Title 21

PART 201 SUBPART A

Subpart A - General Labeling Provisions

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
• 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

21:4.0.1.1.2.1.1.1	SECTION 201.1	201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
21:4.0.1.1.2.1.1.2	SECTION 201.2	201.2 Drugs and devices; National Drug Code numbers.
21:4.0.1.1.2.1.1.3	SECTION 201.5	201.5 Drugs; adequate directions for use.
21:4.0.1.1.2.1.1.4	SECTION 201.6	201.6 Drugs; misleading statements.
21:4.0.1.1.2.1.1.5	SECTION 201.10	201.10 Drugs; statement of ingredients.
21:4.0.1.1.2.1.1.6	SECTION 201.15	201.15 Drugs; prominence of required label statements.
21:4.0.1.1.2.1.1.7	SECTION 201.16	201.16 Drugs; Spanish-language version of certain required statements.
21:4.0.1.1.2.1.1.8	SECTION 201.17	201.17 Drugs; location of expiration date.
21:4.0.1.1.2.1.1.9	SECTION 201.18	201.18 Drugs; significance of control numbers.
21:4.0.1.1.2.1.1.10	SECTION 201.19	201.19 Drugs; use of term “infant”.
21:4.0.1.1.2.1.1.11	SECTION 201.20	201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
21:4.0.1.1.2.1.1.12	SECTION 201.21	201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
21:4.0.1.1.2.1.1.13	SECTION 201.22	201.22 Prescription drugs containing sulfites; required warning statements.
21:4.0.1.1.2.1.1.14	SECTION 201.23	201.23 Required pediatric studies.
21:4.0.1.1.2.1.1.15	SECTION 201.24	201.24 Labeling for systemic antibacterial drug products.
21:4.0.1.1.2.1.1.16	SECTION 201.25	201.25 Bar code label requirements.
21:4.0.1.1.2.1.1.17	SECTION 201.26	201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.

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