FDA recommends 503B bulks list addition; rejects HCQ sulfate

FDA is proposing the addition of quinacrine hydrochloride to its list of bulk drug substances for use in compounding by outsourcing facilities, commonly referred to as the 503B bulks list. Quinacrine hydrochloride is not a component of an FDA-approved drug but is used to compound oral treatments for cutaneous lupus erythematosus. Donald Ashley, JD, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, said: “Access to compounded medicines is important for patients whose medical needs cannot be met by an FDA-approved drug. While compounded drugs do not undergo premarket review for safety, effectiveness, and quality, we recognize they can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug.” FDA also considered four other drug substances for inclusion in the 503B bulks list, but determined they did not meet the statutory requirement of clinical need: hydroxychloroquine sulfate, bromfenac sodium, nepafenac, and mitomycin-C. Ashley said, “We’ll continue to evaluate other bulk substances for inclusion on this list as part of our continuing efforts to help ensure compounded drugs are available for patients who need them.”