Import alert and Empower
Weekly Research Update · September 28, 2026
INDUSTRY UPDATE
September 21–28 turned on the border and the compounding counter. FDA revised its GLP-1 import alert and issued a warning letter to Empower Pharmacy. No new peer-reviewed work on the peptides we track made the cut.
Must-know
1) FDA revises Import Alert 66-80 (Sep 21) — FDA published a major revision of the detention-without-physical-examination alert covering GLP-1 receptor agonist bulk drug substances. The Green List section now gives examples of the documents a firm must file to be added. Orforglipron API and an intermediate were listed for certain manufacturers, and the alert adds new product codes, including one for Hormone N.E.C. FDA also restated what it found at 48 GLP-1 API sites: 21 percent failed section 501 of the Food, Drug, and Cosmetic Act, registrations were often short-lived, and many firms did not answer records requests. Companies on the Green List that meet the higher documentation bar stay off automatic detention. Other foreign GLP-1 active ingredients can be held at the border. That reaches 503A and 503B compounders and research-use vendors working with semaglutide- and tirzepatide-related substances. A research-use line on the label does not settle the question. FDA still decides intended use from the record, including marketing and reconstitution aids.
2) Warning letter to Empower Pharmacy (dated Sep 18; public Sep 22–25) — Warning letter MARCS-CMS 738238 cites Empower Clinic Services LLC, doing business as Empower Pharmacy, for compounded tirzepatide with niacinamide and semaglutide with cyanocobalamin. FDA says the products “appear to be essentially copies” of approved drugs even with the vitamins added, and treats the pharmacy’s production volume as evidence that those differences are a pretext. The letter also cites insanitary conditions and CGMP failures from a November 2025 inspection, plus prescriber determinations that read as copied from file to file. Adding a B vitamin, or offering a different strength, did not take these products outside that theory. Volume and the prescribing record are part of the review. The same intended-use test applies to research-use products, and this letter shows how scale and presentation can undo a 503A exemption.
ALSO ON THE RADAR
State attorneys general · peptide trials
On September 25, coverage described a bipartisan letter from about 20 state attorneys general, sent around September 17. The attorneys general named Chinese GLP-1 API suppliers with alleged ties to fentanyl production and criticized the Green List pathway. Coverage connects that letter to the September 21 revision of Import Alert 66-80. Foreign peptide supply chains are drawing more attention from state officials and at the border, which adds pressure on compounding and research sourcing.
No new peer-reviewed study, preprint, or ClinicalTrials.gov update on BPC-157, TB-500, GHK-Cu, MOTS-c, SS-31, the CJC-1295 and ipamorelin family, or retatrutide met this week’s freshness and quality bar. Registered BPC-157 trials NCT07437547 and NCT07803250 showed no material status change in the window.
Set aside this week: the July 2026 Pharmacy Compounding Advisory Committee peptide votes, the August 24 research-seller warning letters that posted in early September, the May 2026 proposal to exclude semaglutide, tirzepatide, and liraglutide from 503B compounding, and older product-specific guidances for generic peptides. Those items sit outside this seven-day window or repeat earlier reporting.
Window: Sep 21–28, 2026. Also checked: FDA.gov, ClinicalTrials.gov, PubMed, the Federal Register, Endpoints News, Fierce Pharma, STAT, BioPharma Dive, Pharmacy Times, and Drug Topics.
RECENT RESEARCH & SCIENCE LINKS
FDA Import Alert 66-80 (revised Sep 21, 2026) — GLP-1 bulk drug substances
https://www.accessdata.fda.gov/CMS_IA/importalert_1186.html
FDA Warning Letter MARCS-CMS 738238 (Sep 18, 2026) — Empower Pharmacy
ClinicalTrials.gov NCT07803250 — no material status change (also checked NCT07437547)
https://clinicaltrials.gov/study/NCT07803250
All products are intended strictly for research use only — not for human consumption, diagnostic, or therapeutic purposes.