Subpart B - Establishment Standards Sec. As used in this subchapter: (a) Act means the Public Health Service Act (58 Stat. CFR › Title 21 › Volume 8 › Chapter I › Subchapter H › Part 800. (a) Maintenance of records. 301-399f. Home; Title 21 PART 800. 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. 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. [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. 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. Part 800 - General. (b) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. ). § 600.12 Records. '; Toggle navigation eCFR. Title 21, part 800 of the Electronic Code of Federal Regulations. terms when used in this part and in Parts 211 through 226 of this chapter. 301 et seq. (1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 551-559; 21 U.S.C. 160.900 Prescription Drug Marketing Act--Pedigree Requirements under 21 CFR Part 203 [PDF Size 42 kb]. 21 CFR Part 600. 600.3 Definitions. 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. PART 800 - GENERAL . § 600.3 Definitions. § 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) U.S. Code of Federal Regulations. Meet any additional conditions of … 682), approved July 1, 1944. (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. 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. Official Publications from the U.S. Government Publishing Office. 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. The following pages provide more information with respect to regulations for particular product types and manufacturing considerations: Authority: 5 U.S.C. Biological Products: General. Compliance Policy Guide Sec. 600.12 Records.