP (Office of National Drug Control Policy).

6. • 21 CFR part 11 is generally known for electronic
signature.(data in digital form)
• Electronic Record: maintaining digital form of data
that is created, modified, maintained, archived, retrieved
or distributed by a computer.
• Electronic Signature: A compilation of any symbol(s)
executed to be the legally binding equivalent of an
individual’s handwritten signature.

7. • 21 CFR Part 11 is a section in the Code of Federal
Regulations (CFR) that sets forth the United States Food
and Drug Administration’s (FDA) guidelines on using
electronic records and electronic signatures.
• Each title of the CFR addresses a different regulated
area, 21 CFR relates to Pharmaceuticals and Medical
Devices and Part 11 being applicable to electronic
records and electronic signatures.

8. Chapters in 21 CFR
• The first edition of the CFR was published in 1938.
• Title 21 of the CFR is reserved for rules of the Food and
Drug Administration.
• It is divided into three chapters:
Chapter I — Food and Drug Administration,
Chapter II — Drug Enforcement Administration
Chapter III — Office of National Drug Control Policy

9. • Chapter 1
• This chapter is specifically meant for the Food and
Drug Administration (FDA). It has been derived from
the Federal food, drug and cosmetic act.This chapter has
many sections dealing with various guidelines. Some of
the most prominent ones are as follows:
• 21CFR Part11
• 11: Deals with rules concerning digital signatures and
electronic records maintenance. The next few sections
deal with clinical trials. It has FDA 21 CFR part 11
requirements.

10. • 21 CFR Part11 sections:
• 50: Rules to protect human subjects in clinical trials.
• 54: Full disclosure of financial records by such clinical
investigators.
• 56: Guidelines for institutional review boards that
supervise such clinical trials.
• 58: Good Laboratory Practices.

11. • The series in the 100 range relates to food.
• 101: It deals with the listing of nutritional values of
various food items with nutritional elements such as
trans-fat.
• The rest of the 100 series deals with specific food
products such as infant formula, food additives,
dietary supplements, etc.
• The 200 and 300 series deals with how drugs are
advertised and guidelines to over the counter drugs
and good workplace practices.

12. • The 500 series is similar to the 200 and 300 series but deals
specifically with drugs and medications meant for
animals and practices related to the veterinary sciences.
• The 600 series covers biological substances both natural
such as blood and lymph and man-made such a vaccines.
• The 700 series involves everything from labeling to
research involving cosmetics.
• The 800 series is meant for medical devices, their hazard
warnings, approvals needed before launching such a product
and other safety regulations for such devices.

13. • The 900 series regulates the devices and the standards
necessary for devices used for mammography.
• The 1000 series enforces requirements of devices that emit
radiations such as mobile phones, x-ray machines, etc.
• The 1100 series deals with tobacco products and expands
upon the products that previously were not well defined and
covered under tobacco products such as e-cigarettes, pipe
tobacco, etc.
• The 1200 series deals with rules not included in the food,
drug and cosmetic act. Some examples are pasteurization of
milk etc.

14. Chapter 2
• This part of the 21 CFR concerns with the marketing,
sale and use of controlled substances and scheduled
drugs.
• It lists the various drugs and substances that need to be
controlled and would require special documentation for
buying and selling.
• E-cigarette users who use devices that contain nicotine
are exposed to its potentially harmful effects.
• E-cigarettes typically have a heating element that
atomizes a liquid solution called e-liquid.

15. Chapter 3
• It primarily deals with rules concerning the
implementation of a drug-free environment in
government workplaces.
• These include 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.