Drug Products For Over-the-Counter Human Use; Proposed Rule
The Food and Drug Administration (FDA) is issuing a notice
proposed rulemaking that would establish that over-the-counter
(OTC) skin bleaching drug products are not generally recognized
as safe and effective (GRASE) and are misbranded. FDA is also
withdrawing the previous proposed rule on skin bleaching drug
products for OTC human use, which was issued in the form of
a tentative final monograph (TFM).
FDA is issuing this proposed rule after considering new data
and information on the safety of hydroquinone, the only active
ingredient that had been proposed for inclusion in a monograph
for these products.
This proposal is part of FDA's ongoing review of OTC drug
Further, upon issuance of a final rule, FDA intends to consider
all skin bleaching drug products, whether currently marketed
on a prescription or OTC basis, to be new drugs requiring
an approved new drug application (NDA) for continued marketing.