A compounding pharmacy is a state-licensed pharmacy that prepares a medication to order rather than dispensing a manufacturer's finished product. US law splits the activity in two. Section 503A covers traditional compounding against a valid prescription for an identified patient; these pharmacies are exempt from cGMP manufacturing requirements and from FDA approval. Section 503B outsourcing facilities, created by the Drug Quality and Security Act of 2013 after the 2012 NECC meningitis outbreak, may prepare batches without patient-specific prescriptions but must register with FDA and comply with cGMP.
Why this matters in a peptide catalog
Compounded preparations are prescription medications; they are neither FDA-approved products nor research chemicals. The bulk substance must appear on an approved list or be a component of an approved drug, which is the mechanism by which several peptides were removed from permitted compounding after FDA category 2 designations in 2023. Separately, compounding of GLP-1 analogues was permitted while those drugs were on the FDA shortage list and was wound down as shortages resolved in 2025.
MyPeptide is not a pharmacy and does not compound. Material here is supplied research use only, without prescriptions or patient-specific preparation.
Related terms and material
telehealth peptide prescription · gray-market vendor · third-party testing. Further reading: the GLP-1 compounding crackdown and telehealth vs research-grade.