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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2020]
[CITE: 21CFR357.210]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 357 -- MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart C - Cholecystokinetic Drug Products

Sec. 357.210 Cholecystokinetic active ingredients.

The active ingredient of the product consists of any of the following when used within the specified concentration and dosage form established for each ingredient:

(a) 50-percent aqueous emulsion of corn oil.

(b) Hydrogenated soybean oil in a suitable, water-dispersible powder. The hydrogenated soybean oil is food-grade, partially hydrogenated with a melting point of 41 to 43.5 deg.C, an iodine value of 65 to 69, and a fatty acid composition as follows:

Fatty acid Percent composition
Myristic acid0.1
Palmitic acid10.0
Palmitoleic acid0.1
Stearic acid13.5
Oleic acid72.0
Linoleic acid3.8
Linolenic acid0.1
Arachidic acid0.5
Behenic acid0.2

[54 FR 8321, Feb. 28, 1989]

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