Results Wire: US FDA Advisory Committee Reviews Pharmacy Compounding Drug Lists - Drugs Not Allowed and Bulk Substances Allowed – FEB 23-24, 2015 (PCAC)
On Monday-Tuesday, February 23-24, 2015, the Pharmacy Compounding Advisory Committee (PCAC) agreed with the FDA’s proposed revisions to the list of drug products that may not be compounded under exemptions provided by the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Specifically the committee agreed to add the following products to this list: alatrofloxacin mesylate, aminopyrine, astemizole, bromfenac sodium (except ophthalmic solutions), cerivastatin sodium, cisapride, parenteral drug products containing esmolol HCl that supply 250 mg/milliliter (mL) of concentrated esmolol per 10 mL ampule, etrenitate, gatifloxacin (except ophthalmic solutions), grepafloxacin, methoxyflurane, novobiocin sodium, extended-release drug products containing oxycodone hydrochloride that have not been determined by FDA to have abuse-deterrent properties, pemoline, pergolide mesylate, phenylpropanolamine, the combination of PEG 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, and 10 milligrams (mg) or more of bisacodyl delayed-release tablets, propoxyphene, rapacuronium bromide, rofecoxib, sibutramine hydrochloride, tegaserod maleate, troglitazone, trovafloxacin mesylate, and valdecoxib.
The Committee agreed with the FDA proposal for adding four substances that were nominated for inclusion on the bulk substances list: Cantharidin, diphenylcyclopropenone, squaric acid dibutyl ester, and thymol iodide.
The Committee agreed with the FDA proposal for excluding two substances that were nominated: silver protein mild and piracetam.