Empower Pharmacy (Empower Clinic Services, LLC) is a Houston-based compounding pharmacy that makes patient-specific drugs under section 503A of the Federal Food, Drug, and Cosmetic Act, including compounded semaglutide and tirzepatide.
In a warning letter dated September 18, 2026, following a November 3-14, 2025 inspection, the FDA said Empower's semaglutide and tirzepatide products appear to be 'essentially copies' of FDA-approved drugs and did not meet the conditions of section 503A. The agency pointed to prescriber determinations of a 'significant difference' that appeared verbatim across many records, suggesting they may be pre-generated, and to the volume of orders for formulations such as tirzepatide with niacinamide, with the counts redacted in the public letter. It also cited insanitary conditions, including inadequate airflow smoke studies in the ISO 5 area and media fills not run under the most challenging conditions. Empower was given 15 working days to respond.
Stories here cover FDA enforcement against Empower and the wider fight over compounded GLP-1s. See #compounding, #503a, #semaglutide, and #tirzepatide.
The FDA issued a warning letter dated September 18, 2026 to Houston-based Empower Pharmacy after a November 3-14, 2025 inspection, saying its compounded semaglutide and tirzepatide products appear to be 'essentially copies' of FDA-approved drugs and did not meet the conditions of section 503A. The agency said prescriber determinations of a 'significant difference' appeared to be repeated verbatim across many records, suggesting they may be pre-generated, and called the differences between Empower's products and the approved drugs 'pretextual.' The letter also cites insanitary conditions, including inadequate smoke studies of airflow in the ISO 5 area and media fills not run under the most challenging conditions. Empower has 15 working days to respond; BioSpace reported the letter on September 24.
The post-PCAC telehealth peptide competitive landscape continues to shape investor attention. Hims & Hers Health (NYSE: HIMS) Q2 2026 revenue of $753.2 million (+38% YoY) reported Monday August 10 after market close positions Hims as the largest US telehealth peptide-strategy sponsor. LifeMD (NASDAQ: LFMD) has approximately 310,000 active telehealth subscribers per recent investor materials, with 2025 revenue guided at $265-275 million. Ro and Henry Meds round out the large-player telehealth set. Key institutional commenters supporting the July 23-24, 2026 FDA Pharmacy Compounding Advisory Committee (PCAC) 6-of-7 vote recommendation included the Alliance for Pharmacy Compounding, Empower Pharmacy, American Institute for Compounded Therapeutics, Texas Pharmacy Association, real-world data platform Peptide AI, and the American Academy of Peptide Medicine. The July 23-24 vote recommendation (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon approved 6 of 7; Emideltide/DSIP rejected) sets up the prospective legal compounding channel once FDA rulemaking completes (typically 12-24 months per PCAC-recommended substance). Enforcement context: the FDA issued 40+ warning letters and 100+ cease-and-desist notices to compounders and telehealth companies in 2024-2025 (the single largest enforcement action in compounding-pharmacy regulation history), and by March 2026 the FDA had sent warning letters to 30 additional telehealth companies with total enforcement actions exceeding 125 warning and untitled letters. The February 2027 PCAC second-peptide meeting (LL-37, GHK-Cu, dihexa acetate, melanotan II, PEG-MGF) will further shape the compounding landscape.
Empower Pharmacy published a detailed industry analysis of the FDA's April 16 announcement removing 12 peptides from Category 2 and convening the July 23-24 PCAC meeting. The piece walks through the practical implications for compounding pharmacies, distinguishes Category 2 removal from Section 503A Bulk Drug Substances List inclusion, and emphasizes the gap between regulatory action and clinical access — physicians and patients are pressuring compounders to prepare peptides legally restricted only weeks ago.