Antidiarrheal Drug Products for Over-the-Counter Human Use—Final Rule

The FDA issued a final rule in the form of a monograph that establishes conditions under which over-the-counter (OTC) antidiarrheal drug products (to control the symptoms of diarrhea) are generally recognized as safe and effective and not misbranded. This final rule is part of the FDA's ongoing review of OTC drug products. Also, this final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC antidiarrheal active ingredients that have been found to be not generally recognized as safe and effective. This rule is effective April 19, 2004. The compliance date for products with annual sales less than $25,000 is April 18, 2005. The compliance date for all other OTC antidiarrheal drug products is April 19, 2004. Food and Drug Administration, HHS Fed Regist 2003 Apr 17;68(74):18869-82 More information can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/03-9381.htm. Return to Top