[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: 21CFR201.317]
[Page 85]
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 G Specific Labeling Requirements for Specific Drug Products
Sec. 201.317 Digitalis and related cardiotonic drugs for human use in oral
dosage forms; required warning.
(a) Digitalis and related cardiotonic drugs for human use in oral
dosage forms have been promoted for, and continue to be dispensed and
prescribed for, use in the treatment of obesity, although their safety
and effectiveness for that use have never been established.
(b) Digitalis and related cardiotonic drugs for human use in oral
dosage forms are misbranded within the meaning of section 502 of the
Federal Food, Drug, and Cosmetic Act unless their labeling bears the
following boxed warning at the beginning of the ``Warnings'' section:
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Digitalis alone or with other drugs has been used in the
treatment of obesity. This use of digoxin or other digitalis
glycosides is unwarranted. Moreover, since they may cause
potentially fatal arrhythmias or other adverse effects, the
use of these drugs in the treatment of obesity is dangerous.
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(c) This section does not apply to digoxin products for oral use,
which shall be labeled according to the requirements of Sec. 310.500 of
this chapter.
[43 FR 22009, May 23, 1978]
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