GroundRules
21 CFR 331.21: Test modifications.
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 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
- Subpart C—Testing Procedures
The formulation or mode of administration of certain products may require a modification of the United States Pharmacopeia 23/National Formulary 18 acid neutralizing capacity test. Any proposed modification and the data to support it shall be submitted as a petition under the rules established in § 10.30 of this chapter. All information submitted will be subject to the disclosure rules in part 20 of this chapter.
Collected 2026-08-27T02:24:47Z. Source file · JSON