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  1. Link to an amendment published at 89 FR 51769, June 18, 2024. ( a) 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.

  2. Mar 22, 2024 · § 211.82 - Receipt and storage of untested components, drug product containers, and closures.

  3. Chapter I. Food and Drug Administration, Department of Health and Human Services. 1 – 1299. Subchapter C. Drugs: General. 200 – 299. Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals. 211.1 – 211.208.

  4. PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

  5. Dec 29, 2023 · The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.

  6. Mar 22, 2024 · PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS. Subpart A - General Provisions. Sec. 211.1 Scope. (a) The regulations in this part contain the minimum current...

  7. ( a) 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.

  8. Each for performance of operations ad-containers dressed by §§211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the product requirements included in those sec-tions relating to the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section, and one person ...

  9. Apr 1, 2011 · 21 CFR 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS. View the most recent version of this document on this website.

  10. LII. Electronic Code of Federal Regulations (e-CFR) Title 21Food and Drugs. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER C—DRUGS: GENERAL. PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS.