Glycolic acid, TCA among FDA's 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 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, acting director of FDA’s Center for Drug Evaluation and Research (CDER). “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.
As part of the rolling review process of which bulk drug substances to include on the 503B bulks list, the agency is weighing safety against the need for access, said Cavazzoni: “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.”
The agency’s Federal Register entry lists the 19 substances not proposed for inclusion: diazepam, dobutamine hydrochloride (HCl), dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate, hydroxyzine HCl, ketorolac tromethamine, labetalol HCl, mannitol, metoclopramide HCl, moxifloxacin HCl, nalbuphine HCl, polidocanol, potassium acetate, procainamide HCl, sodium nitroprusside, sodium thiosulfate, and verapamil HCl.
“For each of these proposals, we are seeking comments from the public before making a final decision. The FDA will continue to evaluate other bulk substances for inclusion on this list as part of our continuing efforts to help ensure availability for patients who require access to medically necessary compounded drug products,” Cavazzoni said.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.