§ 600.12 Records. The following pages provide more information with respect to regulations for particular product types and manufacturing considerations: 21 CFR Part 600. 600.3 Definitions. As used in this subchapter: (a) Act means the Public Health Service Act (58 Stat. 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. 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. 551-559; 21 U.S.C. PART 800 - GENERAL . Title 21, part 800 of the Electronic Code of Federal Regulations. Meet any additional conditions of … (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. 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) (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]. 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. § 600.3 Definitions. Official Publications from the U.S. Government Publishing Office. 600.12 Records. 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. Compliance Policy Guide Sec. 682), approved July 1, 1944. Home; Title 21 PART 800. Biological Products: General. (a) Maintenance of records. Part 800 - 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. 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. Subpart B - Establishment Standards Sec. 301-399f. '; Toggle navigation eCFR. [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. § 600.81 - Distribution reports. CFR › Title 21 › Volume 8 › Chapter I › Subchapter H › Part 800. terms when used in this part and in Parts 211 through 226 of this chapter. Authority: 5 U.S.C. U.S. Code of Federal Regulations. (1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C.