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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, testing, and production, beyond those required of traditional compounding pharmacies. We provide these bulk compounded medications to healthcare providers and practitioners for office use, ensuring they have the necessary supplies to treat their patients effectively and safely.
The core function of 503B Compounding Pharmacy is to serve as a reliable source for practitioners at 2160 W State Road 434, Longwood, FL 32779. We compound prescription medications that are not commercially available, whether due to drug shortages, discontinuations, or the need for a specific strength or formulation not offered by pharmaceutical manufacturers. Our state-of-the-art facility employs rigorous sterility testing, analytical chemistry, and environmental monitoring to guarantee the potency, purity, and safety of every preparation that leaves our location. This commitment to excellence provides healthcare professionals with the confidence that the medications they administer meet exacting quality standards.
Healthcare providers and practitioners can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 for a consistent supply of essential medications. Our operations are designed to support medical practices by alleviating the burden of in-office compounding, allowing practitioners to focus on patient care. By outsourcing their compounding needs to our 503B outsourcing facility, practitioners gain access to a wide array of preparations, including sterile injectables, ophthalmics, and other dosage forms, all produced under a comprehensive quality management system as mandated by the FDA.
Contact 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 to learn more about our services and how we can support your practice. You can reach us via our website at or by phone at (407)993-1381. Our team is prepared to provide information on our current product offerings and compliance protocols.
FAQ
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 complies with strict federal current Good Manufacturing Practices (cGMP). This ensures the medications we compound undergo rigorous testing for sterility, potency, and purity.
Who can order medications from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare practitioners and providers. We supply compounded medications for office use; these medications are not dispensed directly to individual patients without a prescription from their provider.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile preparations in larger quantities. This includes medications often used in offices and clinics, such as sterile injectables, ophthalmics, and other formulations that may be affected by drug shortages.
How does the quality control at a 503B outsourcing facility differ?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under federal cGMP standards, which mandate extensive testing, environmental monitoring, and quality assurance procedures that exceed the standards applied to traditional 503A compounding pharmacies.
How can a practitioner at this location place an order?
Healthcare practitioners interested in our services can contact 503B Compounding Pharmacy directly at our location, 2160 W State Road 434, Longwood, FL 32779, by calling (407)993-1381 or visiting our website at . Our team will provide ordering information and discuss your specific needs.