USP 797 / USP 795
Pharmacopoeial standards governing sterile (USP 797) and non-sterile (USP 795) compounding
Definition
USP 797 establishes standards for sterile compounding, addressing clean-room design, equipment, training, beyond-use-dating and testing requirements. USP 795 covers non-sterile compounding. Together, these form the operational backbone of 503A compounding pharmacies. Peptide injectables require USP 797 compliance.
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503A Pharmacy
A US compounding pharmacy that prepares medications for individual patients based on a specific prescription.
Pharmacy & RegulationcGMPCurrent Good Manufacturing Practice
FDA-enforced manufacturing standards for pharmaceutical products. 503A compounders operate under USP 795/797 standards rather than full cGMP.
Pharmacy & RegulationCompounded Peptide
A peptide prepared for an individual patient by a licensed compounding pharmacy, prescribed by a clinician and tested for identity, potency and contamination.
$149 panel.
A clinician reads it in 24 hours.
Order the Peptide Readiness Panel, draw at a Quest or LabCorp near you, and your clinician sends back a matched protocol with a confidence score.