Compounding pharmacy
A pharmacy that custom-prepares medications, including peptides, based on a prescriber’s specific order. Compounded peptides are made to order rather than mass-manufactured. Regulated under 503A or 503B frameworks.
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Related Terms
A traditional compounding pharmacy that prepares medications based on individual prescriptions. 503A pharmacies are state-regulated, require a patient-specific prescription, and do not need FDA registration.
503B outsourcing facilityA compounding facility registered with the FDA that can produce large batches without patient-specific prescriptions. Subject to FDA inspection, current good manufacturing practices (cGMP), and adverse event reporting.
Pharmaceutical gradeThe highest quality standard for a peptide, meeting regulatory requirements for human use. Purity exceeds 99%, with documented manufacturing processes, quality controls, and endotoxin testing.