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 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 current Good Manufacturing Practices (cGMP) and undergoes regular FDA inspections, ensuring that every preparation meets stringent federal requirements for strength, identity, quality, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations for healthcare facilities. Our operations at 2160 W State Road 434, Longwood, FL 32779 are designed to provide physicians, hospitals, clinics, and other healthcare providers with a reliable, bulk supply of medications that are often on shortage or are not commercially available. By outsourcing their compounding needs to our 503B facility, healthcare providers can significantly reduce the risks associated with in-house compounding, freeing up valuable resources and ensuring their patients receive consistently formulated medications of the highest quality.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced environmental controls, including ISO-classified cleanrooms, to ensure the sterility and stability of all our preparations. Our highly trained pharmacists and technicians utilize precision equipment and validated processes to compound a wide array of medications, including intravenous bags, hormone therapy preparations, ophthalmics, and other essential injectables. Every batch is thoroughly tested and documented, providing an unparalleled level of traceability and assurance for the healthcare providers we serve.
503B Compounding Pharmacy provides a critical service to the medical community by addressing and mitigating drug shortages. When a vital medication is unavailable from conventional manufacturers, our facility can often compound it, helping to prevent interruptions in patient care. The team at our Longwood location is dedicated to supporting healthcare providers with responsive service, regulatory expertise, and a steadfast commitment to patient safety through superior compounding practices.
For more information about our services or to discuss your facility's specific needs, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance standards 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 operates under Section 503B of the FD&C Act. This subjects us to federal oversight, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the highest levels of quality, sterility, and safety in our compounded preparations.
2. Who can receive medications from 503B Compounding Pharmacy?
As a 503B outsourcing facility, we provide compounded medications primarily to healthcare providers and facilities—such as hospitals, clinics, and physician practices—by prescription for their patients. We do not typically compound medications for individual patients directly; instead, we support the healthcare providers at 2160 W State Road 434, Longwood, FL 32779 who prescribe and administer these medications.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in preparing large-scale batches of compounded sterile preparations (CSPs), including intravenous (IV) medications, epidurals, ophthalmics, and injectable hormones. We also compound non-sterile preparations, all produced under strict cGMP guidelines to ensure consistency and reliability for healthcare providers.
4. How does 503B Compounding Pharmacy help with drug shortages?
When commercially manufactured drugs go on shortage, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can often compound those essential medications in bulk. This provides a critical alternative for healthcare providers, helping to ensure continuous patient care without interruption due to supply chain issues.
5. How can a healthcare facility at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers and facilities can initiate an order or discuss their specific compounding needs by contacting 503B Compounding Pharmacy directly. You can reach our team by phone at (407)993-1381. Our experts will work with you to understand your requirements and provide the necessary compounded medications.