FDA recommends 503B bulks list addition; rejects HCQ sulfate

Regulatory NewsRegulatory News
| 24 March 2021 | By Kari Oakes 

The US Food and Drug Administration (FDA) has preliminarily recommended that one additional substance be added to its list of bulk drug substances for outsourcing facilities to use in compounding.
FDA is proposing that quinacrine hydrochloride be added to the list, commonly referred to as the 503B bulks list. This bulk drug substance, while not a component of an FDA-approved drug, is used to compound oral treatments for cutaneous lupus erythematosus. (RELATED: Glycolic acid, TCA among proposed additions to 503B bulk drugs list, Regulatory Focus 30 July 2020)
“Access to compounded medicines is important for patients whose medical needs cannot be met by an FDA-approved drug,” said Donald Ashley, JD, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research (CDER). “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,” added Ashley in the press statement announcing the addition.
FDA also considered four other bulk substances for inclusion in the 503B bulks list. Ultimately, the agency felt that the statutory requirement of clinical need for an outsourcing facility to compound drugs that started from the four bulk substances had not been met.
The four substances considered but not proposed for inclusion are hydroxychloroquine sulfate, bromfenac sodium, nepafenac and mitomycin-C.
The evolution of the 503B bulks list involves striking the balance of assuring sufficient patient protection without compromising access to needed compounded drugs, said Ashley. “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."


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Tags: compounding, FDA, US

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