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Regulations last checked for updates: Aug 01, 2025
Title 21 - Food and Drugs last revised: Jul 28, 2025
All Titles
Title 21
Chapter I
Part 201
Subpart A - Subpart A—General Labeling Provisions
§ 201.1 - Drugs; name and place of business of manufacturer, packer, or distributor.
§ 201.2 - Drugs and devices; National Drug Code numbers.
§ 201.5 - Drugs; adequate directions for use.
§ 201.6 - Drugs; misleading statements.
§ 201.10 - Drugs; statement of ingredients.
§ 201.15 - Drugs; prominence of required label statements.
§ 201.16 - Drugs; Spanish-language version of certain required statements.
§ 201.17 - Drugs; location of expiration date.
§ 201.18 - Drugs; significance of control numbers.
§ 201.19 - Drugs; use of term “infant”.
§ 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
§ 201.21 - Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
§ 201.22 - Prescription drugs containing sulfites; required warning statements.
§ 201.23 - Required pediatric studies.
§ 201.24 - Labeling for systemic antibacterial drug products.
§ 201.25 - Bar code label requirements.
§ 201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
authority:
21 U.S.C. 321
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42 U.S.C. 216
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source:
40 FR 13998, Mar. 27, 1975, unless otherwise noted.
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