FDA won’t classify bowel products as Rx only

FDA won’t classify bowel products as Rx only

Dickinson, James G

The FDA denied a Braintree Laboratories petition that asked it to reclassify OTC sodium phosphate bowel preparations as prescription-only products. The petition, submitted a year ago, also sought a boxed warning on product labeling to caution against use if patients have electrolyte, renal, or cardiovascular abnormalities. The FDA did say it was concerned with adverse events that have occurred and will propose new regulations to limit the container size to not more than 45 ml and add a warning statement on OTC labels advising of the potential for adverse events and contraindications for use.

Copyright CPS Communications Sep 2001

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