Code of Federal Regulations
- 1. CODE OF FEDERAL REGULATIONS Presented by : Mohit Mahesh Angolka r B.Pharm VIII Semeste r KLE College of Pharmacy, Belagavi CODE OF FEDERAL REGULATIONS
- 2. Introduction to Code of Federal Regulations (CFR) ❖ The Code of Federal Regulations (CFR) is the codi fi cation 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 . ❖ Federal Register is the part of the National Archives and Records Administration . ❖ The CFR annual edition is the general and permanent rules published by the Of fi ce of the Federal Register and the Government Publishing Of fi ce (GPO) . ❖ In addition to this annual edition, the CFR is published in an unof fi cial format online on the Electronic CFR website, which is updated daily. 2
- 3. How it is organized? ❖ The CFR is divided into 50 titles that represents broad areas subject to federal regulations . ❖ Each title is divided into chapters, which usually bear the name of the issuing agency . ❖ Each chapter is further divided into parts that covers speci fi c regulatory areas . ❖ Large parts may be subdivided into subparts . ❖ All parts are organised in sections and most citations to the CFR refer to material at the section level. 3
- 4. Structure of a CFR citation ❖ Title: The numeric value to the left of “CFR ” ❖ Part: The numeric value to the right of “CFR” and preceding the period (“.” ) ❖ Section/subpart: The numeric value to the right of the period (“.”). A subpart is a letter of the alphabet (A-Z) that is used to retrieve an entire subpart of the CFR rather than many individual sections. For example: Subpart E . ❖ Revision year: It represents the year being cited. 4
- 5. ❖ Example : 21 CFR 310.502 Revised as of April 1, 199 7 ❖ Title: 2 1 ❖ Part: 31 0 ❖ Section: 50 2 ❖ Year: 1997 5
- 6. At the beginning, each PART of the CFR contains: 1. Table of contents for that par t 2. Authority for the par t 3. Source note 6
- 7. ❖ If an individual section has separate authority or separate source information, that will be noted at the end of that section. 7
- 8. History of CFR ❖ The Federal Register Act originally provided for a complete compilation of all existing regulations prior to the fi rst publication of the Federal Register, but was amended in 1937 to provide a codi fi cation of all regulations every fi ve years . ❖ The fi rst edition of the CFR was published in 1938 and included all fi nalised 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 of fi ce of the Federal Register began publishing yearly revisions . ❖ Beginning in 1972- published revisions were conducted in staggered quarters. 8
- 9. ❖ The 50 subject matter titles contain one or more individual volumes, which are updated once each calendar year, on a staggered basis . ❖ The annual update cycle is as follows : • Titles 1-16 are revised as of January 1 • Titles 17-27 are revised as of April 1 • Titles 28-41 are revised as of July 1 • Titles 42-50 are revised as of October 1 ❖ The online CFR is a joint project authorized by the publisher, the National Archives and Records Administration’s (NARA) of fi ce of the Federal Register (OFR), and the Government Publishing Of fi ce (GPO) to provide the public with enhanced access to Government information. 9
- 10. ❖ Each new set contains the text of all regulations in force as of the current through date. New regulations are merged with, and revoked regulations are deleted from, the previous set of regulations . ❖ The Of fi ce of the Federal Register also keeps an unof fi cial, online version of the CFR, the e-CFR, which is normally updated within two days after changes that have been published in the Federal Register become effective . ❖ The Parallel Table of Authorities and Rules lists rule making authority for regulations codi fi ed in the CFR. 10
- 11. CFR- Table of Contents ❖ Title 1 - General Provision s ❖ Title 2 - Grants and Agreement s ❖ Title 3 - The Presiden t ❖ Title 4 - Account s ❖ Title 5 - Administrative Personne l ❖ Title 6 - Domestic Securit y ❖ Title 7 - Agricultur e ❖ Title 8 - Aliens and Nationalit y ❖ Title 9 - Animals and Animal Product s ❖ Title 10 - Energ y ❖ Title 11 - Federal Election s ❖ Title 12 - Banks and Bankin g ❖ Title 13 - Business Credit and Assistanc e ❖ Title 14 - Aeronautics and Spac e ❖ Title 15 - Commerce and Foreign Trad e ❖ Title 16 - Commercial Practice s ❖ Title 17 - Commodity and Securities Exchange s ❖ Title 18 - Conservation of Power and Water Resource s ❖ Title 19 - Customs Dutie s ❖ Title 20 - Employees' Bene fi t s ❖ Title 21 - Food and Drug s ❖ Title 22 - Foreign Relation s ❖ Title 23 - Highway s ❖ Title 24 - Housing and Urban Developmen t ❖ Title 25 - Indians ❖ Title 26 - Internal Revenu e ❖ Title 27 - Alcohol, Tobacco Products and Firearm s ❖ Title 28 - Judicial Administratio n ❖ Title 29 - Labo r ❖ Title 30 - Mineral Resource s ❖ Title 31 - Money and Finance: Treasur y ❖ Title 32 - National Defens e ❖ Title 33 - Navigation and Navigable Water s ❖ Title 34 - Educatio n ❖ Title 36 - Parks, Forests, and Public Propert y ❖ Title 37 - Patents, Trademarks, and Copyright s ❖ Title 38 - Pensions, Bonuses, and Veterans' Relie f ❖ Title 39 - Postal Servic e ❖ Title 40 - Protection of Environmen t ❖ Title 41 - Public Contracts and Property Managemen t ❖ Title 42 - Public Healt h ❖ Title 43 - Public Lands: Interio r ❖ Title 44 - Emergency Management and Assistanc e ❖ Title 45 - Public Welfar e ❖ Title 46 - Shippin g ❖ Title 47 - Telecommunicatio n ❖ Title 48 - Federal Acquisition Regulations Syste m ❖ Title 49 - Transportatio n ❖ TItle 50 - Wildlife and Fisheries 11
- 12. Title 21: Food and Drugs Code of Federal Regulations 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 ( F D A ) , t h e D r u g E n f o rc e m e n t Administration (DEA) and the Of fi ce of National Drug Control Policy (ONDCP). 12 ❖ It is divided into three chapters : • Chapter I - Food and Drug Administratio n • Chapter II - Drug Enforcement Administratio n • Chapter III - Of fi ce of National Drug Control Policy
- 13. Chapter I - Food and Drug Administration ❖ The regulations are derived from the Federal Food, Drug and Cosmetics Act . ❖ 21 CFR is generally known for 21 CFR part 11 which deals with rules concerning digital signatures and electronic records maintenance . ❖ This chapter has many sections dealing with various guidelines : 13 Notable sections : • 11 Electronic records and electronic signature relate d • 50 Protection of human subjects in clinical trial s • 54 fi nancial disclosure by Clinical Investigator s • 56 Institutional Review Boards that oversee clinical trial s • 58 Good Laboratory Practices (GLP) for nonclinical studies
- 14. The 100 series - regulations pertaining to foo d • 101.9 Nutritional facts label relate d - (c)(2)(ii) Requirement to include Trans-Fat Value s - (c)(8)(iv) Vitamin and Mineral value s • 106-107 Requirements for infant formul a • 110 et seq. cGMPs for Food Product s • 111 et seq. cGMPs for Dietary Supplement s • 170 Food Additive s • 190 Dietary Supplements 14
- 15. The 200 and 300 series - regulations pertaining to pharmaceuticals : • 202-203 Drug advertising and marketing • 210 et seq. cGMPs for pharmaceutical s • 310 et seq. Requirements for new drug s • 328 et seq. Speci fi c requirements for over-the-counter (OTC) drugs . 15 The 500 series - regulations for animal feeds and animal medications : • 510 et seq. New animal drug s • 556 Tolerances for residues of drugs in food animal s The 600 series - covers biological products (eg. vaccines, blood) : • 601 Licensing under section 351 of the Public Health Service Ac t • 606 et seq. cGMPs for human blood and blood products
- 16. The 700 series - includes the limited regulations on cosmetics : • 701 Labelling requirement s The 800 series - for medical devices : • 803 Medical Device Reportin g • 814 Premarket Approval of Medical Device s • 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO ) • 860 et seq. Listing of speci fi c approved devices and how they are classi fi ed The 900 series - covers mammography quality requirements enforced by CDRH. 16
- 17. The 1000 series - covers radiation-emitting device : • Example includes cell phones, lasers, x-ray generator s • Requirements enforced by the Centre for Devices and Radiological Health . • It also talks about the FDA citizen petition . 17 The 1100 series - includes : • Updated rules deeming items that statutorily come under the de fi nition of “tobacco product” to be subject to the Federal Food, Drugs and Cosmetics Act as amended by the Tobacco Control Act . • The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco.
- 18. The 1200 series - consists of rules primarily based in laws other than the Food, Drug and Cosmetics Act . • 1240 rules promulgated under 361 of the Public Health Services Act on interstate control of communicable disease, such as : - Requirements for pasteurisation of mil k - Interstate shipment of turtles as pets . - Interstate shipment of African rodents that may carry monkeypox. - Sanitation on interstate conveyances ( i.e. airplanes and ships ) • 1271 Requirements for human cells, tissues, and cellular and tissue- based products (i.e. the cGTPs). 18
- 19. Chapter II - Drug Enforcement Administration Notable sections : ❖ 1308 - schedules of controlled substance s • 1308.03(a) Administrative Controlled Substances Code Numbe r • 1308.11 List of Schedule I drug s • 1308.12 List of Schedule II drug s • 1308.13 List of Schedule III drug s • 1308.14 List of Schedule IV drug s • 1308.15 List of Schedule V drugs 19
- 20. Chapter III - Office of National Drug Control Policy ❖ It deals with rules concerning the implementation of a drug-free environment in government workplaces . Notable sectio n • 1405 Government-Wide requirements for Drug-Free workplace s ❖ Programs of the ONDCP : • The High Intensity Drug Traf fi cking Areas (HIDTA) progra m • National Youth Anti-Drug Media Campaig n • World Anti-Doping Agency (WADA) 20
- 21. IND Application Process Regulations ❖ 21 CFR Part 50 Protection of Human Subjects ❖ 21 CFR Part 54 Financial Disclosure by Clinical Investigator s ❖ 21 CFR Part 56 Institutional Review Boards ❖ 21 CFR Part 58 Good Lab Practices for Nonclinical Laboratory (animal) studies ❖ 21 CFR Part 201 Drug Labellin g ❖ 21 CFR Part 312 Investigational New Drug Application ❖ 21 CFR Part 314 INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval) ❖ 21 CFR Part 316 Orphan Drugs 21
- 22. ❖ In September 2010, the Food and Drug Administration issued fi nal regulations addressing the safety reporting requirements for investigational new drug applications (INDs) found in 21 CFR Part 312 and for Bioavailability and Bioequivalence studies found in 21 CFR Part 320 . ❖ This fi nal rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials . ❖ The fi nal rule lays out clear de fi nitions and standards so that critical safety information about Investigational New Drugs will be accurately and rapidly reported to the agency, minimising uninformative reports and enhancing reporting of meaningful, interpretable information. 22
- 23. Research tools in each volume of the CFR 23 ❖ Table of contents listing all material within the book: titles, subtitles, chapters, subchapters, parts and sections . • Subtitles are referenced to page numbers . ❖ Material approved for incorporation by Reference, which is regulatory material not published in the Federal Register or CFR ; • Has force of law as if it were published in the Federal Register and CF R • Mostly technical standards, state law and regulation s ❖ 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 each volume.
- 24. Table of Contents : At the beginning of each print issue : ❖ Documents are listed by agencies in alphabetical orde r • Cross-referenced from Cabinet departments to subordinate agencie s • Each agency document is arranged by categor y - Rule s - Proposed rule s - Notice s ❖ Presidential documents are arranged as follows ; • Executive order s • Proclamations • Determinations/Memoranda 24
- 25. ❖ 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. 25
- 26. ❖ Material approved for incorporation by Reference, which is regulatory material not published in the Federal Register or CFR ; • Has force of law as if it were published in the Federal Register and CF R • Mostly technical standards, state law and regulations 26
- 27. ❖ Table of CFR titles and chapters; • Redesignation tables to help trace new location of parts and sections of a regulation. 27
- 28. ❖ List of CFR sections affected in each volume indicates the type of change that was made. 28
- 29. 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 codi fi ed form of the regulations, based on title, chapters and subjects, that streamlined the process of fi nding the required regulations and laws for the Pharmaceutical industry and public in general, thereby making these guidelines easily accessible. 29
- 30. REFERENCES ❖ CFR- Code of Federal Regulations Title 21. Available form: https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm ❖ CFR Table of Contents https://www.law.cornell.edu/cfr/text ❖ https://www.govinfo.gov/app/details/CFR-2011-title21-vol7/CFR-2011-title21-vol7- part740-toc-id346/context ❖ Introduction to Code of Federal Regulations. Slideshare: https://www.slideshare.net/ AnkitMalik60/cfr-ankit ❖ https://www.slideshare.net/SwapnilFernandes1/code-of-federal-regulations ❖ https://www.slideshare.net/ArabindaChangmai/code-of-federal-regulations-cfr-in- pharmaceutical-88513524 ❖ https://slideplayer.com/amp/2488561/ 30
- 31. THANK YOU