21 CFR Part 201 - LABELING
- Subpart A—General Labeling Provisions (§§ 201.1 - 201.26)
- Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin (§§ 201.50 - 201.58)
- Subpart C—Labeling Requirements for Over-the-Counter Drugs (§§ 201.60 - 201.80)
- Subpart D—Exemptions From Adequate Directions for Use (§§ 201.100 - 201.130)
- Subpart E—Other Exemptions (§§ 201.150 - 201.161)
- Subpart F—Labeling Claims for Drugs in Drug Efficacy Study (§ 201.200)
- Subpart G—Specific Labeling Requirements for Specific Drug Products (§§ 201.300 - 201.328)
- 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.
Link to an amendment published at 89 FR 51767, June 18, 2024.
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.