FDA opens public comment on GLP-1 compounding standards
Regulators want input on how compounded versions of GLP-1 peptides are made and labeled.
by Policy desk
What's on the table
The FDA's draft guidance covers three main areas: source-material traceability, sterility/endotoxin testing requirements, and label disclosure for compounded GLP-1 products.
Comments are open for 60 days. Both industry actors and members of the public can submit through regulations.gov.
Why this matters for buyers
Compounded GLP-1 products have filled gaps during brand-name shortages, but quality has varied widely. Clearer baseline standards would make it easier to tell a reputable compounder from a sketchy one.
If finalized in something close to current form, expect: standardized testing certificates with every batch, clear disclosure when 'salt forms' are used, and tighter rules on marketing language.