Reed Smith Client Alerts

On July 31, the Food and Drug Administration (FDA) announced its intention to exclude 19 bulk drug substances that were previously nominated by the compounding industry for inclusion on the 503B Bulks List (Bulks List) and have been under review by the agency. While FDA continues to disqualify numerous bulk drug substances from the Bulks List, it also expressed for the first time its aim to approve four bulks drug substances to the Bulks List in this announcement. FDA will accept comments on this announcement until September 29.

FDA’s announcement affects the following bulk drug substances:

To be excluded:

(1) diazepam, (2) dobutamine hydrochloride (HCl), (3)dopamine HCl, (4) edetate calcium disodium, (5) folic acid, (6) glycopyrrolate, (7) hydroxyzine HCl, (8) ketorolac tromethamine, (9) labetalol HCl, (10) mannitol, (11) metoclopramide HCl, (12) moxifloxacin HCl, (13) nalbuphine HCl, (14) polidocanol, (15) potassium acetate, (16) procainamide HCl, (17) sodium nitroprusside, (18) sodium thiosulfate, and (19) verapamil HCl

To be included:

(1) diphenylcyclopropenone (DPCP), (2) glycolic acid, (3) squaric acid dibutyl ester (SADBE), and (4) trichloroacetic acid (TCA)

Under Section 503B of the Food, Drug, and Cosmetic Act, FDA-registered outsourcing facilities may not compound a drug using bulk drug substances unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services identifying bulk drug substances for which there is a “clinical need” (namely, the 503B Bulks List), or (2) the drug compounded from such bulk drug substances appears on the Drug Shortage List.