503A pharmacy
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.
Frequently Asked Questions
What is 503A pharmacy?
Why is 503A pharmacy important in peptide research?
Related Terms
A 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.
Compounding pharmacyA 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.
Compounded medicationA custom-prepared drug made by a compounding pharmacy to meet an individual patient’s needs. Compounded peptides (like compounded semaglutide) exist in a regulatory gray area that the FDA has increasingly scrutinized.