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 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 specifically designed and regulated to compound large quantities of sterile and non-sterile medications without receiving patient-specific prescriptions. This regulatory distinction allows us to provide medications in bulk to healthcare providers for office use, ensuring they have essential drugs readily available for their patients. Our operations are subject to rigorous FDA standards, including current good manufacturing practices (cGMP), which guarantees a level of quality, sterility, and safety that goes beyond traditional compounding.
The core function of 503B Compounding Pharmacy is the production of medications that are often in short supply or have been discontinued by major pharmaceutical manufacturers. By compounding these vital drugs, we directly address critical gaps in the pharmaceutical supply chain. Physicians, surgeons, hospitals, and clinics can rely on our Longwood facility as a dependable source for high-quality, compounded medications. Our state-of-the-art cleanrooms and advanced analytical testing equipment ensure every batch we produce meets exacting specifications for potency, purity, and stability.
Our service model is tailored for the medical community. Healthcare professionals at 2160 W State Road 434, Longwood, FL 32779, and the practices they serve, can source necessary medications efficiently. We compound a significant volume of injectable medications, including hormone replacements, ophthalmologic preparations, and other sterile injectables that are essential for various medical procedures and treatments. As a 503B outsourcing facility, we provide a critical link between advanced pharmaceutical compounding and clinical practice, supporting better patient outcomes through reliable access to necessary medications.
For more information or to discuss your facility's needs, please contact 503B Compounding Pharmacy. You can reach us at our website, , or by phone at (407)993-1381. Our team is dedicated to supporting the local medical community with the highest quality compounded pharmaceuticals from our location at 2160 W State Road 434, Longwood, FL 32779.
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 and inspected by the U.S. Food and Drug Administration (FDA). We operate under Section 503B of the FD&C Act, which requires us to adhere to strict current good manufacturing practices (cGMP). This ensures the medications we compound meet heightened standards for sterility, quality, and safety before they are distributed for office use by healthcare providers.
2. Can I, as a patient, get a prescription filled directly at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy does not accept individual patient prescriptions. Our facility compounds medications in larger batches for healthcare providers to keep in their offices for administration to their patients. Patients should have their prescriptions filled at a traditional 503A compounding pharmacy or a retail pharmacy.
3. What types of medications does 503B Compounding Pharmacy produce?
Our primary focus is on compounding medications that are on the drug shortage list or are no longer available from commercial manufacturers. This includes a wide array of sterile injectable medications, such as hormone therapy injections, vitamin complexes, and ophthalmic solutions. All products are compounded at our facility located at 2160 W State Road 434, Longwood, FL 32779.
4. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers and facilities can place orders directly with 503B Compounding Pharmacy. We work with physicians, clinics, and hospitals to supply them with the compounded medications they need for their practice. To begin an order or inquire about our available products, providers can contact us at (407)993-1381.
5. Why should a medical practice source medications from a 503B outsourcing facility?
Sourcing from a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779, provides assurance of quality and compliance. Our FDA-registered status and adherence to cGMP standards mean medical practices receive medications that have undergone rigorous testing for potency, sterility, and endotoxins. This reduces risk and provides a reliable supply of essential drugs that may otherwise be unavailable.