FDA updates guidance on peptide compounding: what changes and when
The August guidance clarifies bulk-substance eligibility and signals enforcement priorities for the next year.
RegulationSemaglutide
Also known as: Ozempic, Wegovy, Rybelsus
ClassGLP-1 receptor agonist
Research statusFDA-approved (branded forms)
CategoryGLP-1 / incretin
Independent tests3
Studies indexed4
Overview
Semaglutide is among the most extensively studied metabolic drugs of the past decade. Large randomized trials (STEP, SUSTAIN programs) demonstrated substantial effects on glycemic control and body weight, establishing GLP-1 receptor agonism as a dominant paradigm in obesity medicine.
The compound is approved and regulated in its branded forms. A significant gray market of compounded and "research" semaglutide has emerged, with wide quality variance — a core focus of our testing program. Our lab program regularly verifies quantity and purity of semaglutide sold outside the pharmacy channel.
Research & Studies
Studies library-
Oral delivery of GLP-1 receptor agonists: absorption-enhancer platforms
Reports improved oral bioavailability for GLP-1-class peptides using next-generation absorption enhancers.
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Tirzepatide versus semaglutide in adults with obesity (SURMOUNT-5)
Direct comparison favoring tirzepatide on weight endpoints at matched treatment intent.
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Semaglutide and cardiovascular outcomes in obesity without diabetes (SELECT)
20% reduction in major adverse cardiovascular events, extending GLP-1 evidence beyond weight and glycemia.
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Once-weekly semaglutide in adults with overweight or obesity (STEP 1)
14.9% mean weight reduction at 68 weeks versus 2.4% with placebo.
Independent Testing
Testing databaseLaboratory verification of Semaglutide products across the companies we index.
Semaglutide Apex Peptides
Purity 99.1% Verified
Semaglutide Sterling Compound Co.
Purity 96.8% Discrepancy
Semaglutide Research Peptides Co.
Purity 98.9% Verified
Latest Coverage
New study explores oral delivery of GLP-1 peptides
Absorption enhancers push oral bioavailability past thresholds previously considered impractical for large peptides.
Research
We Independently Tested 20 Peptide Samples. Here’s What We Found.
Six months, three laboratories, and 20 anonymously purchased samples from 12 companies. Purity ranged from 61% to 99.2% — and two products failed verification entirely.
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