51 stories
Compounding is where the GLP-1 supply economy actually lives. The FDA's 2022–2024 shortage designations created a window for 503A patient-specific compounders and 503B outsourcing facilities to produce semaglutide and tirzepatide at a fraction of branded prices. Telehealth platforms — Hims & Hers, Ro, LifeMD, Eucalyptus — built distribution on top of that channel.
The window closed once the agency declared the shortages resolved. Since then, the rules have been rewritten in pieces: Category 2 placement for BPC-157 and other research peptides; the April 30, 2026 FDA proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list; the Outsourcing Facilities Association lawsuit; and a University of Colorado secret-shopper study finding 65–69 of 74 medspas still sold compounded GLP-1s in April 2026. The Partnership for Safe Medicines applauded the 503B proposal and plans to file a Federal Register comment ahead of the June 29 deadline; Orrick's May client memo told outsourcing facilities, weight-loss clinics, and telehealth platforms still leaning on compounded supply to consult counsel.
Stories here cover both the legal and economic dimensions. See #503a, #503b, #category-2, and #fda for adjacent threads.
A Utah physician was indicted for importing and selling misbranded drugs from China to over 200 patients. Customs separately seized 5,000 unapproved peptide units at the border.
The FDA published warning letters targeting companies marketing GLP-1 receptor agonists without regulatory approval, addressing CGMP violations and clinical trial protocol failures.
The FDA announced steps to restrict compounded GLP-1 products, specifically naming Hims & Hers. Novo Nordisk has also sued Hims & Hers over compounded semaglutide.
Hims & Hers Health stock rose on reports the FDA is preparing to allow compounding pharmacies to produce previously banned injectable peptides, potentially expanding the telehealth company's operations.
Federal regulators are moving toward restoring legal access to injectable peptides barred from pharmacy compounding in 2023, which could redirect patients from unregulated online sellers to regulated pharmacy channels.
STAT's pharmaceutical roundup covers the FDA's expected move to allow compounding of previously banned peptides and the impact of the Iran conflict on global clinical trial recruitment.
The FDA is moving to allow compounding pharmacies to produce 14+ injectable peptides banned in 2023. Health Secretary RFK Jr. publicly backed the reversal, while top FDA leaders reportedly have reservations about politically-driven decisions.
The FDA issued warning letters to 30 telehealth firms for false or misleading claims about compounded GLP-1 weight-loss products, signaling a major crackdown on illegal online marketing.
Longevity enthusiasts anticipate FDA loosening restrictions on BPC-157, ipamorelin, and MOTs-C. Industry notes it may take months for compounding pharmacies to ramp up supply after reclassification.
Eric Topol of Scripps Research called peptide data "woefully minuscule," warning about impurities, random dosing, and dangerous stacking of unproven compounds from gray-market sources.
In-depth AP investigation on influencers and celebrities promoting unapproved injectable peptides produced by compounding pharmacies without FDA-level scrutiny.
Analyzes the announcement that ~14 of 19 peptides on FDA's Category 2 list will move back to Category 1, restoring access through licensed compounding pharmacies with a prescription.
APC CEO Scott Brunner discusses the regulatory landscape for compounded GLP-1 receptor agonists amid increasing scrutiny and legal battles over compounded peptide drugs.
Companies are rushing to upgrade from gray-market research-grade to medical-grade peptide standards to supply doctors' offices as deregulation approaches.
Healthcare Brew reports that despite the FDA sending thousands of warning letters since September 2025, compounded semaglutide and tirzepatide prescriptions have increased since the semaglutide shortage ended in February 2025. About 80% of compounded GLP-1 prescriptions now include supplemental ingredients like B vitamins to avoid being classified as exact copies of FDA-approved drugs.