Compounded Medication
Quick Definition
A compounded medication is one prepared by a licensed pharmacist for a specific patient, typically because the commercially manufactured product is unavailable, the patient cannot tolerate an inactive ingredient, or a non-standard dose is clinically required. Compounded preparations are not FDA-approved as finished drug products.
In Depth
Compounding pharmacies are regulated under Section 503A (state-licensed traditional compounders) or Section 503B (FDA-registered outsourcing facilities) of the Federal Food, Drug, and Cosmetic Act. Each pathway carries different regulatory standards, scope of authority, and quality requirements.
Section 503A compounders prepare medications for individual patients in response to specific prescriptions. They are licensed by their state board of pharmacy and follow USP <797> sterile compounding standards. They may compound copies of commercially manufactured products only when those products appear on the FDA Drug Shortage List, or when a clinically meaningful difference is documented for an individual patient.
Section 503B outsourcing facilities can prepare batch-scale compounded sterile preparations in advance of specific prescriptions, which they sell to hospitals and clinics. They are FDA-registered, follow Current Good Manufacturing Practice (CGMP) standards, and have a more limited scope of allowable bulk drug substances.
Compounded medications are not FDA-approved as finished drug products. The active pharmaceutical ingredient is sourced from FDA-registered facilities, but the final compounded preparation does not go through the FDA's New Drug Application (NDA) approval pathway that branded products complete.
The most-discussed compounded products in 2024-2025 have been compounded GLP-1s (semaglutide and tirzepatide). Both molecules were on the FDA shortage list, which provided the legal basis for compounding. The FDA declared both shortages resolved in 2024-2025, substantially narrowing the legal authority for 503B outsourcing facilities to compound these products. State-licensed 503A pharmacies retain narrower compounding authority for individualized clinically necessary preparations.
Compounded medications differ from generic drugs. A generic drug is FDA-approved through an Abbreviated New Drug Application demonstrating bioequivalence to the brand. There are no FDA-approved generic versions of currently-on-patent products like semaglutide and tirzepatide. Compounded preparations are a different regulatory category.
Related Terms
Tirzepatide
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered by weekly subcutaneous injection. The FDA approved tirzepatide for type 2 diabetes management in 2022 under the brand name Mounjaro, and for chronic weight management in adults with obesity or overweight with weight-related comorbidities in 2023 under the brand name Zepbound. Compounded tirzepatide formulations, which are prepared by state-licensed compounding pharmacies pursuant to valid prescriptions, are not FDA-approved drug products and differ from the branded versions in formulation, dosing, and regulatory oversight.
Semaglutide
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist FDA-approved for type 2 diabetes (Ozempic, Rybelsus) and chronic weight management (Wegovy). It is administered as a once-weekly subcutaneous injection or as a daily oral tablet, and acts by slowing gastric emptying, increasing satiety signaling, and improving glucose-dependent insulin secretion.
Off-label Use
Off-label use describes a clinically appropriate prescription of an FDA-approved medication for an indication, dose, route, or patient population not specified in the FDA-approved label. Off-label use is legal when prescribed by a licensed clinician but does not carry the FDA's affirmative finding of safety and efficacy for that specific use.