Status first
Approved, lawfully compounded, investigational, and research-use-only are not interchangeable labels.
Evidence framework · v.01
We track the exact compound, product, route, population, endpoint, study design, and regulatory status. “Promising” is a starting point—not a conclusion.
Approved, lawfully compounded, investigational, and research-use-only are not interchangeable labels.
Laboratory findings, animal studies, observational data, and randomized human trials answer different questions.
Small samples, surrogate endpoints, missing comparators, and conflicts belong beside the headline—not in fine print.
Evidence library · first records
Last reviewed July 24, 2026. Verify time-sensitive status at the source.
FDA-approved peptide medicine
Approval applies to specific products, formulations, doses, and indications—not every product sold under a similar name.
Primary source: Drugs@FDAFDA-approved peptide medicine
Compounded or research-use-only versions should not be treated as equivalent to an FDA-approved product.
Primary source: Drugs@FDAUnapproved compound
FDA identifies potential immunogenicity and impurity-characterization concerns and says it lacks sufficient safety information for proposed routes.
Primary source: FDA compounding safety risksWhat a COA can—and cannot—tell you
A certificate of analysis may report the identity, purity, mass, or other characteristics of a tested sample. It does not, by itself, establish FDA approval, clinical efficacy, appropriate dosing, sterility, safe human use, or that every vial sold matches the tested sample.
Useful review questions include: Who commissioned the test? Is the laboratory identified and independently accredited for the method? Do the product lot and sample identifiers match? What methods and detection limits were used? Is there identity testing as well as a purity percentage? Was sterility or endotoxin testing performed when relevant to the stated laboratory application?