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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 201Subpart D - Subpart D—Exemptions From Adequate Directions for Use
§ 201.100 - Prescription drugs for human use.
§ 201.105 - Veterinary drugs.
§ 201.115 - New drugs or new animal drugs.
§ 201.116 - Drugs having commonly known directions.
§ 201.117 - Inactive ingredients.
§ 201.119 - In vitro diagnostic products.
§ 201.120 - Prescription chemicals and other prescription components.
§ 201.122 - Drugs for processing, repacking, or manufacturing.
§ 201.125 - Drugs for use in teaching, law enforcement, research, and analysis.
§ 201.127 - Drugs; expiration of exemptions.
§ 201.128 - Meaning of “intended uses”.
§ 201.129 - Drugs; exemption for radioactive drugs for research use.
§ 201.130 - Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
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