21 Code of Federal Regulation(21-CFR)

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 1 st  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. (Provide a safe work environment and encourage personal health.)