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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of compounded sterile medications. This designation signifies our adherence to the highest standards of quality, safety, and testing, which are more rigorous than those required for traditional 503A compounding pharmacies. We serve a critical role for healthcare providers by producing large-scale batches of medications without patient-specific prescriptions, which are then distributed to healthcare facilities for office use.
The core function of 503B Compounding Pharmacy is the production of sterile injectable medications. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced cleanroom technology and environmental monitoring to ensure every preparation meets stringent sterility assurance levels. All processes are governed by current Good Manufacturing Practices (cGMP), which enforce consistency, purity, and strength in every batch we compound. This level of quality control provides healthcare professionals with confidence in the medications they administer to their patients.
Healthcare providers in need of office-use medications can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. We provide essential medications that are often on shortage from larger commercial manufacturers, helping to ensure continuity of care. Our team of highly trained pharmacists and technicians is committed to excellence, from the sourcing of pure ingredients to the final testing and release of each batch. By partnering with our 503B outsourcing facility, medical practices can access a reliable source of high-quality compounded preparations.
Contact 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 to learn more about our services and how we can support your practice. You can reach us by phone at (407)993-1381 or visit our website at . Our team is prepared to answer your questions and provide information on our available formulations and ordering process.
FAQ
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. We compound large batches of sterile medications for office use by healthcare providers and are required to comply with stricter federal standards, including current Good Manufacturing Practices (cGMP), which involve rigorous testing for sterility, potency, and purity.
2. Can I as an individual patient get a prescription filled at this location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 does not compound patient-specific prescriptions. We provide medications in larger batches for healthcare providers to use within their practice. Individual patients should contact a traditional 503A compounding pharmacy for their personal prescription needs.
3. Who is eligible to order from your 503B outsourcing facility?
Orders are accepted from licensed healthcare providers and healthcare facilities. Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for office-use medications that a provider may need to have on hand for procedures or treatments within their practice.
4. How does the quality control at a 503B outsourcing facility differ?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under cGMP, which mandates extensive quality control. This includes validated processes, environmental monitoring, and testing of each batch for sterility, endotoxins, potency, and stability before it is released, providing an additional layer of safety beyond traditional compounding.
5. How can a healthcare provider place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 will provide information on our available medications, minimum order quantities, and the process for establishing an account.