503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are located at 2160 W State Road 434, Longwood, FL 32779, where we provide sterile and non-sterile compounded preparations for healthcare facilities. Our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP) to ensure the highest standards of quality, purity, and potency in all our preparations.
At our location on 2160 W State Road 434, Longwood, FL 32779, our operations are distinct from traditional compounding. As a 503B Compounding Pharmacy, we produce large batches of medications without patient-specific prescriptions, which are then distributed to hospitals, clinics, and healthcare providers for office use. This model ensures that medical professionals at our local healthcare facilities have immediate access to critical medications, including widely used sterile preparations.
The services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are defined by our regulatory status. We specialize in the compounding of various preparations, including intravenous (IV) bags, epidurals, and other injectables that are essential for patient care. Our facility is equipped with state-of-the-art technology and environmental controls to maintain the sterility and integrity of all our compounded preparations. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians dedicated to compliance and precision.
Quality assurance is the foundation of our operation at 2160 W State Road 434, Longwood, FL 32779. Every batch of medication produced by this 503B Compounding Pharmacy undergoes stringent testing and validation processes. This commitment to quality ensures that every preparation leaving our facility meets exacting specifications for safety and efficacy. Healthcare providers can confidently utilize our preparations, knowing they are sourced from a trusted 503B outsourcing facility.
For healthcare facilities seeking a reliable partner for their medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 offers a consistent and compliant supply of essential preparations. We encourage local medical professionals to contact us to discuss their specific requirements. You can reach 503B Compounding Pharmacy at or by phone at (407)993-1381.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. We compound large batches of sterile and non-sterile preparations for office use by healthcare providers, adhering to strict cGMP standards.
2. Can I get a personal prescription filled at 503B Compounding Pharmacy?
No. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications for healthcare facilities, not individual patients. We supply preparations to hospitals, clinics, and physician offices for their inventory and office use.
3. What types of preparations does this 503B facility compound?
Our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in sterile injectable preparations, including IV bags, epidurals, and other medications commonly used in surgical and clinical settings within healthcare facilities.
4. How does the quality control process work at your facility?
Quality control at our 503B Compounding Pharmacy location on 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It includes rigorous environmental monitoring, validation of sterile processes, and thorough testing of finished preparations to ensure they meet all required specifications for potency, sterility, and purity.
5. How can a local healthcare facility place an order?
Healthcare facilities can place an order by contacting 503B Compounding Pharmacy directly. You can reach our team at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting our website at .