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 at 2160 W State Road 434, Longwood, FL 32779
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 large-scale compounding of sterile and non-sterile medications. This designation signifies our adherence to the most rigorous federal standards for quality, safety, and production. Unlike traditional compounding, our 503B status means our medications are produced in bulk for office use by healthcare practitioners, ensuring they have access to critical medications for their patients without the need for a patient-specific prescription.
The core service of 503B Compounding Pharmacy is the provision of office-use medications for physicians, veterinarians, and other healthcare providers whose practices are located at or who serve patients from our local area. We compound a significant volume of medications that are essential for various medical procedures, treatments, and therapies. Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians who follow strict aseptic techniques and rigorous quality control protocols. Every batch of medication we produce undergoes extensive testing to ensure potency, purity, and sterility, providing practitioners with the highest level of confidence in the products they use.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a hub for reliable access to compounded medications that may be commercially unavailable or in short supply. We work directly with healthcare providers to supply medications for their office stock, supporting a wide range of medical specialties. The operational model of a 503B outsourcing facility allows us to provide these medications efficiently and at scale, helping to support the local healthcare infrastructure. For healthcare providers at or near 2160 W State Road 434, Longwood, FL 32779, we serve as a critical partner in patient care.
Contact 503B Compounding Pharmacy at our location on 2160 W State Road 434, Longwood, FL 32779 for more information. You can reach us via our website at or by phone at (407)993-1381. Our team is prepared to assist healthcare professionals with their office-use medication needs.
Frequently Asked Questions for 503B Compounding Pharmacy
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 complies with strict federal current Good Manufacturing Practices (cGMP). This ensures the medications we compound for office use meet the highest standards for quality, sterility, and strength.
2. Can I, as a patient, get a prescription filled directly at your location?
No. 503B Compounding Pharmacy provides medications exclusively for office use by healthcare practitioners. Patients must receive their medications directly from their healthcare provider, who sources our products for use within their practice at 2160 W State Road 434, Longwood, FL 32779 or for their patients in the local area.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide array of sterile and non-sterile medications in bulk quantities. This includes injectables, ophthalmics, topicals, and other formulations that are often used by healthcare providers for procedures, hormone therapy, pain management, and other treatments.
4. How do healthcare providers at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can establish an account with our facility to order medications for their office stock. Orders are placed directly with our pharmacy team. Interested providers can initiate the process by contacting us at (407)993-1381 or through our website at .
5. Why would a healthcare provider choose a 503B outsourcing facility over other compounders?
Healthcare providers choose our services at 2160 W State Road 434, Longwood, FL 32779 because our 503B status guarantees compliance with the most stringent federal manufacturing standards. This provides an added layer of safety and reliability for the medications they use in their practice, especially for sterile injectables and other high-risk formulations.