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201.306 Potassium salt preparations intended for oral ingestion by man.

Home > Regulations > Labeling > 201.306 Potassium salt preparations intended for oral ingestion by man.



[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.306]

[Page 78-79]
 
                        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

[[Page 79]]

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    Warning--There have been several reports, published and unpublished, 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 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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 201, Section 306


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