Current Peptide Compliance

The FDA’s intensified scrutiny of GLP-1 receptor agonist peptides — including semaglutide and tirzepatide — has reshaped the compliance landscape for manufacturers and compounding pharmacies. With demand skyrocketing and enforcement actions mounting, understanding the current regulatory posture is essential for any company in this space.

The Enforcement Wave

Since late 2023, the FDA has issued dozens of warning letters to compounding pharmacies and peptide suppliers producing GLP-1 analogs. The agency has made clear that compounding copies of commercially available GLP-1 products raises significant safety and legal concerns, particularly when those products are not on the FDA Drug Shortage List.

The central issue is straightforward: under federal law, 503A and 503B compounders may only compound copies of commercially available drugs when those drugs appear on the official shortage list. Once a GLP-1 product is removed from shortage status, compounding becomes legally precarious.

Key Compliance Requirements

For manufacturers and distributors still operating in the GLP-1 space, several compliance fundamentals must be in place. First, robust identity testing of incoming peptide APIs is non-negotiable — the FDA has flagged multiple cases of misidentified or subpotent active ingredients. Second, stability data must support your assigned beyond-use dates, particularly for compounded sterile preparations. Third, adverse event reporting systems must be operational and responsive, as the agency is actively monitoring safety signals from compounded GLP-1 products.

What You Should Do Now

Companies currently manufacturing or distributing GLP-1 peptides should immediately review their regulatory status and ensure their operations align with current FDA guidance. This means verifying shortage list status before each compounding run, maintaining rigorous batch records, and having a documented plan for ceasing production if shortage status changes.

FAQ: GLP-1 Compliance

Can I still compound semaglutide? Only if semaglutide remains on the FDA Drug Shortage List at the time of compounding. Check shortage status before every production run.

What testing do I need for GLP-1 APIs? At minimum: identity, purity, potency, and endotoxin testing. Certificate of Analysis from the supplier is not sufficient on its own.

What happens if I receive a warning letter? Respond within 15 business days with a corrective action plan. Consider engaging regulatory counsel immediately.

Need help navigating GLP-1 compliance? Current Peptide Compliance provides regulatory strategy and SOP packages specifically designed for peptide compounders. Contact us for a free consultation.