Where is the Hydroquinone? Regulatory Change Hinders Access

Changes to FDA regulations implemented as part of the CARES Act this spring have left dermatologists and their patients scrambling to access hydroquinone. Although access is hindered, it is not cut off.

“I think most people at this point are familiar with the CARES Act. What they may not realize is that it contained provisions that fundamentally changed the way the FDA will now review and approve over-the-counter drugs, including hydroquinone, to be available in the market to consumers,” observes Ondrej Staviscak Diaz, General Counsel* at Sincerus Pharmaceuticals, an FDA-Registered 503B Outsourcing Facility. “Without getting into the nitty gritty of how it operates, in practical terms, what the CARES Act has done is to now make it illegal to market over the counter hydroquinone products.

“The CARES Act also had an indirect effect on prescription hydroquinone, because it finalizes what's known as a proposed rule issued by the FDA that had been out for public comment for many years now. That proposed rule at the time stated that not only would hydroquinone products that are available over-the-counter no longer be allowed to be marketed, but also all prescription hydroquinone products would have to be approved by the FDA, either through a new drug application for branded drugs or an abbreviated new drug application for generic drugs.”

Prescription drugs containing hydroquinone that do not go through the NDA or aNDA process are considered misbranded. TriLuma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma)—the only prescription hydroquinone-containing formulation to have come to market under an NDA—remains available on the market.

“Not only patients, but many of my physician colleagues are not aware,” cautions Alia Sampson Brown, MD, Co-managing Partner at Georgia Dermatology Partners. “The CARES Act was such a huge piece of legislation, but this fell through the cracks of public awareness…I am definitely spreading the word to my colleagues and patients about it. Speaking to physicians, some of them are unaware of these legislative changes.”

Prescribers have an avenue for obtaining hydroquinone for their patients, Dr. Brown says. “Importantly, the only sources of compounded hydroquinone products for in-office administration or dispensing without patient-specific prescription are FDA Registered 503B Outsourcing Facilities.”

Dr. Spencer Malkin, Founder and CEO Sincerus Pharmaceuticals, says the regulatory change has brought important attention to the safety of hydroquinone, and “the fact that prescription strength hydroquinone should only be accessed as an FDA approved medicine or as a compounded medicine.” He adds, “I am concerned about reports of prescribers being told by some manufacturers that nothing has changed as they sell prescription strength hydroquinone as an OTC product. This is irresponsible and creates undue risk for prescribers.” 

Dr. Brown emphasizes that prescribers must assess their options. “The key is to work with an FDA-Registered 503B Outsourcing Facility, who are the only legitimate source of hydroquinone compounded products for in-office dispensing,” she says. She works with Prescriber’s Choice (a division of Sincerus), and says, “in-office dispensing has definitely streamlined the prescription process by eliminating medication ‘sticker shock,’ providing convenience, and a wide variety to both insured and cash paying patients. First-time patients don't expect to walk out the office with their prescription ready, but when they do, they tend to be delighted!”

*Not intended as legal advice. Seek legal counsel.