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.