§ 331.21. Test modifications.
72 words·~1 min read·
/us/cfr/t21/s§ 331.21A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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]