FDA presses APC on technical details of peptide compounding proposal
APC wants interim enforcement discretion for patient-specific compounding of selected peptides, with cGMP-sourced ingredients, disclosures and adverse-event reporting.
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By Daniel Okafor · Regulatory Correspondent
Oct 2 09:48 ETSource: a4pc.org
The wire
- 01At a Monday listening session, APC's Philip Smyth, Tenille Davis and Scott Brunner presented proposed guardrails for peptide compounding, with Emory's Dr. Donghai Liang outlining a limited utilization reporting framework.
- 02If FDA adopts an interim framework, 503A pharmacies could compound selected peptides patient-specifically under validated sourcing, USP-compliant preparation, enhanced patient disclosures and serious adverse-event reporting.
- 03Brunner said his sense after two listening sessions is that FDA is seriously considering such a framework; no agency commitment, timeline or peptide list has been announced.
From the source
Read at a4pc.orgFDA digs into APC’s peptide proposal
Monday’s listening session with FDA staff brought a substantive discussion of APC’s proposed guardrails for peptide compounding, with several incisive questions about technical details. Board Chair Philip Smyth, Advocacy Chief Tenille Davis, and CEO Scott Brunner presented for APC. Research partner Dr. Donghai Liang of Emory University’s Rollins School of Public Health also presented a framework f
