Pharmacies that compound medications fall into two main categories: 503A and 503B pharmacies. Each type operates under distinct regulations and serves different purposes within the healthcare system.
503A Pharmacy
A 503A pharmacy is a traditional compounding pharmacy that prepares medications for individual patients based on specific prescriptions. These pharmacies operate under the Drug Quality and Security Act (DQSA) and are primarily regulated by state boards of pharmacy. They must comply with United States Pharmacopeia (USP) standards, specifically:
USP <795> – Guidelines for non-sterile compounding
USP <797> – Standards for sterile compounding to ensure medication safety
USP <800> – Regulations for handling hazardous drugs to protect patients and healthcare workers
Key characteristics of 503A pharmacies include:
✅ Patient-Specific Medications – Each compounded medication must be prescribed for an individual patient.
✅ State-Regulated – Primarily overseen by state pharmacy boards, though the FDA may inspect them if needed.
✅ Smaller Batch Production – Medications are prepared in small quantities based on demand.
📌 Source: U.S. Food and Drug Administration (FDA) - Compounding and the Drug Quality and Security Act (DQSA)
503B Pharmacy
A 503B pharmacy, also known as an outsourcing facility, is a large-scale compounding pharmacy that produces medications in bulk for distribution to healthcare facilities without requiring individual patient prescriptions.
503B facilities are registered with the FDA and must comply with Current Good Manufacturing Practices (CGMP), the same rigorous quality and sterility standards used by major pharmaceutical manufacturers. These standards include:
Strict sterility and potency testing before products are released.
Batch testing for consistency and safety to ensure quality.
Regular FDA inspections to maintain compliance with federal guidelines.
Key characteristics of 503B pharmacies include:
✅ Bulk Manufacturing – Medications are compounded in large quantities and distributed to hospitals, clinics, and healthcare providers.
✅ FDA-Regulated – Subject to routine FDA inspections and must comply with CGMP requirements.
✅ Higher Standards for Safety & Quality – Medications undergo extensive sterility and potency testing to ensure consistency, stability, and efficacy.
Because 503B pharmacies follow higher manufacturing and safety standards, they reduce the risk of contamination and variability commonly found in small-scale compounding pharmacies.
📌 Source: U.S. Food and Drug Administration (FDA) - Outsourcing Facilities (503B) and CGMP Compliance
Key Differences at a Glance
Feature | 503A Pharmacy | 503B Pharmacy |
Regulation | State Boards of Pharmacy | FDA & CGMP |
Prescription Requirement | Required for each patient | Not required; bulk distribution |
Production Scale | Small-scale, patient-specific | Large-scale, bulk production |
Sterility Testing | Limited | Extensive & required |
FDA Inspections | Rare | Regular & mandatory |
Compliance Standards | USP <795>, <797>, <800> | CGMP & FDA guidelines |
Quality Control | Varies by pharmacy | Standardized & regulated |