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.