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21-CODE CODE OF FEDERAL REGULATIONS (CFR)

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The Code of Federal Regulations (CFR) is the codification of all general and permanent rules published in the Federal Register by executive branch agencies of the U.S. federal government. It is divided into 50 titles according to broad subject areas, which are further divided into chapters, parts, and sections. Title 21 governs food and drugs and is divided into 3 chapters covering the FDA, DEA, and ONDCP. The CFR provides regulations for areas like pharmaceuticals, medical devices, radiation-emitting devices, and tobacco. It also gives research tools like tables of contents and lists of affected sections to help navigate regulations.

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Code of Federal Regulations (CFR) The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States. The CFR annual edition is the codification of the general and permanent rules published by the Office of the Federal and the Government Publishing Office. In addition to this annual edition, the CFR is published in an unofficial format online on the Electronic CFR website, which is updated daily. The regulations that are published orderly in the Federal Register are codified and arranged by title, then by chapter (one agencys regulations) and finally by subject in the CFR. The CFR is divided into 50 titles which represent broad areas subject to federal regulation. Each title is divided into chapters, subchapters, parts, and sections. A regulation is cited by title, part, and section, e.g. 14 CFR 121.313 (Title14, 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. 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. CFR in pharmaceuticals:- Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: A. Chapter I Food & Drug administration B. Chapter II Drug Enforcement Administration C. Chapter III Office of National Drug Control Policy A. Chapter I Food & Drug administration a) Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. b) 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
c) The 100 series are regulations pertaining to food. d) The 200 and 300 series are regulations pertaining to pharmaceuticals e) The 500 series are regulations for animal feeds and animal medications. f) The 600 series covers biological products. g) The 700 series includes the limited regulations on cosmetics. h) The 800 series are for medical devices. i) The 900 series covers mammography quality requirements enforced by CDRH. j) The 1000 series covers radiation-emitting device k) The 1100 series includes updated rules with regards to tobacco products. l) The 1200 series consists of rules primarily based in laws other than the Food B. Chapter II Drug Enforcement Administration 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 C. Chapter III Office of National Drug Control Policy Notable sections: 1405 Governmentwide requirements for drug-free workplaces. Research Tools in CFR:- 1. 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 . 2. TABLE OF CFR TITLES AND CHAPTERS Resignation tables to help trace new location of parts and sections of A regulation. 3. 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. Goal: -you will have a basic understanding of the regulations governing gmps. Benefits: - Mfger & researcher are the able to interpret & apply regulation in ways that may warks. Risk: - The flexibility may lead to confusion during the interpretation of the regulations & misapplied control mechanism.

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21-CODE CODE OF FEDERAL REGULATIONS (CFR)

  • 1. Code of Federal Regulations (CFR) The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States. The CFR annual edition is the codification of the general and permanent rules published by the Office of the Federal and the Government Publishing Office. In addition to this annual edition, the CFR is published in an unofficial format online on the Electronic CFR website, which is updated daily. The regulations that are published orderly in the Federal Register are codified and arranged by title, then by chapter (one agencys regulations) and finally by subject in the CFR. The CFR is divided into 50 titles which represent broad areas subject to federal regulation. Each title is divided into chapters, subchapters, parts, and sections. A regulation is cited by title, part, and section, e.g. 14 CFR 121.313 (Title14, 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. 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. CFR in pharmaceuticals:- Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: A. Chapter I Food & Drug administration B. Chapter II Drug Enforcement Administration C. Chapter III Office of National Drug Control Policy A. Chapter I Food & Drug administration a) Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. b) 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
  • 2. c) The 100 series are regulations pertaining to food. d) The 200 and 300 series are regulations pertaining to pharmaceuticals e) The 500 series are regulations for animal feeds and animal medications. f) The 600 series covers biological products. g) The 700 series includes the limited regulations on cosmetics. h) The 800 series are for medical devices. i) The 900 series covers mammography quality requirements enforced by CDRH. j) The 1000 series covers radiation-emitting device k) The 1100 series includes updated rules with regards to tobacco products. l) The 1200 series consists of rules primarily based in laws other than the Food B. Chapter II Drug Enforcement Administration 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 C. Chapter III Office of National Drug Control Policy Notable sections: 1405 Governmentwide requirements for drug-free workplaces. Research Tools in CFR:- 1. 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 . 2. TABLE OF CFR TITLES AND CHAPTERS Resignation tables to help trace new location of parts and sections of A regulation. 3. 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. Goal: -you will have a basic understanding of the regulations governing gmps. Benefits: - Mfger & researcher are the able to interpret & apply regulation in ways that may warks. Risk: - The flexibility may lead to confusion during the interpretation of the regulations & misapplied control mechanism.