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

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

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

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

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

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

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

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

The distinction between Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act defines two fundamentally different regulatory pathways for compounding pharmacies producing peptide products. Choosing the wrong pathway — or… Continue Reading