CFR (code of federal regulations) for Mpharm

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1. CFR ( CODE OF FEDERAL REGULATIONS ) Regulatory Affairs (MPH 104T) M.Pharm (Pharmaceutics) Dept- School of pharmaceutical sciences Chhatrapati Shahu ji Maharaj University(CSJMU) Kanpur - Ayush Puri M.Pharm (1 st semester) Session 2024-25

2. Table of content School of Pharmaceutical sciences, CSJM University 2 introduction 2 . History 3 . Key titles 4 . CFR in Pharmaceutical field 6 . Volumes of CFR 7 . Accessing the CFR 8 . Importance 9 . Conclusion 5 . Amendment procedure 10 . References

3. Introduction to 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 U.S. Federal Government. Purpose - To ensure consistency and transparency in federal regulations. Structure- Organized into 50 titles covering broad areas of federal regulation. Every title is divided into chapters, subchapters, parts and sections. School of Pharmaceutical sciences, CSJM University 3

4. History of CFR First CFR was published in 1938 In 1935 - empowered the National Archives of US to form an administrative committee to publish federal register 1937- federal register act amended to provide codification of all rules in every five years – which is called as CODE OF FEDERAL REGULATIONS In early 1963 for few titles and in 1967 for all titles office of federal register started publishing yearly revisions School of Pharmaceutical sciences, CSJM University 4

5. Key Titles School of Pharmaceutical sciences, CSJM University 5 Title 7 Agriculture Title 21 Food and Drugs Title 49 Transportation Title 40 Protection of Environment It contains the principal set of rules and regulations issued by federal agencies regarding agriculture. CFR that governs food and drugs in the United States, It includes regulations for all products, such as pharmaceuticals, veterinary products, medical devices, cosmetics, and foods.  CFR that deals with EPA's mission of protecting human health and the environment. Regulations to all forms of surface transportation and transportation security, including: pipelines; railroads, both passenger and freight railways; waterways; cars, etc.

6. CFR in Pharmaceutical field Title 21 - CFR Title 21 is particularly relevant to the pharmaceutical field Importance - Ensures the safety, efficacy, and quality of pharmaceutical products School of Pharmaceutical sciences, CSJM University 6 Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals Part 312 Investigational New Drug Application Part 320 Bioavailability and Bioequivalence Requirements Some key Subparts

7. Amendment procedure School of Pharmaceutical sciences, CSJM University 7

8. Volumes of CFR CFR is issued each year Titles 1-16 are updated around January 1 Titles 17-21 are updated around April 1 Titles 29-41 are updated around July 1 Titles 42-50 are updated around October 1 Authorities responsible for publishing CFR are National archives and records administration’s (NARA) Office of federal register (OFR) Government publishing office (GPO) School of Pharmaceutical sciences, CSJM University 8

9. Accessing the CFR 1 . Online Resources CFR can be accessed through the eCFR (Electronic Code of Federal Regulations) and GPO (Government Publishing Office). 2 . Libraries and Legal Resources Available in many public and university libraries. School of Pharmaceutical sciences, CSJM University 9

10. Importance of CFR School of Pharmaceutical sciences, CSJM University ‹#› Legal framework CFR represents the body of federal regulations that have the force of law . These regulations are issued by federal agencies Transparency Provides a clear and public record of regulatory requirements and changes. Compliance Ensures businesses, individuals, and entities comply with federal standards. Public Awareness and Access CFR makes it easier for the public to access and understand the rules Regulatory Consistency CFR ensures consistency in the application of federal regulations across the country Administrative Efficiency CFR centralizes regulatory information, which improves administrative efficiency and reduces duplication

11. CONCLUSION Summary CFR plays a critical role in regulating pharmaceuticals to protect public health CFR is published every year by it’s governing bodies The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals Key Takeaways Understanding and adhering to CFR guidelines is essential for pharmacy professionals School of Pharmaceutical sciences, CSJM University 11

12. References “CFR - Code of Federal Regulations Title 21.” Accessdata.Fda.Gov , www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm . Accessed 10 Aug. 2024. Jagadeeswaran , I., Palani, N., & Lakshmanan, G. (2022). FDA-CFR Title 21-Food and Drugs: Parts 800 to 1299. In  Medical Device Guidelines and Regulations Handbook  (pp. 189-236). Cham: Springer International Publishing. Commissioner, Office of the. “Search for FDA Guidance Documents.” U.S. Food and Drug Administration , FDA, www.fda.gov/regulatory-information/search-fda-guidance-documents . Accessed 11 Aug. 2024. “Code of Federal Regulations.” SlideShare , Slideshare , 24 Apr. 2018, www.slideshare.net/slideshow/code-of-federal-regulations/94850793. School of Pharmaceutical sciences, CSJM University 12