The Food and Drug Administration's April 1 guidance narrowed the 503A and 503B compounding exemptions that had allowed online telehealth companies to sell compounded semaglutide and tirzepatide — the active ingredients in Ozempic, Wegovy, and Mounjaro — at roughly a tenth of the branded price. [1] The paper's April 16 account of the ad flood that preceded the clarification ended with the regulator's enforcement posture described as still undetermined. It is less undetermined now.

Semaglutide and tirzepatide no longer qualify for bulk 503B compounding. [2] Small-batch 503A pharmacies can still compound for individual patients with a documented clinical reason, but the previously common practice of adding vitamin B12 to market the product as "different" from the branded drug is gone. [2] The FDA has already issued more than 55 warning letters to online sellers in the first quarter, many for marketing claims rather than for safety violations. [1]

On April 3, the same agency removed the suicide-ideation warning from the labels of the branded GLP-1 drugs after a systematic review found no causal link in the post-marketing data. [3] The two actions are not inconsistent. They are symmetrical: regulators are simultaneously tightening the compounded market and reassuring patients of the branded one. X frames that symmetry as protecting Novo Nordisk's $1,300-per-month monopoly. The FDA frames it as standard enforcement discretion.

The practical effect for patients is narrower supply, higher prices, and — for anyone still ordering from a 503B pharmacy that has not reclassified — a product now explicitly outside the law.

-- NORA WHITFIELD, Chicago