21 C.F.R. § 331.21 Test modifications.
Title 21 - Food and Drugs
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. [61 FR 4823, Feb. 8, 1996]
Title 21: Food and Drugs
PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
Subpart C—Testing Procedures
§ 331.21 Test modifications.