Compounded GLP‑1s persist

A secret-shopper study found that off-brand compounded weight-loss drugs are still easy to buy, even after federal shortages of the branded versions officially ended. (healio.com) Glucagon-like peptide-1 drugs help control blood sugar and appetite, and brand-name versions such as Wegovy, Ozempic, Zepbound, and Mounjaro drove demand high enough to trigger shortages beginning in 2022. Researchers said that shortage helped create a fast-growing market for compounded semaglutide and tirzepatide sold through clinics and medical spas. (healio.com) In the new study, University of Colorado researchers called 78 responding businesses in two states from August through October 2025 while posing as customers. They found 69 of 74 businesses offered compounded semaglutide and 65 of 74 offered compounded tirzepatide. (healio.com; ispor.org) The same researchers identified 22 supplying facilities. Two were neither licensed as traditional section 503A compounders nor registered as section 503B outsourcing facilities, and three section 503A facilities lacked an active sterile compounding license. (ispor.org) Three facilities had received a Form FDA 483 inspection notice since 2023 for objectionable sterile compounding practices, one had received an FDA warning letter, and two had faced state disciplinary action since 2023. Those records were matched using public licensing and regulatory databases, the researchers said. (ispor.org) Federal policy had already shifted. The Food and Drug Administration said tirzepatide shortage conditions were resolved in December 2024 and said semaglutide shortage conditions were resolved on February 21, 2025. (fda.gov; content.govdelivery.com) After court fights over compounding, the Food and Drug Administration said its enforcement discretion for state-licensed semaglutide compounders ended on April 22, 2025, and for section 503B outsourcing facilities on May 22, 2025. For tirzepatide, the comparable grace periods had already ended in March 2025. (fda.gov) Researchers said about 60% of businesses in their sample were selling formulations with added ingredients such as glycine, levocarnitine, or B vitamins. They said that pattern was consistent with a move toward claiming the products were patient-specific rather than direct copies of commercially available drugs. (healio.com) The Food and Drug Administration says compounded drugs are not reviewed in advance for safety, effectiveness, or quality, and says they should be used only when a patient’s medical need cannot be met by an approved drug. The agency has also warned that some compounded injectable products arrived warm or with inadequate ice packs, which can affect quality. (fda.gov) On April 1, 2026, the Food and Drug Administration reminded compounders that section 503A products must be made for an individual patient based on a prescription and must not be compounded regularly or in inordinate amounts if they are essentially copies of commercially available drugs. (fda.gov) Drugmakers and obesity groups have kept pressing the issue. Novo Nordisk says unauthorized compounded semaglutide threatens patient safety, and Eli Lilly warned on March 12, 2026 that tirzepatide mixed with vitamin B12 may contain an impurity of unknown effects; The Obesity Society issued a statement the same day citing reports of impurities in compounded tirzepatide plus vitamin B12. (novonordisk.com; pharmacy.ky.gov; obesity.org) The study was presented this week at the Obesity Medicine Association meeting in San Diego, and it points to a market that outlasted the shortages that helped create it. The next fight is likely to stay with regulators, state pharmacy boards, and courts rather than with supply alone. (healio.com; fda.gov)