[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.24]

[Page 18-19]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201_LABELING--Table of Contents
 
                  Subpart A_General Labeling Provisions
 
Sec. 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.


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    (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.

[68 FR 6081, Feb. 6, 2003]