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 sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing medications in larger batches for office use by healthcare practitioners or for distribution to hospitals and clinics, without patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality compounded medications that are essential for patient care. The medications prepared at our 2160 W State Road 434, Longwood, FL 32779 location are manufactured under current good manufacturing practices (cGMP). This ensures every formulation meets rigorous standards for potency, purity, and sterility. Our 503B compounding services are a critical resource for the medical community, offering a reliable supply of essential drugs that may be in shortage or are not commercially available.
Our 503B outsourcing facility is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists and technicians. The environment at 2160 W State Road 434, Longwood, FL 32779 is meticulously controlled to prevent contamination, with stringent quality control procedures in place at every step of the compounding process. This commitment to excellence ensures that every product leaving our facility is of the highest quality and safety, providing healthcare professionals with the confidence they need for their patients.
503B Compounding Pharmacy provides a vital service by addressing drug shortages and producing medications that are no longer available from large-scale manufacturers. The ability of our 503B facility to compound these necessary drugs helps to ensure continuity of care. Healthcare providers can rely on the consistent and compliant output from our location at 2160 W State Road 434, Longwood, FL 32779 to meet the needs of their practice and their patients.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to answer questions and provide support to healthcare facilities and providers regarding our 503B compounded medications.
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 strict federal standards under Section 503B of the FD&C Act. This includes adhering to current Good Manufacturing Practices (cGMP) for the production of compounded human drugs.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners or for distribution to healthcare facilities. Orders are placed by healthcare providers and are not based on individual patient prescriptions. Our services are intended for medical professionals at our location of 2160 W State Road 434, Longwood, FL 32779.
3. How does the quality control process work at your 503B facility?
Our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 implements rigorous quality control testing and procedures as mandated by cGMP standards. This includes testing for sterility, stability, potency, and endotoxins to ensure the safety and efficacy of every batch of medication we compound.
4. Can you compound a medication that is currently on the FDA drug shortage list?
Yes, a primary function of a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 is to compound medications that appear on the FDA’s drug shortage list, helping to mitigate shortages and ensure patient access to critical therapies.
5. How do I place an order or get more information?
Healthcare providers can get more information or place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. You can also visit our website at for additional details about our services at 2160 W State Road 434, Longwood, FL 32779.