PCAC recommends three substances for 503A bulks list

Published June 11, 2021

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:

  • Melatonin, typically used for treatment of sleep disorders in patients with autism spectrum disorder (specifically children and adolescents), was recommended on a vote of 13-0.
  • Methylcobalamin — notably a treatment for amyotrophic lateral sclerosis, pain management (peripheral neuropathy, including diabetic neuropathy), inborn errors of metabolism, hyperhomocysteinemia, vitamin B12 deficiency, and autism — was recommended by a vote of 9-5.
  • Oxitriptan, also known as 5-hydroxytryptophan or 5-HTP and often used for treatment for patients with tetrahydrobiopterin deficiency, was recommended by a vote of 11-0-1.
  • Finally, choline chloride, commonly used for treatment of liver diseases, atherosclerosis, fetal alcohol spectrum disorder, and supplementation in long term total parenteral nutrition, was not recommended by a vote of 2-11-1.

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.