Format & content for new OTC drug products (included FDA recommendations on statutory requirements)

General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

Documents and Forms

Document Name Document Type
FFDCA Sec 502 - 21 USC 352.pdf Other-Statutory Authority
Labeling of nonRx drugs under NDCPA GFI Sept 2009.pdf Other-Agency Guidance

Information Collection (IC) Details