Anyone have any advice on the fate of formulating with Hydroquinone in regards to the CARES act?
For example, the most recently applicable proposed classification issued for hydroquinone skin bleaching products was the proposal that such products be classified as Category II (i.e., not GRASE) in the TFM issued in 2006; thus, although such products have been marketed for years under the non-final OTC monograph proceedings for OTC skin bleaching drug products, they now must be removed from the market within 180 days of the enactment of the CARES Act (i.e., by September 23, 2020), unless FDA issues an administrative order directing otherwise.
Does this mean professional products use as well? Can you delist the OTC registration and still use HQ?
Thanks in Advance!