APC: PCAC recommends three substances for 503A bulks list

June 11, 2021

PCAC recommends three substances for 503A bulks list

FDA’s Pharmacy Compounding Advisory Committee met Wednesday, voting to recommend adding melatonin, methylcobalamin, and oxitriptan to the 503A bulks list.

PCCA’s AJ Day, a member of APC’s Board of Directors, presented on behalf of APC and NCPA in support of recommending including methylcobalamin on the list. (FDA staff had recommended that methylcobalamin not be included, but PCAC members disagreed.)

Among the committee’s actions:

After the meeting, Day sought to manage expectations. “It’s just a committee vote,” he said. “FDA can still decide whatever it wants.” He also emphasized that the items were nominated, evaluated, and discussed for specific uses, but if FDA places them on the 503A bulks list, it will not be for specific uses. FDA may put parameters on the route of administration, but not the use/diagnosis. How quickly FDA will act on the PCAC recommendations is not known.