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

21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

  • CFR
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  1. Subpart A—General Provisions (§§ 211.1 - 211.3)
  2. Subpart B—Organization and Personnel (§§ 211.22 - 211.34)
  3. Subpart C—Buildings and Facilities (§§ 211.42 - 211.58)
  4. Subpart D—Equipment (§§ 211.63 - 211.72)
  5. Subpart E—Control of Components and Drug Product Containers and Closures (§§ 211.80 - 211.94)
  6. Subpart F—Production and Process Controls (§§ 211.100 - 211.115)
  7. Subpart G—Packaging and Labeling Control (§§ 211.122 - 211.137)
  8. Subpart H—Holding and Distribution (§§ 211.142 - 211.150)
  9. Subpart I—Laboratory Controls (§§ 211.160 - 211.176)
  10. Subpart J—Records and Reports (§§ 211.180 - 211.198)
  11. Subpart K—Returned and Salvaged Drug Products (§§ 211.204 - 211.208)
Authority:
21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
Link to an amendment published at 89 FR 51769, June 18, 2024.
Source:
43 FR 45077, Sept. 29, 1978, unless otherwise noted.

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