FDA tightens GLP‑1 oversight

These drugs work by copying gut hormones that tell your brain you’ve eaten and tell your stomach to empty more slowly, so people feel full sooner and stay full longer. Semaglutide is sold as Ozempic and Wegovy, and tirzepatide is sold as Mounjaro and Zepbound. (fda.gov) For two years, shortages turned compounding into a giant side market. Compounding is when a pharmacy mixes a drug for a specific patient, like a tailor altering one suit instead of a factory making 100,000 identical jackets. (fda.gov) The Food and Drug Administration is now trying to shut the door that shortages opened. On February 6, 2026, the agency said it would restrict active ingredients meant for non-approved compounded glucagon-like peptide-1 products that are being mass-marketed as alternatives to approved drugs. (fda.gov) The timing changed because the shortage picture changed. The Food and Drug Administration said tirzepatide injection shortages were resolved in December 2024 and semaglutide injection shortages were resolved in February 2025, then it let some compounders keep operating through wind-down dates in March, April, and May 2025. (fda.gov) The new fight is partly about what goes into the syringe. On April 1, 2026, the Food and Drug Administration said a compounded semaglutide product mixed with another ingredient such as vitamin B12 can still count as an “essentially a copy” if the strength and route are close to the approved drug. (fda.gov) That matters because some sellers used add-ons to make a copy look “custom.” The agency also reminded traditional compounders that they generally need an individual prescription for an individual patient, not a mass-market pipeline. (fda.gov) The other front is advertising. On March 3, 2026, the Food and Drug Administration said it sent 30 warning letters to telehealth companies over false or misleading claims about compounded glucagon-like peptide-1 products on their websites. (fda.gov) The agency says compounded drugs cannot be marketed as generic versions, cannot be described as the same as approved drugs, and cannot be sold with claims that they are clinically proven for a patient when the Food and Drug Administration has not reviewed them for safety, effectiveness, or quality. (fda.gov) One February 20, 2026 warning letter to Lean Rx, which does business as SkinnyRx, quoted website claims such as “Get access to the same active ingredient as name-brand GLP-1 medications” and said those claims were false or misleading. The letter also said SkinnyRx branding on labels could wrongly suggest the company itself compounded the drug. (fda.gov) For patients, the practical split is simple. A compounded drug can still have a legitimate niche when a doctor documents a specific medical need, but the Food and Drug Administration says mass-marketed copies are different from that one-patient exception. (fda.gov; fda.gov) Even with approved products, side effects still need watching. The current Zepbound label lists fatigue among the most common adverse reactions reported in at least 5% of treated patients, alongside nausea, diarrhea, vomiting, constipation, abdominal pain, and indigestion. (accessdata.fda.gov) The Food and Drug Administration also says injectable compounded glucagon-like peptide-1 drugs should arrive cold, because some patients reported shipments that showed up warm or with inadequate ice packs. If a shipment arrives warm, the agency says patients should not use it and should talk to a doctor or pharmacist. (fda.gov)