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

Краткое содержание

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.