[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: 21CFR201.306]
[Page 79-80]
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. 201.306 Potassium salt preparations intended for oral ingestion by man.
(a) The Food and Drug Administration will initiate no regulatory
action with respect to the continued marketing of coated tablets
containing potassium chloride or other potassium salts which supply 100
milligrams or more of potassium per tablet provided all the following
conditions are met:
(1) Within 30 days from the date of publication of this statement of
policy in the Federal Register:
(i) The labeling of the drug bears the prescription caution
statement quoted in section 503(b)(4) of the Federal Food, Drug, and
Cosmetic Act;
(ii) The labeling on or within the package from which the drug is to
be dispensed bears adequate information for its use by practitioners in
accord with the ``full disclosure'' labeling requirements of Sec.
201.100 of this chapter, including the following warning statement:
Warning--There have been several reports, published and unpublished,
concerning nonspecific small-bowel lesions consisting of stenosis, with
or without ulceration, associated with the administration of enteric-
coated thiazides with potassium salts. These lesions may occur with
enteric-coated potassium tablets alone or when they are used with
nonenteric-coated thiazides, or certain other oral diuretics. These
small-bowel lesions have caused obstruction, hemorrhage, and
perforation. Surgery was frequently required and deaths have occurred.
Based on a large survey of physicians and hospitals, both United States
and foreign, the incidence of these lesions is low, and a causal
relationship in man has not been definitely established. Available
information tends to implicate enteric-coated potassium salts, although
lesions of this type also occur spontaneously. Therefore, coated
potassium-containing formulations should be administered only when
indicated, and should be discontinued immediately if abdominal pain,
distention, nausea, vomiting, or gastrointestinal bleeding occur. Coated
potassium tablets should be used only when adequate dietary
supplementation is not practicable.
(Although the warning statement includes references to enteric-coated
potassium salt preparations, it applies to any capsule or coated tablet
of a potassium salt intended for oral ingestion without prior dilution
with an adequate volume of liquid to preclude gastrointestinal injury.)
(iii) Any other labeling or additional advertising for the drug
conforms to the labeling described in paragraph (a)(1)(ii) of this
section, in accordance with Sec. Sec. 202.1 and 201.100 of this
chapter.
(2) Within 90 days from the date of publication of this statement of
policy in the Federal Register, the manufacturer, packer, or distributor
of the drug shall submit a new-drug application containing satisfactory
information of the kind required by Sec. 314.50 of this chapter, with
appropriate labeling as described in this paragraph.
(b) The Food and Drug Administration may initiate regulatory
proceedings after 30 days from the date of publication of this section,
with respect to the marketing of uncoated tablets containing potassium
chloride or other potassium salts which supply 100 milligrams or more of
potassium per tablet or with respect to liquid preparations containing
potassium chloride or other potassium salts which supply 20 milligrams
or more of potassium per milliliter, labeled or intended for human use,
unless all the following conditions are met:
(1) The labeling of the drug bears the prescription statement quoted
in section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act; and
(2) The labeling on or within the package from which the drug is to
be dispensed bears adequate information for its use by practitioners in
accord with the ``full disclosure'' labeling requirements of Sec.
201.100 of this chapter, including a recommendation that patients be
directed to dissolve any such tablets in an appropriate amount of liquid
and to dilute any such liquid preparations adequately to assure
[[Page 80]]
against gastrointestinal injury associated with the oral ingestion of
concentrated potassium salt preparations.
[40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29, 1990;
67 FR 4906, Feb. 1, 2002]
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