Zdrowie i gospodarka · 11/02/2011

FDA Proposes Rule to Amend Laxative Drug Product Monograph

The FDA is proposing a rule to amend the tentative final monograph for over-the-counter laxative products, removing sodium phosphate salts from the list of generally recognized as safe for bowel cleansing due to serious side effects associated with their use. The proposed rule would also withdraw professional labeling for sodium phosphate salts, which is intended for healthcare professionals.