21 CFR Part 201, Subpart A - General Labeling Provisions
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- § 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.