21 C.F.R. § 201.24

Current through September 30, 2024

Section 201.24 - Labeling for systemic antibacterial drug products

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:

(a) At the beginning of the label, under the product name, the labeling must state:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of (insert name of antibacterial drug product) and other antibacterial drugs, (insert name of antibacterial drug product) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

(b) In the "Indications and Usage" section, the labeling must state:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of (insert name of antibacterial drug product) and other antibacterial drugs, (insert name of antibacterial drug product) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

(c) In the "Precautions" section, under the "General" subsection, the labeling must state:

Prescribing (insert name of antibacterial drug product) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

(d) In the "Precautions" section, under the "Information for Patients" subsection, the labeling must state:

Patients should be counseled that antibacterial drugs including (insert name of antibacterial drug product) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When (insert name of antibacterial drug product) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by (insert name of antibacterial drug product) or other antibacterial drugs in the future.

21 C.F.R. §201.24

68 FR 6081, Feb. 6, 2003