Code of Federal Regulations (Last Updated: July 5, 2024) |
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 |
§ 331.21 - Test modifications.
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§ 331.21 Test modifications.
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]