cGMP
Also known as Current Good Manufacturing Practice
FDA-enforced manufacturing standards for pharmaceutical products. 503A compounders operate under USP 795/797 standards rather than full cGMP.
Definition
Current Good Manufacturing Practice refers to the FDA's enforced quality standards for pharmaceutical manufacturing — facility design, equipment, personnel qualification, process validation, quality control. Meto's 503A pharmacy partners operate under USP 795 and USP 797 compounding standards, which are tailored to patient-specific compounding workflows. Every batch is also third-party tested for identity, potency, endotoxins and microbial contamination.
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503A Pharmacy
A US compounding pharmacy that prepares medications for individual patients based on a specific prescription.
Pharmacy & RegulationUSP 797 / USP 795
Pharmacopoeial standards governing sterile (USP 797) and non-sterile (USP 795) compounding
Pharmacy & RegulationFDAFood and Drug Administration
The US regulatory body for drugs, devices and compounding pharmacies — the agency that classifies which peptides may be compounded.
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