SUBPART A—General Labeling Provisions (§201.1 to §201.26)
- 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.