What would it take to get peptides on the shelf?
An FDA advisory panel has recommended allowing the production of several peptide therapies, though they remain illegal for compounding pharmacies to manufacture currently. The regulatory process for potential approval is expected to be lengthy, leaving patients in a state of uncertainty.
Why it matters
This highlights the regulatory hurdles and public demand for experimental health treatments that currently exist in a legal gray market.
The peptide saga has reached what could be its most confusing chapter — at least for consumers.
The popular — and experimental — drugs received unprecedented attention in late July during a marathon hearing held by a panel that advises the Food and Drug Administration.
The panel considered whether to back the production of seven different peptide therapies — and voted in favor of all but one — despite concerns raised by the agency's own scientists.
These peptides include some of the most sought-after injectables, BPC-157, TB-500 and MOTS-c.
But that recommendation alone doesn't change the status of these substances. It's still illegal for pharmacies in the U.S. to make these compounds.
The FDA staff and leadership now need to review the data and decide whether compounding pharmacies in the U.S. should be allowed to make any of the seven peptides the panel considered.
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