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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, testing, and production, which are distinct from traditional compounding pharmacies. This ensures that healthcare providers at our location receive medications that are consistently produced in large batches for office use, providing a critical component of patient care with a heightened level of safety and reliability.
The core function of 503B Compounding Pharmacy is to supply compounded medications for physician office use. Healthcare professionals in Longwood utilize our services to obtain essential medications that are not commercially available or are in shortage. Our facility at 2160 W State Road 434, Longwood, FL 32779 prepares a range of sterile preparations, including injectables, infusions, and ophthalmics, which are vital for procedures and treatments administered in clinical settings. By operating under strict Current Good Manufacturing Practices (cGMP), we provide a dependable source of high-quality medications that practitioners can trust for their patients.
Our operations at 2160 W State Road 434, Longwood, FL 32779 are defined by a commitment to compliance and quality assurance. The 503B outsourcing facility designation mandates stringent environmental monitoring, sterility testing, and endotoxin testing on all applicable preparations. This scientific, data-driven approach to compounding minimizes risk and provides healthcare providers with the assurance that the medications they use meet exacting standards for potency, purity, and stability. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in aseptic technique and quality control protocols.
503B Compounding Pharmacy serves as a vital partner to the local medical community. Healthcare providers at our location can confidently source medications from our 503B outsourcing facility, knowing they are produced under a framework of federal oversight designed for patient safety. We provide a reliable alternative during drug shortages, ensuring that patient care is not interrupted. For more information about our services or to place an order, please contact 503B Compounding Pharmacy at our facility. Reach us via our website at or by phone at (407)993-1381.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B of the FD&C Act. This registration requires us to comply with stricter federal standards, including Current Good Manufacturing Practices (cGMP), for the production of compounded medications intended for office use by healthcare providers.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy supplies medications for office use to licensed healthcare providers. Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for physicians and practitioners who administer medications within their practice settings.
3. What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in preparing sterile compounded medications, such as injectables, IV bags, and ophthalmics. These are produced in batches for healthcare providers at our location to utilize within their practices for patient procedures and treatments.
4. How does the quality control at a 503B outsourcing facility differ?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under cGMP, which mandates rigorous testing for sterility, potency, and endotoxins. This level of quality control and federal oversight provides an additional layer of safety for the medications we supply to local providers.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place an order by contacting our facility directly. You can reach 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting our website at .