CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 5]

[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 acid	0.1
Palmitic acid	10.0
Palmitoleic acid	0.1
Stearic acid	13.5
Oleic acid	72.0
Linoleic acid	3.8
Linolenic acid	0.1
Arachidic acid	0.5
Behenic acid	0.2

[54 FR 8321, Feb. 28, 1989]