Code of Federal Regulations · Subpart

Subpart B — Administrative Procedures

21 C.F.R. pt. 330, subpt. B

• § 330.10 Procedures For Classifying Otc Drugs As Generally Recognized As Safe And Effective And Not Misbranded, And For Establishing Monographs
• § 330.11 Nda Deviations From Applicable Monograph
• § 330.12 Status Of Over-the-counter (otc) Drugs Previously Reviewed Under The Drug Efficacy Study (desi)
• § 330.13 Conditions For Marketing Ingredients Recommended For Over-the-counter (otc) Use Under The Otc Drug Review
• § 330.14 Additional Criteria And Procedures For Classifying Otc Drugs As Generally Recognized As Safe And Effective And Not Misbranded
• § 330.15 Timelines For Fda Review And Action On Time And Extent Applications And Safety And Effectiveness Data Submissions