Drug Labeling; Warning and Direction Statements for Rectal Sodium Phosphates for Over-the-Counter Laxative Use; Final Rule; Stay of Compliance

The Food and Drug Administration (FDA) is staying compliance for the regulation for warning and direction statements for over-the- counter (OTC) dibasic sodium phosphate/monobasic sodium phosphate (sodium phosphates) drug products intended for rectal (enema) use until December 7, 1998. The regulation established conditions under which the labeling must include warning and direction statements for oral and rectal sodium phosphates products. This stay of compliance applies only to rectal sodium phosphates products and is in response to requests and a citizen petition that the final rule did not allow sufficient time for relabeling of these products. This final rule is part of the ongoing review of OTC drug products conducted by FDA.