Code of Federal Regulations

A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR

1. CODE OF FEDERAL REGULATIONS (CFR) DEPT OF PHARMACEUTICAL REGULATORY AFFAIRS REGULATORY ASPECTS OF DRUGS AND COSMETICS N.G.S.M. INSTITUTE OF PHARMACEUTICAL SCIENCES, NITTE (DEEMED TO BE UNIVERSITY) MANGALORE - SWAPNIL D. FERNANDES

2. CONTENTS

3. What is CFR ? The CFR is divided into 50 titles that represent broad areas subject to federal regulation. The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States.

4. Each title is further divided into chapters, subchapters, parts, and sections. A regulation is cited by title, part, and section, e.g. 14 CFR 121.313 (Title 14, Part 121, Section 313). The soft-cover volumes of the CFR are issued each year : 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 The online CFR is a joint project authorized by the publisher, the National Archives and Records Administration's (NARA) Office of the Federal Register (OFR), and the Government Publishing Office (GPO) to provide the public with enhanced access to Government information.

5. HISTORY OF CFR

6. HISTORY OF CFR Franklin D. Roosevelt – 32 nd President of the US. 1935 - Instrumental in passing the Federal Register Act – empowered the National Archives of the US to form an Administrative Committee – publish the Federal Register . The  Federal Register  Act - amended in 1937 to provide a “codification” of all regulations every five years – known as Code of Federal Regulations.

7. HISTORY OF CFR The first edition of the CFR was published in 1938 and included all finalized regulations that were published in the  Federal Register  from March 14, 1936 to June 1, 1938 Beginning in 1963 for some titles and for all titles in 1967, the Office of the Federal Register began publishing yearly revisions. Beginning in 1972 - published revisions were conducted in staggered quarters.

8. CFR TITLE 21

9. CFR TITLE 21 Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Governs food and drugs within the United States for the FDA, DEA, and the ONDCP. In all, 21 CFR consists of 1499 parts. 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

10. CHAPTER I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: 11 Electronic records and electronic signature related. 50 Protection of human subjects in clinical trials. 54 Financial Disclosure by Clinical Investigators. 56 Institutional Review Boards that oversee clinical trials. 58 Good Laboratory Practices (GLP) for nonclinical studies .

11. The 100 series are regulations pertaining to food. The 200 and 300 series are regulations pertaining to pharmaceuticals The 500 series are regulations for animal feeds and animal medications. The 600 series covers biological products. The 700 series includes the limited regulations on cosmetics. The 800 series are for medical devices.

12. The 900 series covers mammography quality requirements enforced by CDRH. The 1000 series covers radiation-emitting device The 1100 series includes updated rules with regards to tobacco products. The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act: Requirements for pasteurization of milk. Sanitation on interstate conveyances.

13. CHAPTER II Notable sections: 1308 — Schedules of controlled substances 1308.03(a) — Administrative Controlled Substances Code Number 1308.11 — List of Schedule I drugs 1308.12 — List of Schedule II drugs 1308.13 — List of Schedule III drugs 1308.14 — List of Schedule IV drugs 1308.15 — List of Schedule V drugs

14. The list of SCHEDULED DRUGS, as a part of the Controlled Substances Act, falls under the drug policy of the United States government. The following findings are required for drugs to be placed in the aforementioned schedules: The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. Administrative Controlled Substances Code Number (ACSCN)

15. CFR in Modern Times There are a number of electronic sources for accessing CFR. For instance - FDsys.gov and the now GovInfo , the official online document repository for the U.S. Government Publishing Office, is fully browsable, searchable, navigable by citation. GPO also maintains an up-to-date “Electronic Code of Federal Regulations (e-CFR)” service which presents CFR sections in their current form with any recent amendments from the  Federal Register already incorporated. The e-CFR service is updated daily and also allows you to separately view appendices and supplements

16. Research Tools in CFR TABLE OF CONTENTS – CFR titles are broken down by chapter, subchapter, and part . Immediately preceding each part is a table of contents for the individual regulations contained within that part . TABLE OF CFR TITLES AND CHAPTERS – Redesignation tables to help trace new location of parts and sections of A regulation LIST OF CFR SECTIONS AFFECTED IN THE VOLUME – List of CFR Sect ions Affected in Each Volume indicates the Type of Change that was made.

17. CONCLUSION The Federal Register and the Code of Federal Regulations replaced the existing system of dual set of regulations and legislations that were in place. Although not perfect, the Federal Register and the CFR appear to have met 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.

18. REFERENCES http://www.llsdc.org/fr-cfr-research-guide (Accessed on 12 th February 2018) Panama Refining Co. v. Ryan, 293 U.S. 388 (1935). Available from: https://supreme.justia.com/cases/federal/us/293/388/case.html Griswold, E.N. Government in ignorance of the law; a plea for better publication of executive legislation. 48 Harv . L. Rev. 198-215 (1934). Available from: https://public.resource.org/48HarvLRev198.pdf CFR - Code of Federal Regulations Title 21. Available from : https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (Accessed on 13 th February 2018) https://en.wikipedia.org/wiki/Title_21_of_the_Code_of_Federal_Regulations (Accessed on 13 th February 2018)