The U.S. Food and Drug Administration (FDA) proposed to include four bulk drug substances on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug & Cosmetic Act. The four bulk drug substances are: diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester and trichloroacetic acid. These substances are not components of FDA-approved drug products.
The FDA also identified 19 bulk drug substances that the agency has considered and proposed not to include on the 503B bulks list. Based on the information reviewed, the agency did not find a clinical need for an outsourcing facility to compound drug products starting from these bulk drug substances, and therefore the statutory standard for adding these bulk drug substances to the 503B bulks list has not been met. The FDA is seeking public comment on this proposal before finalizing its decision.
“As part of our oversight efforts to help ensure that Americans have access to compounded medicines, we are developing and evaluating a list of bulk drug substances that outsourcing facilities can use in compounding when it’s been determined that there is a clinical need. We believe that patients should have access to these drugs when their medical needs cannot be met by an FDA-approved drug,” Patrizia Cavazzoni, M.D., Acting Director of the FDA’s Center for Drug Evaluation and Research said. “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 product. As we develop the 503B bulks list, we are balancing these goals of patient protection and access to compounded drugs for patients who need them, particularly compounded drugs intended for use in health care systems, including use for office stock.”