terms when used in this part and in Parts 211 through 226 of this chapter. Official Publications from the U.S. Government Publishing Office. § 600.81 - Distribution reports. regulations in 21 CFR Parts 600, 601, 610, 640, 660, 680, and 1271, and CGMP regulations in 21 CFR Part 200, 201, 210 and 211. Home; Title 21 PART 800. (a) Maintenance of records. (1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Biological Products: General. As used in this subchapter: (a) Act means the Public Health Service Act (58 Stat. Authority: 5 U.S.C. Electronic Code of Federal Regulations (e-CFR) Title 21 - Food and Drugs; CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER F - BIOLOGICS; PART 600 - BIOLOGICAL PRODUCTS: GENERAL; Subpart D - Reporting of Adverse Experiences § 600.81 Distribution reports. Several parts of 21 CFR are most applicable to blood establishments, including: 21 CFR 210 (Current Good Manufacturing Practices for drugs in general) 21 CFR 211 (More cGMPs) 21 CFR 600, 601, 606, 630, and 640 (blood specific regulations) 21 CFR 820 (Quality Systems) ). Title 21, part 800 of the Electronic Code of Federal Regulations. The following pages provide more information with respect to regulations for particular product types and manufacturing considerations: § 600.12 Records. Compliance Policy Guide Sec. [Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2020] [CITE: 21CFR600.14] TITLE 21--FOOD AND DRUGS: CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES: SUBCHAPTER F - BIOLOGICS: PART 600 -- BIOLOGICAL PRODUCTS: GENERAL. § 600.3 Definitions. 21 CFR Part 600. 301 et seq. Select a CFR Part Number- Use the drop down arrow to select one of the CFR Part Numbers for Title 21 and select Search Regulations. 682), approved July 1, 1944. '; Toggle navigation eCFR. (b) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated. 301-399f. 600.3 Definitions. (b) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. 160.900 Prescription Drug Marketing Act--Pedigree Requirements under 21 CFR Part 203 [PDF Size 42 kb]. Regulations most recently checked for updates: Jan 10, 2021 All Titles Title 21 Chapter I Part 600 Subpart D - Reporting of Adverse Experiences § 600.80 - Postmarketing reporting of adverse experiences. 551-559; 21 U.S.C. Part 800 - General. Records shall be made, concurrently with the performance, of each step in the manufacture and distribution of products, in such a manner that at any time successive steps in the manufacture and distribution of any lot may be traced by an inspector. Electronic Code of Federal Regulations (e-CFR) Title 21 - Food and Drugs; CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER F - BIOLOGICS; PART 600 - BIOLOGICAL PRODUCTS: GENERAL; Subpart B - Establishment Standards § 600.11 Physical establishment, equipment, animals, and care. CFR › Title 21 › Volume 8 › Chapter I › Subchapter H › Part 800. Meet any additional conditions of … PART 800 - GENERAL . 600.12 Records. Subpart B - Establishment Standards Sec. U.S. Code of Federal Regulations.

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