Peptides get their regulatory closeup
The FDA is convening an expert panel to evaluate whether compounding pharmacies should be permitted to produce popular injectable peptides. While wellness proponents argue for increased access, experts warn that these substances lack rigorous safety and efficacy testing.
Why it matters
The decision will impact the rapidly growing wellness market and determine the regulatory standards for substances currently sold in a grey market.
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It's a big week for the peptide industry, and the growing number of Americans who've come to embrace the therapies touted for wellness and longevity.
The Food and Drug Administration is convening a panel of outside experts for a two-day meeting starting Thursday to make recommendations on whether compounding pharmacies should be allowed to make some of the most popular injectable peptides.
Health What's behind the push to make peptide therapies more readily available The gathering of the Pharmacy Compounding Advisory Committee is slated to begin early Thursday morning and stretch until Friday afternoon.
The group will review the evidence for seven compounds, including some of the most sought-after injectables: TB-500, BPC-157 and MOTs-C.
None of them have undergone the kind of large-scale trials to establish safety and effectiveness that are required for FDA drug approvals.
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