[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: 21CFR201.55]
[Page 21]
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 B Labeling Requirements for Prescription Drugs and/or Insulin
Sec. 201.55 Statement of dosage.
Section 201.100(b)(2) requires that labels for prescription drugs
bear a statement of the recommended or usual dosage. Since the dosage
for some prescription drugs varies within extremely wide limits,
depending upon the conditions being treated, it may not be possible in
all cases to present an informative or useful statement of the
recommended or usual dosage in the space available on the label or
carton of the package. It is the view of the Food and Drug
Administration that when such a situation prevails, compliance with this
requirement would be met by a statement such as ``See package insert for
dosage information'', where the detailed information is contained in
such insert. However, if an informative, realistic, recommended or usual
dosage can readily be set forth on the label, it should appear thereon.
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