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 operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent federal quality standards for sterility, potency, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare facilities. We provide these essential medications to physician offices, hospitals, clinics, and surgical centers that utilize our services at 2160 W State Road 434, Longwood, FL 32779. Our operations are designed to support the local medical community by alleviating the burden of in-house compounding, allowing healthcare providers to focus on patient care. We compound medications that are currently in shortage or are not commercially available, ensuring that patients receive the critical treatments they need without interruption.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology, including ISO-classified cleanrooms. Our highly trained pharmacists and technicians adhere to exacting protocols to prevent contamination and ensure the integrity of every preparation. The process involves meticulous validation of components, precise environmental monitoring, and comprehensive quality control testing. By operating as a 503B outsourcing facility, we provide a level of assurance and reliability that is critical for injectable and other sterile medications used in patient care.
503B Compounding Pharmacy is dedicated to serving the specific needs of the healthcare providers who partner with us at our Longwood location. We understand the critical nature of the medications we produce and the importance of timely delivery and consistent quality. Our team works diligently to maintain a robust inventory of raw materials and to fulfill orders efficiently, supporting the continuity of care for patients in our community. For more information or to inquire about our services, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring a higher level of quality control and consistency for the sterile medications we compound.
2. Who can receive medications from 503B Compounding Pharmacy?
As a 503B outsourcing facility, we provide compounded medications primarily to healthcare practitioners for office use and for administration within their practice settings at 2160 W State Road 434, Longwood, FL 32779. This includes physicians, hospitals, clinics, and other healthcare entities. We do not typically dispense medications directly to individual patients without a prescription presented by a licensed practitioner.
3. What types of medications does 503B Compounding Pharmacy prepare?
We specialize in compounding sterile preparations, which are often injectable medications. This includes formulations that are on the FDA drug shortage list or medications that are not commercially available from large pharmaceutical manufacturers. Our services are tailored to meet the specific needs of the healthcare providers we serve from our location at 2160 W State Road 434.
4. How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434 is comprehensive. It includes rigorous testing of components, environmental monitoring of our ISO-classified cleanrooms, validation of sterilization processes, and end-product testing for sterility and potency. This multi-layered approach is mandated by cGMP regulations and is fundamental to our operation as a 503B outsourcing facility.
5. How can a healthcare provider at your location place an order?
Healthcare providers interested in utilizing our services can initiate the process by contacting our facility directly. We will provide the necessary documentation and information for establishing an account. You can reach our team for more details by visiting our website at or by calling us at (407)993-1381.