FDA Issues Proposed New Rule Regarding Hydroquinone
As part of the Food and Drug Administration’s (FDA’s) ongoing review of over-the-counter drug products, it has issued a notice of proposed rulemaking regarding hydroquinone.
New data from laboratory research have shown some evidence of carcinogenicity although such carcinogenicity has not been shown or established in humans. The data also show potential for discoloration and disfigurement when topically applied on humans. Due to this concern, the FDA is proposing that skin bleaching products should not be available over the counter. It finds that hydroquinone should be restricted to prescription use only, with users closely monitored under medical supervision.
Comments on the proposed rule are due to the FDA by December 27, 2006. The final ruling by the FDA will occur 30 days after it reviews all comments and reaches a decision.
The Doctors Company’s Department of Patient Safety recommends the following actions for physicians or health care providers who provide or dispense skin care products containing hydroquinone:
- Review all skin care products sold or provided to patients to determine if they contain hydroquinone.
- Discontinue selling the product over the counter.
- Dispense by prescription only.
- Evaluate each patient prior to prescribing.
- Provide appropriate medical supervision
of patient use. - Inform the patient of the information described in the FDA notice, and document the discussion in the medical record.
A complete text of the FDA proposed rulemaking
can be found in the Federal Register at www.fda.gov/ohrms/dockets/98fr/E6-14263.pdf.
J6690 11/06
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.