FDA’s Pharmacy Compounding Advisory Committee this week voted to recommend that FDA add glutathione to the final 503A Bulks List, signaling that it can be compounded. The 8-5 vote, with one abstention, is not binding on FDA, however.
“As with methylcobalamin last year, the committee bucked the FDA staff’s recommendation against adding glutathione to the bulks list,” said APC’s Scott Brunner. “And just as with methylcobalamin, now we wait to see what formal action FDA may take on PCAC’s recommendation.”
Representing PCCA and NCPA, APC board member and PCCA Vice President of Clinical Services A.J. Day made a case to the committee for why the substance should be added to the bulks list.
“A.J. did a heroic job dismantling FDA’s inaccurate assessments of research that the agency referenced to argue against the addition of glutathione,” said Brunner, “And he did it under duress. While the FDA had a fairly unlimited time to present to the committee, A.J.’s presentation was limited, and he was cut off before completion.
He was forced to speak incredibly rapidly, yet still made a thorough case for why FDA was off base in its recommendation.”
“This is a win, thanks to A.J., and we’ll take it,” added Brunner. “But we simply must protest this PCAC process, from the insufficient time to review materials prior to the meeting to the limit of a 10-minute presentation per substance to the lack of any deliberation at all among committee members. We will raise it at next week’s compounding listening session with FDA for sure.”
In addition to glutathione, PCAC considered three additional substances for the 503A Bulks List in its meeting this week. The other three are ferric subsulfate, enclomiphene citrate, and ammonium tetrathiomolybdate. Only glutathione received the committee’s recommendation. PCAC also voted to add lorcaserin hydrochloride to the Withdrawn or Removed List, which affects 503A and 503B compounders.