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 compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that our processes and products meet an elevated level of consistency and reliability for the healthcare providers and patients we serve at our Longwood location.
The core service of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are distributed to healthcare facilities for office use. Our operations at 2160 W State Road 434 are designed to support local clinics, hospitals, and medical practices by providing them with a consistent, high-quality supply of essential medications that may be commercially unavailable or in shortage. By functioning as a 503B outsourcing facility, we provide physicians with access to necessary medications for their patients without the individual practitioners needing to perform the compounding themselves, thereby enhancing patient safety and streamlining clinical operations.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced environmental controls and technology to ensure the integrity of every preparation. Our team of highly trained pharmacists and technicians adheres to exacting sterility testing and quality assurance protocols mandated for all 503B outsourcing facilities. Every batch of medication is compounded under stringent conditions and undergoes rigorous testing to verify potency, purity, and sterility before it is released for distribution. This meticulous process provides healthcare professionals at our local Longwood address with the confidence that the medications they administer meet the highest possible standards.
503B Compounding Pharmacy is dedicated to being a reliable partner for the medical community at 2160 W State Road 434. We understand the critical need for medications that are not readily available from standard commercial manufacturers. Our role is to bridge that gap, ensuring that patient care is not interrupted by drug shortages or the need for a specific formulation. We invite local healthcare providers to learn more about how our 503B compounding services can support their practice. For more information or to discuss your specific needs, please contact us via our website 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 is an FDA-registered outsourcing facility. We operate under Section 503B of the Federal Food, Drug, and Cosmetic Act, which subjects us to federal oversight and current Good Manufacturing Practice (cGMP) regulations. This ensures a higher level of quality control and consistency for the medications we compound compared to a traditional pharmacy.
2. Who can receive medications from 503B Compounding Pharmacy? As a 503B outsourcing facility, we primarily distribute compounded medications to healthcare facilities and practitioners for "office use." This means we supply medications to doctors, clinics, and hospitals at 2160 W State Road 434 and the immediate vicinity for them to administer to patients within their practice, rather than dispensing directly to individual patients.
3. What types of medications does 503B Compounding Pharmacy prepare? We compound a wide range of sterile and non-sterile medications that are often on shortage or are not commercially available. This includes injectables, ophthalmics, and other formulations required by healthcare providers serving the Longwood community from our location at 2160 W State Road 434.
4. How does the quality assurance process work at your facility? Our quality assurance process is extensive. Every batch of medication compounded at our 2160 W State Road 434 location undergoes rigorous testing for sterility, potency, and purity as required by FDA cGMP standards for 503B outsourcing facilities. This ensures every product we release is safe, effective, and of the highest quality.
5. How can a healthcare provider at 2160 W State Road 434 place an order? Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach us by phone at (407)993-1381 or through our website at . Our team will work with you to fulfill your specific medication requirements.