Finding · criterion S3

Where does the material come from, and what does FDA's GLP-1 import alert say?

None of the 201 sellers read names the country or the facility where its active ingredient is made. 55 print a US-made or compounded-in-the-USA line, which says where the product was finished, and 14 cite an FDA-registered facility or supplier without naming it. FDA's import alert on GLP-1 ingredients lists 21 green-list entries, all outside the United States, 12 of them in China.

• 201sellers read for an origin statement
• 55print a US-made or US-compounded line
• 14cite an FDA-registered source, unnamed
• 135say nothing about origin

The census

42 telehealth services and 13 research vendors print a US line. On a telehealth site it reads, almost word for word, compounded in the USA: a statement about the pharmacy that mixed the vial. On a research vendor's site it more often reads made or manufactured in the USA, a claim about synthesis that no document on the page supports or refutes.

Import Alert 66-80 and the green list

FDA first issued the alert on September 5, 2025, and the current version was published on September 21, 2026. Its title is Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances. It explains the supply behind it: During the shortages, APIs used to compound GLP-1 drug products were supplied by various API manufacturers located around the world, including China, India, and Europe. And the inspection record: Of the 48 GLP-1 API sites FDA evaluated, it found that 21% were noncompliant under section 501 of the FD&C Act, either because their responses to FDA records requests provided evidence of noncompliance with CGMP requirements or because firms did not respond to an FDA records request under section 704(a)(4) in a timely manner.

The green list is the exception inside the alert: Divisions may detain without physical examination (DWPE) shipments of GLP-1 APIs offered for entry, except for the products and firms identified on the Green List of this Alert. The page lists 21 entries with the firm names withheld. Counted by country: China 12, India 3, Belgium 1, Canada 1, Denmark 1, Ireland 1, Italy 1, Portugal 1. A place on it can be lost. FDA wrote to one firm on the list: Your firm was added to the Green List on September 5, 2025, based upon previously provided quality information, in FDA warning letter 723330 to Harbin Jixianglong Biotech Co., Ltd., May 1, 2026.

The alert also explains why the ingredient matters more for a compounded drug than for a manufactured one: Although API manufacturers are subject to CGMP requirements pursuant to section 501(a)(2)(B) of the FD&C Act, compounders whose drugs meet the conditions of section 503A of the FD&C Act are exempt from CGMP requirements, including the requirement to ensure API used in manufacturing meets specifications for impurities or potency, among other things.

What a 503A pharmacy must document

The statute sets the conditions on a bulk ingredient: (ii) that are manufactured by an establishment that is registered under section 360 of this title (including a foreign establishment that is registered under section 360(i) of this title); and (iii) that are accompanied by valid certificates of analysis for each bulk drug substance; FDA restates it: In addition, bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA under section 510 of the FD&C Act. A pharmacy therefore holds a certificate of analysis for each lot and knows who made it. None of the sellers read publishes that certificate for its GLP-1 ingredient or names the maker.

The research label and imported material

FDA's page on unapproved GLP-1 drugs says: FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that are falsely labeled “for research purposes” or “not for human consumption.” Two of the cases on the enforcement page concerned drugs the sellers presented as made in the United States while buying them from China: Paradigm Peptides told customers it manufactured at its own laboratories in the United States, and Milestone Purity's research-labeled products purported to be a Product of the USA.

What this means for S3 and S5

S3 records the pharmacy a seller names, and S5 records a document a reader can check. Neither criterion asks where an ingredient was synthesized, because almost no seller says. A named 503A pharmacy is the step a reader can follow: the ingredient's certificate sits with the pharmacy, not with the storefront. See which pharmacies fill the orders.

Sources

• FDA, Import Alert 66-80
• FDA, launch of the GLP-1 green list, September 5, 2025
• FDA warning letter 723330 to Harbin Jixianglong Biotech Co., Ltd., May 1, 2026
• FDA, concerns with unapproved GLP-1 drugs used for weight loss
• FD&C Act section 503A(b)(1)(A), 21 U.S.C. 353a
• FDA, bulk drug substances used in compounding under section 503A
• U.S. Department of Justice, Paradigm Peptides: Matthew Kawa and Jennifer Stechkober, July 30, 2026
• U.S. Department of Justice, Milestone Purity: Brandon Piper, July 23, 2026
• altRx, its own page
• Amble, its own page
• Avono Health, its own page
• Dollar Dad Club, its own page
• EdgeRx, its own page
• Gala Health, its own page
• GoodGirlRx, its own page
• iThriveMD, its own page
• Leanmeds, its own page
• Medro, its own page
• Nextmeds, its own page
• Pallas Health, its own page
• PeterMD, its own page
• PrescribedRX, its own page
• ReadyRx, its own page
• RNK Health, its own page
• Sprout Health, its own page
• Strut Health, its own page
• System Labs, its own page
• Trinity Meds, its own page
• Whoosh Wellness, its own page
• Yucca Health, its own page
• CoreAge Rx, its own page
• Eden, its own page
• Bayan Health, its own page
• American Peptides, its own page
• Biotech Peptides, its own page
• Limitless Life Nootropics, its own page
• Loti Labs, its own page
• Umbrella Labs, its own page
• Pinnacle Peptides, its own page
• Quality Peptides, its own page
• Peptides For Sale, its own page
• Genesis Peptides, its own page
• The Peptide Store, its own page
• Evolve Peptides, its own page
• Liberty Peptides, its own page
• PS Peptides, its own page
• Actin, its own page
• Ascend Vitality, its own page
• Alinwell, its own page
• Believe Health, its own page
• CLYR Health, its own page
• Coivas, its own page
• Elevated Health, its own page
• Belle, its own page
• Alan Meds, its own page
• Healthon, its own page
• Heros Health, its own page
• Levers Health, its own page
• 50 Stars Health, its own page
• MadeMed, its own page
• Regenics, its own page
• Rylo Health, its own page
• Heally, its own page
• FormBlends, its own page
• Lttl, its own page
• NiceRx, its own page
• PlexusDx, its own page
• YourHealthRx, its own page
• ZYP Medical, its own page
• Arc-1, its own page
• AZ Health, its own page
• Alan Meds, its own page
• Apex MD, its own page
• ElitePhysiqMD, its own page
• Pepti, its own page

Seller pages, the import alert and FDA's pages were read in September 2026. Counts are computed at build time against Standard v1.1; 135 records read printed no origin statement on the pages read.

Counts are generated from the ledger at build time, so this page cannot drift from the records it summarizes. Method and null semantics: how checks are performed. This page ranks nothing, recommends nothing, and carries no partner link.

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