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CCPA Submits Comments to FDA on Peptide Compounding

CCPA Submits Comments to FDA on Peptide Compounding

The Chronic Care Policy Alliance (CCPA) submitted comments to the FDA’s Pharmacy Compounding Advisory Committee regarding nomination of several peptide substances for inclusion on the Section 503A Bulks List.

In the letter, CCPA urges FDA not to add the nominated peptide substances to the list at this time. While compounding plays an important role when a patient’s needs can’t be met by an FDA-approved medicine, CCPA emphasizes that it should remain a limited exception, not a routine pathway around FDA’s premarket review for safety, effectiveness, and manufacturing quality. As patient interest in peptide therapies continues to grow, CCPA believes decisions about routine compounding should stay grounded in scientific evidence and patient protection.

See CCPA’s full letter here.