An FDA advisory committee could soon decide the fate of compounded B12 shots. Action Alert!

One June 9th, 2021, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) will meet to discuss whether traditional compounding pharmacies will be permitted to make medicines with methylcobalamin, choline chloride, and melatonin, among others. That compounded methylcobalamin, a bioavailable form of vitamin B12, is on the chopping block is particularly concerning, as it has shown promise in the treatment of autism and other health problems. We must speak out so the FDA knows that consumers rely on these vital medicines.

As a reminder, PCAC advises the FDA in writing new rules regarding what supplements and drugs can be made individually for patients with specific needs by compounding pharmacies. PCAC has met a handful of times over the last few years, and as we’ve noted elsewhere, the track record is not good. The committee has voted to ban almost every compounded natural treatment put before it, including curcumin, boswellia, and aloe vera—usually following the FDA’s recommendation. PCAC meetings are one step in the FDA’s process; to ban an ingredient from compounding requires publishing a proposed rulemaking, which the public can comment on and voice concerns about.