Knowledge Center
Knowledge Center.
Technical notes, synthesis case studies, and supply-chain commentary from our team and our manufacturing partner.
Custom Peptide Manufacturing: How U.S. Law Classifies and Regulates Peptides
A primary-sourced guide to how custom peptides are regulated in the U.S.: the 40-amino-acid drug-vs-biologic line, cGMP under 21 CFR Part 211, and the difference between 503A pharmacies and 503B outsourcing facilities.
Read →Cornerstone Bio Labs vs. Cornerstone Peptide: What the Research-Peptide Label Actually Means
Cornerstone Bio Labs and Cornerstone Peptide are separate, unaffiliated companies. A primary-sourced explainer on how U.S. law classifies research-use peptides, whether BPC-157 is FDA-approved, and how these vials differ from approved drugs like semaglutide and tirzepatide.
Read →What Is a Custom Peptide? The Law, the Synthesis, and the Quality Risk
A primary-sourced guide to custom peptides: the two meanings of the term, the three § 503A conditions a compounded peptide must meet, why the 503A bulks list contains six substances and no peptide, the 40-amino-acid drug-vs-biologic line, and what a 2024 study found in semaglutide bought online.
Read →What Is a Custom Peptide Company? Registration, Labeling, and Legal Exposure
A primary-sourced guide to what a custom peptide company actually is and what U.S. law requires of one: the October 1–December 31 FDA establishment registration window, why the 'not for sale' research exemption fails for sellers, the exact 21 CFR § 312.160 caution and its 2-year recordkeeping duty, the 0.10% impurity-identification threshold, and the 5- and 10-year hGH penalties.
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