Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / 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.
§ 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 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 |