CODE OF FEDERAL REGULATIONS

CODE OF FEDERAL REGULATIONS

1. CODE OF FEDERAL REGULATIONS SUBMITTED TO : SUBMITTED BY : DR. JAVED ALI ANKIT KUMAR MALIK DEPARTMENT : Pharmaceutics I ST SEMESTER (Pharmaceutics) School Of Pharmaceutical School Of Pharmaceutical Education and Research Education and Research JAMIA HAMDARD JAMIA HAMDARD

2. What is the Code of Federal Regulations(CFR)? The  CODE OF FEDERAL REGULATIONS is the codification of the general and permanent rules and regulations published in the Federal Register by the departments and agencies of the Federal Government of United States. Federal Register is the part of the National Archives and Records Administration. It is also named as ADMINISTRATIVE LAW.

3. The regulations first published in the Federal Register on a daily basis are then codified in the Code of Federal Regulations. The regulations that are published chronologically in the Federal Register are codified and arranged by title, then by chapter (one agency’s regulations) and finally by subject in the CFR. The CFR is published in an unofficial format online on the electronic CFR (e-CFR) website, which is updated daily. The CFR is divided into 50 titles that represent broad areas subject to federal regulation.

4. The CFR is divided into 50 titles, just like the USCA . Agencies are assigned chapters within these titles . Each title is divided into chapters, parts, and sections and paragraphs . For example : 21 CFR 210 211 42 CFR 260.11(a)(1) “42 CFR 260.11(a)(1)” would be read as : Title 42 :- Broad subject area of regulations Part 260 :- Rules on a single program or function Section 11 :- One provision of program/function rules Paragraph (a).(1) :- Detailed, specific requirements

5. Table of contents Title 14 Chapter 1 Parts 60-139 121.313 Subchapter D Part 121

6. New regulations are continually becoming effective, the printed volumes of the CFR are issued once each calendar year, on this schedule: Titles 1–16 are updated as of January 1 Titles 17–27 are updated as of April 1 Titles 28–41 are updated as of July 1 Titles 42–50 are updated as of October 1

7. A FEW VOLUMES OF THE CFR AT A LAW LIBRARY (TITLES 12–26)

8. LIST OF CFR TITLES Title 1: General Provisions Title 2: Grants and Agreements Title 3: The President Title 4: Accounts Title 5: Administrative Personnel Title 6: Domestic Security Title 7: Agriculture Title 8: Aliens and Nationality Title 9: Animals and Animal Products Title 10: Energy Title 11: Federal Elections Title 12: Banks and Banking Title 13: Business Credit and Assistance Title 14 : Aeronautics and Space  (also known as the Federal Aviation Regulations) Title 15: Commerce and Foreign Trade Title 16: Commercial Practices

9. Title 17: Commodity and Securities Exchanges Title 18: Conservation of Power and Water Resources Title 19: Customs Duties Title 20: Employees' Benefits Title 21: Food and Drugs Title 22: Foreign Relations Title 23: Highways Title 24: Housing and Urban Development Title 25: Indians Title 26: Internal Revenue  (also known as the Treasury Regulations) Title 27: Alcohol, Tobacco Products and Firearms Title 28: Judicial Administration Title 29: Labor Title 30: Mineral Resources Title 31: Money and Finance: Treasury Title 32: National Defense Title 33: Navigation and Navigable Waters

10. Title 34: Education Title 35: Reserved   Title 36: Parks, Forests, and Public Property Title 37: Patents, Trademarks, and Copy Title 38: Pensions, Bonuses, and Veterans' Relief Title 39: Postal Service Title 40: Protection of Environment Title 41: Public Contracts and Property Management Title 42: Public Health Title 43: Public Lands: Interior Title 44: Emergency Management and Assistance Title 45: Public Welfare Title 46: Shipping Title 47: Telecommunication Title 48: Federal Acquisition Regulations System Title 49: Transportation Title 50: Wildlife and Fisheries

11. Code of Federal Regulations, seen at the MID-MANHATTAN LIBRARY . Editions of Title 3, on the President, are kept on archive. Notice that for the first year of each new presidency, the volume is thicker.

12. HISTORY The   THE FEDERAL REGISTER ACT originally provided for a complete compilation of all existing regulations prior to the first publication of the  Federal Register , but was amended in 1937 to provide a codification of all regulations every five years. The first edition of the CFR was published in 1938. Beginning in 1963 for some titles and for all titles in 1967, the Office of the Federal Register began publishing yearly revisions.

13. TITLE 21 OF CODE OF FEDERAL REGULATION Title 21  is the portion of the Code of Federal Regulations that governs food and drugs. It is divided into three chapters: Chapter I - FOOD AND DRUG ADMINISTRATION Chapter II – DRUG ENFORCEMENT ADMINISTRATION Chpater III- OFFICE OF NATIONAL DRUG CONTROL POLICY

14. FOOD AND DRUG ADMINISTRATION The  Food and Drug Administration  ( FDA  or  USFDA ) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of :- food safety   tobacco  products  dietary supplements  prescription   over-the-counter pharmaceutical drugs  vaccines and biopharmaceuticals  blood transfusions and medical devices  electromagnetic radiation emitting devices (ERED) cosmetics, animal foods & feed and veterinary products.

15. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.  The FDA has its headquarters in unincorporated White Oak, Maryland .  The agency also has 223 field offices and 13 laboratories located throughout the 50 states.

16. DRUG ENFORCEMENT ADMINISTRATION The  Drug Enforcement Administration  ( DEA ) is a United States federal law enforcement agency under the U.S. Department of Justice, tasked with combating drug smuggling and use within the United States . The DEA is the lead agency for domestic enforcement of the   CONTROLLED SUBSTANCES ACT , sharing concurrent jurisdiction with the Federal Bureau of Investigation (FBI), Immigration and Customs Enforcement (ICE), Homeland Security, and the U.S. Border Patrol . It has sole responsibility for coordinating and pursuing U.S. drug investigations both domestic, and abroad.

17. OFFICE OF NATIONAL DRUG CONTROL POLICY The  Office of National Drug Control Policy  is a component of the Executive Office of the President of the United States . The director evaluates, coordinates, and oversees both the international and domestic anti-drug efforts of executive branch agencies and ensures that such efforts sustain and complement State and local anti-drug activities . The Director advises the President regarding changes in the organization, management, budgeting, and personnel of federal agencies that affect U.S. anti-drug efforts.

18. PROGRAMS OF THE ONDCP The High Intensity Drug Trafficking Areas (HIDTA) program National Youth Anti-Drug Media Campaign World Anti-Doping Agency (WADA)

19. THANK YOU