PCAC votes against four nominated bulk drug substances

FDA’s Pharmacy Compounding Advisory Committee voted at a meeting Tuesday against adding four substances to the 503A bulks list of substances that can be used for compounding: L-theanine, ibutamoren mesylate, ipamorelin, and kisspeptin-10. The committee also voted unanimously to add hydroxyprogesterone caproate to the FDA list of withdrawn drugs that should not be compounded. The next PCAC meeting is scheduled for Dec. 4.