FDA decisions, compounding rules, import alerts, and the legal landscape that decides what's available, what's banned, and where.
On July 23–24, 2026, the FDA's Pharmacy Compounding Advisory Committee recommended adding six of seven reviewed peptides (BPC-157, KPV, TB-500, MOTS-c, Epitalon, Semax) to the Section 503A Bulks List and rejected Emideltide/DSIP. The vote is advisory only — not a final FDA decision and not legal authorization to compound. FDA must still complete formal notice-and-comment rulemaking (typically 12–24 months) before any change in legal status.
An FDA advisory panel has voted to allow compounding pharmacies to produce copies of certain popular peptide-based weight loss and diabetes drugs, specifically tirzepatide, semaglutide, and retatrutide, during periods of drug shortage. The panel rejected a proposal to allow compounding for a fourth peptide. This decision is a significant victory for the compounding industry and patients seeking lower-cost alternatives, but it raises safety concerns among FDA staff regarding the quality of non-FDA approved versions.
The FDA has issued over 50 warning letters to telehealth companies and medical spas regarding the marketing of compounded GLP-1 obesity drugs. The letters target providers for making false or misleading claims, specifically implying that these compounded versions are identical to FDA-approved branded medications. This action is part of a broader Department of Health and Human Services initiative to regulate direct-to-consumer drug advertising.
The FDA issued a warning letter to ImmunityBio and founder Patrick Soon-Shiong for making false and misleading claims regarding their cancer therapy, Anktiva. The agency criticized the company for suggesting the drug treats 'all cancers' without evidence, failing to disclose required combination use with a vaccine, and downplaying serious risks. The FDA also challenged claims that the treatment renders patients 'cancer free,' stating that such assertions are not supported by clinical data.
An FDA advisory panel has voted to allow the compounding of tirzepatide and semaglutide, major GLP-1 agonists used for weight loss and diabetes, while rejecting a petition for a third peptide. This decision is a significant victory for the compounding industry and patients seeking lower-cost alternatives to branded drugs like Mounjaro and Zepbound, though it bypasses standard safety approvals.
Sanofi has formally requested that the FDA remove its type 1 diabetes drug, teplizumab, from Commissioner Marty Makary's expedited review program. This request follows an unusual intervention by acting CDER director Tracy Beth Høeg, who reportedly overruled career staff scientists regarding the drug's approval. The agency subsequently missed its decision deadline, raising concerns about political interference in the scientific review process.
Across 2025-2026 the FDA's Office of Compliance issued a string of warning letters to internet peptide retailers - including USApeptide.com (February 2025), Gram Peptides (March 2026), and Wholesale Peptide (June 2026) - alleging they are selling unapproved new drugs in violation of Section 505(a) of the FD&C Act. The letters single out products marketed for healing, recovery, and research that the agency says carry disease-treatment claims triggering drug status. Named substances include BPC-157, TB-500 (thymosin beta-4), CJC-1295, ipamorelin, and GHK-Cu. The enforcement runs in tension with the July 2026 PCAC vote recommending several of these same peptides for the 503A compounding list, but legally the two tracks are separate.
On February 21, 2025, the FDA determined that the national shortage of injectable semaglutide (Ozempic/Wegovy) was resolved and removed it from the drug-shortage list, triggering a phased wind-down of pharmacy compounding. State-licensed 503A compounding pharmacies generally lost their shortage-list exception by April 22, 2025, and FDA-registered 503B outsourcing facilities had until May 22, 2025 to cease production. The move mirrors the earlier resolution of the tirzepatide shortage and re-establishes that Novo Nordisk's branded products are the only FDA-approved semaglutide injectables. A pending court challenge left narrow enforcement discretion for some 503A operations, but the policy direction is settled: mass compounding of semaglutide is ending as branded supply catches up with demand.
After a multi-year pharmacovigilance review triggered by a 2024 WHO VigiBase disproportionality signal, the FDA concluded that GLP-1 receptor agonists (semaglutide, tirzepatide, liraglutide, and related drugs) do not increase the risk of suicidal ideation or behavior and formally requested manufacturers remove the related warning labeling. The finding aligns with a parallel European Medicines Agency (EMA) review that likewise found no causal link. Large 2025 cohort studies and meta-analyses published in BMJ and other journals consistently showed no elevated suicide risk versus comparator drugs. The episode illustrates how spontaneous-report databases can flag signals that controlled analyses later rule out.
In December 2024 the FDA approved Eli Lilly's Zepbound (tirzepatide) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity - the first prescription medicine ever cleared for the sleep disorder. The indication was supported by two randomized, placebo-controlled SURMOUNT-OSA trials showing reductions in apnea-hypopnea events and body weight. The approval expands the peptide-based GLP-1/GIP agonist franchise beyond diabetes (Mounjaro) and obesity (Zepbound) into a cardiometabolic comorbidity that affects tens of millions of Americans, and it positions tirzepatide as a disease-modifying therapy rather than a cosmetic weight-loss drug.