21 CFR 357.210 - Cholecystokinetic active ingredients.

Code of Federal Regulations - Title 21: Food and Drugs

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER D: DRUGS FOR HUMAN USE

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

Subpart C: Cholecystokinetic Drug Products

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 ?C, an iodine value of 65 to 69, and a fatty acid composition as follows:

Fatty acidPercent 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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