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 current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous quality and safety protocols. This designation distinguishes our operations from traditional compounding pharmacies and underscores our commitment to providing healthcare providers with reliable, large-scale compounded pharmaceutical products.
The core function of 503B Compounding Pharmacy is to support the medical community by producing medications that are not commercially available. This includes creating formulations without certain allergens like dyes or preservatives, adjusting dosages to meet specific patient needs, or compounding a medication that is currently on shortage. Our work at the 2160 W State Road 434 location is pivotal for hospitals, clinics, and other healthcare entities that require bulk quantities of compounded preparations for their patient populations. We serve as a critical partner in the healthcare supply chain, ensuring that practitioners have access to essential medications.
Quality control is the foundation of everything we do at 503B Compounding Pharmacy. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to prevent contamination and ensure sterility. Every batch of medication undergoes extensive testing and validation processes before it is released. This meticulous attention to detail guarantees that healthcare providers at our location can administer our products with the utmost confidence. Our team of highly trained pharmacists and technicians utilizes advanced technology and follows strict aseptic techniques to uphold the integrity of every preparation.
While 503B Compounding Pharmacy primarily serves healthcare institutions, our presence at 2160 W State Road 434, Longwood, FL 32779 is a vital resource for the local medical infrastructure. We provide a dependable source for compounded medications, helping to mitigate drug shortages and support specialized treatment plans. For more information about our services or to discuss your specific needs, you can reach us via our website at or by phone at (407)993-1381. 503B Compounding Pharmacy is committed to excellence in compounding for the healthcare providers we serve.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
Being an outsourcing facility under Section 503B means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stricter production standards, known as current good manufacturing practices (cGMP), compared to a traditional pharmacy. This ensures a higher level of quality control and safety for the compounded medications we produce.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily provides compounded medications in larger quantities to healthcare providers and facilities, such as hospitals, clinics, and physician offices. Orders are placed by medical professionals for their patients at our location on 2160 W State Road 434, Longwood, FL 32779.
3. Does 503B Compounding Pharmacy serve individual patients directly?
Our primary business model at 2160 W State Road 434, Longwood, FL 32779 is to supply healthcare institutions. Individual patients should consult with their healthcare provider, who can then determine if our compounded medications are appropriate and place an order on their behalf.
4. How does 503B Compounding Pharmacy ensure medication safety?
At our facility on 2160 W State Road 434, Longwood, FL 32779, we implement rigorous cGMP protocols. This includes environmental monitoring, validated sterility testing, and stringent quality assurance checks throughout the entire compounding process to ensure every preparation is pure, potent, and safe.
5. How can a healthcare provider at your location place an order?
Healthcare providers interested in our services can initiate the process by contacting 503B Compounding Pharmacy directly. Please visit our website at or call us at (407)993-1381 to speak with a representative about your compounding needs at our 2160 W State Road 434, Longwood, FL 32779 facility.