StacksVerified U.S. regulatory reference

21 CFR §201.24

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The labeling of all systemic drug products intended for human use indicated to treat a bacterial infection, except a mycobacterial infection, must bear the following statements:
  1. (a)At the beginning of the label, under the product name, the labeling must state:
  2. (b)In the “Indications and Usage” section, the labeling must state:
  3. (c)In the “Precautions” section, under the “General” subsection, the labeling must state:
  4. (d)In the “Precautions” section, under the “Information for Patients” subsection, the labeling must state: