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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503A vs. 503B Compounding: Choosing the Right Pathway for Peptide Products
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
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The GLP-1 Peptide Crackdown: What Manufacturers Need to Know in 2025
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… Continue Reading
Current Peptide Compliance 