On April 1, the Food and Drug Administration issued a statement reminding 503A compounding pharmacies and 503B outsourcing facilities that semaglutide and tirzepatide — the active ingredients in Ozempic, Wegovy, Mounjaro and Zepbound — no longer appear on the agency's drug-shortage list. [1] The statutory exemption that had allowed American compounders to mass-produce copies of the drugs through the shortage years has ended. The FDA also offered an illustrative example: a compounded product combining semaglutide with vitamin B-12 is still a copy, the agency said, when the other ingredient is unlikely to make a clinical difference for the patient. [2]

Three weeks out, the market has taken the hint and built the workaround. The FDA's limited-enforcement policy for 503A pharmacies covers four or fewer prescriptions per pharmacist per day — a historical safe harbor. Within those numbers, compounded semaglutide-plus-B12 and tirzepatide-plus-B12 formulations are now the default online product at firms below the Hims and Hers tier, which reached a separate commercial detente with Novo Nordisk in March. [3] The 30 warning letters the FDA sent to telehealth companies on March 3 have not all publicly resolved. Some companies have stopped advertising semaglutide by name while continuing to ship it.

The retail consequence the science press did not foreground: prices on the compounded market have doubled or tripled from the winter lows. Patient communities report monthly compound costs at $350 to $600, against branded cash prices of $1,000 to $1,350. [2] That gap keeps the compounded market alive and explains why the B-12 workaround took. Whether the FDA's next move is a bulks-list action against semaglutide as an API — the step that would actually end the compounded market — is the question the next three weeks will answer. The anniversary of the clarification is Tuesday.

-- NORA WHITFIELD, Chicago