Laxative Drug Products for Over-the-Counter Human Use; Partial Withdrawal of Proposed Amendment to the Tentative Final Monograph; Intent to Repropose

Zusammenfassung

The Food and Drug Administration (FDA) is withdrawing that part of the notice of proposed rulemaking that would have amended the tentative final monograph for over-the-counter (OTC) laxative drug products to include additional professional labeling for oral and rectal dibasic sodium phosphate/monobasic sodium phosphate (sodium phosphates) drug products. The agency intends to repropose the professional labeling for these products in a future issue of the Federal Register.