Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
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 precisely 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. As a 503B outsourcing facility, we produce large-scale compounded sterile preparations (CSPs) for healthcare providers, which are then administered to patients in clinical settings. Our core mission is to provide practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to essential medications that are not commercially available, thereby fulfilling a critical need in patient care.
The operational model of 503B Compounding Pharmacy is fundamentally distinct from traditional compounding. Our status as an FDA-registered 503B outsourcing facility mandates adherence to Current Good Manufacturing Practices (cGMP). This rigorous framework governs every aspect of our production at 2160 W State Road 434, Longwood, FL 32779, from the sourcing of active pharmaceutical ingredients (APIs) to final product testing and sterility assurance. This level of oversight provides an additional layer of safety and consistency for the medications we produce. Healthcare professionals can confidently utilize our services, knowing that the sterile preparations they receive from our location meet exacting federal standards for purity, potency, and quality.
Our services are specifically tailored for healthcare entities and practitioners. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides sterile compounded medications in larger volumes for office use. This allows clinics, hospitals, surgical centers, and other healthcare providers to have a reliable supply of critical medications without the burden and expense of in-house compounding. We specialize in a range of preparations, including IV bags, injectables, ophthalmics, and other sterile dosage forms. By outsourcing their compounding needs to our 503B facility, healthcare providers at our location can enhance operational efficiency, reduce potential compounding errors, and reallocate valuable resources directly to patient care.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical professionals. Orders are managed through our dedicated channels, and our team works diligently to ensure timely fulfillment. We encourage all healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to connect with us to discuss their specific medication needs. You can reach our facility directly by phone at (407)993-1381 to speak with a representative. For more comprehensive information about our capabilities, compliance standards, and the process for establishing an account, please visit our official website at https://503bcompoundingpharmacy.com/.
FAQ
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 Section 503B of the FD&C Act. This requires us to follow Current Good Manufacturing Practices (cGMP) for the production of compounded sterile preparations, ensuring a higher level of quality control and sterility assurance compared to traditional pharmacy compounding.
2. Can individual patients pick up prescriptions directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide medications for office use by healthcare providers. Our services are intended for clinics, hospitals, and other healthcare entities at 2160 W State Road 434, Longwood, FL 32779. Individual patients should receive their medications directly from their healthcare provider, who sources from us.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 produce?
Our facility specializes in producing large-scale batches of sterile preparations, such as intravenous (IV) bags, injectable medications, ophthalmic solutions, and other products that require strict aseptic processing. We focus on medications that are on the FDA’s drug shortage list or are not available from commercial manufacturers.
4. How does a healthcare provider at this location place an order with 503B Compounding Pharmacy?
Healthcare providers can contact our facility directly to establish an account and discuss their specific needs. Orders are placed through our dedicated processing system. For details, providers at 2160 W State Road 434, Longwood, FL 32779 can call us at (407)993-1381 or visit https://503bcompoundingpharmacy.com/ for more information.
5. Why should a healthcare provider choose a 503B outsourcing facility over other compounders?
Choosing our 503B facility ensures that the medications you administer are produced under the rigorous cGMP standards enforced by the FDA. This provides an elevated guarantee of product quality, sterility, and consistency, which is crucial for patient safety and risk management for practices at 2160 W State Road 434, Longwood, FL 32779.