[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
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.
[[Page 19]]
(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]
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