21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

The Food and Drug Administration (FDA) is issuing a proposed rule to reclassify benzocaine from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status. Although, in the Federal Register of February 26, 1982, an advanced notice of proposed rulemaking (ANPR) included the recommendation of an Advisory Panel, consisting of health care providers from outside FDA, recommended that benzocaine should be generally recognized as safe and effective (GRASE) for weight control, this document includes our first evaluation of benzocaine for this use. Based on our evaluation of the available data and information, we have tentatively concluded that the data are not sufficient to support the safety and effectiveness of benzocaine for this use. This proposed rule, if finalized, would require an approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine.

The Food and Drug Administration (FDA) is issuing a proposed rulemaking to amend the tentative final monograph (1985 TFM) for over-the-counter (OTC) laxative drug products (products that relieve occasional constipation). FDA is proposing that sodium phosphate salts (dibasic sodium phosphate, monobasic sodium phosphate, and the combination of dibasic sodium phosphate/monobasic sodium phosphate salts in a solution dosage form) are not generally recognized as safe (GRAS) for bowel cleansing. This document also would withdraw the professional labeling proposed for sodium phosphate salts in the 1985 TFM. Professional labeling is additional information about an OTC drug that is directed to healthcare professionals who prescribe, administer, or dispense medications and is not included in OTC drug product labeling for consumers. FDA is issuing this proposed rule after a careful review of new data and information on the serious side effects that have been associated with the customary dose of OTC sodium phosphates solution (approximately 60 grams (g) of sodium phosphates taken in two 45-milliliter (mL) doses 12 hours apart or approximately 50 g of sodium phosphates taken in a 45-mL dose followed by a 30-mL dose 12 hours later) for bowel cleansing prior to colonoscopy. This proposed rule is part of FDA's ongoing review of OTC drug products.