FDA Adds Four New Drugs to 503B Bulks List, Says No to Another Eight

The FDA has added four new drugs to its list of bulk drug substances, also referred to as active pharmaceutical ingredients, for which there is a clinical need. This is known as the 503B Bulks List.

The four new drugs are: diphenylcyclopropenone (DPCP) for topical use only; glycolic acid for topical use only in concentrations up to 70 percent; squaric acid dibutyl ester for topical use only; and trichloroacetic acid for topical use only.

The FDA also noted that there were eight bulk drug substances that it considered but is not including on the list at this time. Those are: diazepam; dipyridamole; dobutamine hydrochloride (HCl); dopamine HCl; edetate calcium disodium; folic acid; glycopyrrolate; and sodium thiosulfate (except for topical administration).

Read the notice here: www.fdanews.com/01-26-22-notice2.pdf.