Compounded medication
A 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.
Frequently Asked Questions
What is Compounded medication?
Why is Compounded medication important in peptide research?
Related Terms
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.
503A pharmacyA 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.
Off-label useThe use of an FDA-approved drug for a purpose, population, or dose not specified in its approved labeling. Physicians may legally prescribe off-label. Many peptide uses in clinics are off-label.
Related Peptide Profiles
A GLP-1 receptor agonist FDA-approved for type 2 diabetes (Ozempic) and weight management (Wegovy). Reduces appetite and slows gastric emptying.
TirzepatideA dual GIP/GLP-1 receptor agonist FDA-approved for type 2 diabetes (Mounjaro) and weight loss (Zepbound). Achieves 20–25% body weight reduction in clinical trials.