Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph

摘要

The Food and Drug Administration (FDA) is reopening the administrative record and proposing to amend the tentative final monograph (proposed rule) for over-the-counter (OTC) laxative drug products to reclassify the bulk-forming laxative psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond)), psyllium seed husks, plantago ovata husks, and plantago seed)) in a granular dosage form from Category I (generally recognized as safe and effective and not misbranded) to Category II (not generally recognized as safe and effective or misbranded). The granular dosage form affected by this proposal includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; any granules that are dispersed, suspended, or partially dissolved in liquid prior to swallowing; any granules that are chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; and any granules that are sprinkled over food. FDA is issuing this proposed rulemaking after considering data and information on the safety of some currently marketed products containing psyllium in a granular dosage form. This proposed rulem