Glossary
Compounding Pharmacy
Compounding pharmacies make patient-specific medicines under US FDCA sections 503A and 503B. How the two categories differ and why the peptide rules changed.
A compounding pharmacy is a pharmacy holding a state licence that makes up a medicine to order instead of handing out a manufacturer’s finished product. In the United States the activity is divided into two categories. Under Section 503A, traditional compounding is performed on a valid prescription for a named patient; such pharmacies are exempt both from cGMP manufacturing rules and from FDA approval. Section 503B outsourcing facilities — introduced by the Drug Quality and Security Act of 2013 in response to the 2012 NECC meningitis outbreak — can produce batches without patient-specific prescriptions, but they have to register with FDA and follow cGMP.
Relevance for a peptide catalogue
Compounded products are prescription medicines; they are not FDA-approved drugs and they are not research chemicals either. The bulk ingredient has to be on an approved list or be part of an approved drug — the route through which several peptides lost their compounding eligibility after FDA assigned them to category 2 in 2023. In a separate development, compounding of GLP-1 analogues was allowed while those medicines were listed in FDA’s shortage database, and was phased out once the shortages ended in 2025.
Peptide Medix EU is not a pharmacy and carries out no compounding. Products from this site are shipped without prescriptions and without any 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.