Code
of Federal Regulation (CFR) is the coding system of the general and permanent
rules, laws and regulations in United States. They become official after the
publication in Federal Register by the executive departments and agencies of
the federal government of the United States.
The
CFR is published by the Office of the Federal Register, an agency of the
National Archive and Records Administration.
The
CFR is divided into 50 titles that symbolize different functional areas subject
to Federal Regulation.
CFR
is identifies by the citation, such as 21 CFR 210.1 would be read as, “Title
21, Part 210, Section 1” represent Status
of Current Good Manufacturing Practice Regulations.
While
new regulations are becoming effective constantly the printed volumes of the
CFR are issued once each calendar year, on the following schedule:
Title
1 – 16 are updated on 1 January
Title
17 – 27 are updated on 1 April
Title
28 – 41 are updated on 1 July
Title
42 – 50 are updated on 1 October
As
a Pharmaceutical Professional Title 21 is import for Food and Drugs.
21
CFR is further divided into parts which denote the specific regulation for the
following enlisted categories:
|
Parts
|
Topics
covered
|
|
1 – 100
|
Administrative issue and
protection of Human Subjects
|
|
100
|
Foods
|
|
200
|
Labelling, cGMP and Controlled
substance
|
|
300
|
Drugs for Human Use
|
|
500
|
Drugs for Veterinary Use
|
|
600
|
Biologicals
|
|
700
|
Cosmetics
|
|
800
|
Medical Device
|
|
1000 - 1400
|
Miscellaneous
|
