[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: 21CFR201.304]
[Page 77-78]
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. 201.304 Tannic acid and barium enema preparations.
(a) It has become a widespread practice for tannic acid to be added
to barium enemas to improve X-ray pictures. Tannic acid is capable of
causing diminished liver function and severe liver necrosis when
absorbed in sufficient amounts. The medical literature reports a number
of deaths associated with the addition of tannic acid to barium enemas.
There is a lack of scientific evidence to establish the conditions, if
any, under which tannic acid is safe and effective for use in enemas.
Tannic acid for rectal use to enhance X-ray visualization is regarded as
a new drug within the meaning of section 201(p) of the Federal Food,
Drug, and Cosmetic Act.
(b) In view of the hazards involved when tannic acid is used in
barium enemas, any shipments of tannic acid labeled to come within the
exemptions under 502(f) of the Act containing such phrases as:
``Caution: For manufacturing, processing, or repackaging,'' ``For
prescription compounding,'' or ``Diagnostic reagent--For professional
use only'' will be regarded by the Commissioner of Food and Drugs as
misbranded within the meaning of section 502(f) of the Federal Food,
Drug, and Cosmetic Act unless the label and the labeling bear
conspicuously a warning to the effect: ``Warning-- Not for use in
enemas.''
(c) Any tannic acid intended for use by man and found within the
jurisdiction of the Federal Food, Drug, and Cosmetic Act labeled
contrary to this section after 60 days from the date of
[[Page 78]]
its publication in the Federal Register may be made the subject of
regulatory proceedings.
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