What Is a 503A Pharmacy?
A 503A pharmacy is a traditional compounding pharmacy that makes medications for individual patients based on specific prescriptions from licensed providers. These pharmacies are regulated primarily by state boards of pharmacy and must follow USP standards for compounding safety and quality.
Key traits of a 503A pharmacy:
- Clinic has to write patient specific prescriptions for medication
- Not permitted to distribute for office use
- Shorter beyond-use dates (BUDs)
- Best suited for telehealth and/or patients who can't come to the office
- Required by the state boards of pharmacy to comply with USP 797 Guidelines
What Is a 503B Pharmacy?
A 503B pharmacy, also known as an outsourcing facility, operates more like a pharmaceutical manufacturer. These facilities are registered with the FDA and follow current Good Manufacturing Practices (cGMP)—the same rigorous standards used by major drug manufacturers.
Key traits of a 503B pharmacy:
- Can produce medications in bulk (batch production)
- Office stock inventory (no patient-specific prescription required)
- Held to higher manufacturing standards than 503A
- Performs lot-level testing for sterility, potency, and stability
- Provides extended BUDs, standardized formulations, and COAs (Certificates of Analysis)