If you’re still being told that compounded GLP-1 risks are “overblown,” read the FDA’s latest warning letter.
Last summer, CMPI warned that some large-scale compounders were drifting far from traditional pharmacy practice — importing questionable, if not illegal, foreign ingredients and marketing unapproved GLP-1s at industrial scale.
FDA recently backed up that concern.
It issued a warning letter to Darmerica, LLC — a large API importer supplying compounders — for importing adulterated ingredients from unregistered or FDA-alerted facilities, mislabeling shipments to bypass customs scrutiny, stripping original labels that concealed product origin and grade, and ignoring pharmacy reports of visible contamination in its APIs.
Multiple GLP-1s were involved, including retatrutide and cagrilintide, which are investigational molecules not approved by FDA and indisputably not eligible for lawful compounding.
You can’t build a safe medicine on an illicit or unverified ingredient. When suppliers like Darmerica fail to properly qualify a foreign source, or pass-off illicit API as the real Macoy, they harm both the compounder with whom they transact and the patients who receive the substandard compounded drugs.
This isn’t about legitimate, patient-specific compounding. It’s about commercial scale production without safety standards — and the erosion of guardrails that protect patients. If compounding is to remain a trusted practice, it must stay within clear lines.
Warning letters like this show why stronger oversight is seriously needed. Common sense reforms like those suggested in the SAFE Drugs Act merit immediate attention.
No one should be deceived into believing they’re taking genuine American medicine when they’re really getting an illicit foreign knockoff. Patients deserve medicines made transparently and held to consistent standards.
Anything less is a public health risk.
