USA – Glycolic acid, TCA among proposed additions to 503B bulk drugs list

Four new bulk substances are up for inclusion on the list of active pharmaceutical ingredients that outsourcing facilities can use in drug compounding under section 503B of the Federal Food, Drug, and Cosmetic Act, according to a proposal from the US Food and Drug Administration (FDA).
The four substances FDA is proposing to include as bulk drug substances are diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester and trichloroacetic acid. An additional 19 bulk drug substances were considered for inclusion in the 503B bulk drug substances list, but FDA is proposing not to include these substances, citing a lack of clinical need for an outsourcing facility to compound drugs from the 19 substances. This lack of need, said the agency, meant the drugs did not meet the statutory criteria for addition to the list.
“If the proposal is finalized, outsourcing facilities would be authorized to use these substances in compounding as long as they meet the other conditions in section 503B,” said Patrizia Cavazzoni, MD, Acting Director of FDA’s Center for Drug Evaluation and Research (FDA). “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,” she said…