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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are held to the highest standards of pharmaceutical compounding, producing large quantities of sterile and non-sterile medications for healthcare providers. Our mission is to provide healthcare practitioners with access to high-quality, compounded medications that are essential for patient care.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under strict regulatory oversight. This includes compliance with Current Good Manufacturing Practices (cGMP), which ensures every batch of medication is produced with consistent quality, purity, and strength. Our state-of-the-art facility is designed to meet these rigorous standards, featuring controlled environments for sterile compounding and a dedicated team of qualified pharmacists and technicians. We serve as a critical partner to local healthcare providers by supplying them with medications that are often unavailable from traditional manufacturers.
Our services at the 2160 W State Road 434 location are specifically tailored for healthcare providers. We produce a range of medications, including sterile injectables, ophthalmics, and other formulations that are in shortage or are not commercially available. By focusing on bulk compounding, the 503B Compounding Pharmacy ensures a reliable supply of essential drugs, helping to support the local medical community and, by extension, the patients they serve in our immediate area.
For healthcare providers seeking a trusted partner for compounded medications, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a dedicated resource. We prioritize safety, quality, and reliability in every preparation. For more information or to discuss your needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
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 of the FD&C Act. We compound large volumes of sterile and non-sterile medications and are required to comply with stringent federal manufacturing standards, including Current Good Manufacturing Practices (cGMP).
2. Who can order medications from this 503B Compounding Pharmacy?
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare providers, including hospitals, clinics, and physician practices. We supply medications for office use and administration to patients within their care.
3. Does the 503B Compounding Pharmacy serve individual patients directly?
No, our facility at 2160 W State Road 434, Longwood, FL 32779 operates as a bulk manufacturer for healthcare providers. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. We supply medications to practitioners for use in their practice.
4. What types of medications does this location compound?
Our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in producing sterile injectables, ophthalmics, and other formulations that are on drug shortage lists or are not available from standard pharmaceutical manufacturers.
5. How can a healthcare provider place an order with your facility?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. You can reach the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or through our website at . Our team will guide you through the requirements and ordering process.