GroundRules
21 CFR 357.210: Cholecystokinetic active ingredients.
Where this section sits in the code
- 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
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 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
Collected 2026-08-27T02:24:47Z. Source file · JSON