The US Food and Drug Administration (FDA) is expected to lift restrictions on certain injectable peptides, which would allow compounding pharmacies to produce them again.
The agency had removed more than a dozen peptides from the compounding list in 2023 due to concerns related to safety, including risks of immunogenicity, toxicity, and impurities.
The expected move would reverse this decision and enable compounding pharmacies to resume production of these peptide-based therapies.
Peptides are short chains of amino acids and are used in various therapeutic applications.
The development is linked to discussions within US health authorities regarding access to peptide treatments.
The Department of Health and Human Services has not commented on the expected change.
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