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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 201 - LABELING

21 CFR Part 201 - LABELING

  • CFR
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  1. Subpart A - General Labeling Provisions (§§ 201.1 - 201.26)
  2. Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin (§§ 201.50 - 201.58)
  3. Subpart C - Labeling Requirements for Over-the-Counter Drugs (§§ 201.60 - 201.80)
  4. Subpart D - Exemptions From Adequate Directions for Use (§§ 201.100 - 201.129)
  5. Subpart E - Other Exemptions (§§ 201.150 - 201.161)
  6. Subpart F - Labeling Claims for Drugs in Drug Efficacy Study (§ 201.200)
  7. Subpart G - Specific Labeling Requirements for Specific Drug Products (§§ 201.300 - 201.328)
  8. Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA
Authority:
21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
Source:
40 FR 13998, Mar. 27, 1975, unless otherwise noted.
Editorial Note:
Nomenclature changes to part 201 appear at 69 FR 13717, Mar. 24, 2004.

The following state regulations pages link to this page.



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