Regulatory Insights
Field-tested guidance on peptide compliance, quality systems, and FDA expectations, covering the regulatory shifts, industry signals, and operational lessons shaping the peptide space right now.
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Lessons from FDA’s First Warning Letter on AI-Generated cGMP Documents
QUICK ANSWER On April 2, 2026, FDA issued Warning Letter 320-26-58 to Purolea Cosmetics Lab — the first publicly released enforcement action that explicitly cites the use of AI agents to draft CGMP documentation.… Continue Reading
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International Peptide Registration: Navigating EMA, MHRA, and Health Canada Requirements
For peptide companies looking beyond the US market, international registration introduces a new layer of regulatory complexity. The European Medicines Agency (EMA), UK’s MHRA, and Health Canada each maintain distinct requirements for peptide products,… Continue Reading
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The 503B Bulks List: What Peptide Compounders Need to Know
The FDA’s list of bulk drug substances that can be used in compounding by 503B outsourcing facilities — commonly known as the “503B Bulks List” — directly determines which peptides can be legally compounded… Continue Reading
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Stability Testing for Peptide APIs: ICH Guidelines and Practical Implementation
Peptide APIs present unique stability challenges that demand careful protocol design and rigorous execution. Degradation pathways including oxidation, deamidation, aggregation, and hydrolysis can compromise both potency and safety. ICH stability guidelines provide the framework,… Continue Reading
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Building a Peptide QMS in 90 Days: A Practical Roadmap
Establishing a quality management system from scratch can feel overwhelming, particularly for peptide startups and smaller compounding operations that lack dedicated regulatory staff. The good news: with the right framework and prioritization, you can… Continue Reading
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FDA Warning Letter Trends in the Peptide Industry: Lessons from 2024
Analyzing FDA warning letters issued to peptide manufacturers and compounding pharmacies reveals clear enforcement patterns that every company in this space should understand. The themes that dominated 2024 enforcement actions point directly to the… Continue Reading
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Adverse Event Reporting for Peptide Products: A Step-by-Step Guide
Adverse event reporting is one of the most critical — and most frequently mishandled — compliance obligations for peptide manufacturers and distributors. The FDA requires timely, accurate reporting of adverse experiences associated with marketed… Continue Reading
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DSCSA Compliance Checklist for Peptide Distributors: Are You Ready?
The Drug Supply Chain Security Act (DSCSA) is now fully enforceable, and peptide distributors face significant obligations around product tracing, verification, and reporting. Non-compliance can result in product holds, import refusals, and FDA enforcement… Continue Reading
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Research Use Only Peptides Under FDA Scrutiny: Enforcement Trends and Compliance Strategies
The “Research Use Only” (RUO) label has long served as a gray-area shield for peptide suppliers seeking to avoid full FDA regulatory oversight. That era is ending. The FDA has dramatically increased enforcement against… Continue Reading
Current Peptide Compliance 