§201.24. Labeling for systemic antibacterial drug products.
21 C.F.R. § 201.24
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:
At the beginning of the label, under the product name, the labeling must state:
In the “Indications and Usage” section, the labeling must state:
In the “Precautions” section, under the “General” subsection, the labeling must state:
In the “Precautions” section, under the “Information for Patients” subsection, the labeling must state:
Notes, amendments, and revision history
Amendments
[68 FR 6081, Feb. 6, 2003]
Authority
Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
Source
Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
Amendments
[68 FR 6081, Feb. 6, 2003]