Big Buttons

• FDA doubles down: Tirzepatide is off shortage

  ...but that doesn't mean the issue is completely settled. read more →

• A couple of state updates

  Good news from Alabama, but a problem in Massachusetts read more →

• Defending GLP-1 compounding

  The latest letters APC's been sending to oppose efforts to restrict compounding read more →

• Thumbs-up for FDA crackdown

  APC was thrilled when the FDA announced it was taking action against illegal online businesses claiming to sell “research-grade” compounds. read more →

• A PANS/PANDAS explainer

  For your patients: Information about a couple of underdiagnosed pediatric mental health conditions read more →

• What, a year?

  In the final board chair column of the year, here are our top 7 accomplishments in 2024. read more →

• “Simply not a rational approach to regulating an industry”

  This week APC offered its final (and pointed) suggestions to the California Board of Pharmacy on their proposed significant – and we would say unjustified – changes to their compounding regulations. read more →

• Get a cease and desist letter from Verrica?

  APC has heard reports from several pharmacies that have received them — here's what to know. read more →

More News

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.