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 healthcare facilities without patient-specific prescriptions. Our core mission is to provide practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable supply of high-quality compounded drugs.
The operations at our 503B outsourcing facility are distinct from traditional compounding. We are subject to Current Good Manufacturing Practice (CGMP) regulations and undergo regular FDA inspections to ensure our processes meet rigorous federal standards. This level of oversight provides an additional layer of safety and consistency for the medications we produce. The team at our 503B Compounding Pharmacy location is comprised of skilled pharmacists and technicians who are experts in aseptic processing and quality control, ensuring every preparation meets its specified identity, strength, quality, and purity.
Our services at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for healthcare providers. We supply compounded medications to physician offices, hospitals, clinics, and other healthcare entities. The 503B Compounding Pharmacy model allows these providers to obtain necessary medications without the burden of in-house compounding, freeing up valuable resources and ensuring their patients receive medications produced under the most stringent quality controls. We are a critical part of the healthcare supply chain for practitioners based at our location.
Quality assurance is the foundation of everything we do at this 503B Compounding Pharmacy. Every batch of medication is subjected to rigorous analytical testing to verify potency and sterility. Our facility utilizes state-of-the-art equipment and environmental monitoring to maintain the integrity of our cleanrooms. This unwavering commitment to quality ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can have absolute confidence in the medications they administer to their patients.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779 seeking a trusted partner for compounded medications, 503B Compounding Pharmacy offers reliability, quality, and compliance. We invite you to contact us to learn more about our current offerings and how we can support your practice. You can reach us via our website at or by phone at (407)993-1381.
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 an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the FD&C Act. This registration subjects us to federal oversight, including compliance with Current Good Manufacturing Practices (CGMP) and routine FDA inspections.
2. Who can receive medications from this 503B Compounding Pharmacy?
Our 503B outsourcing facility provides medications exclusively to healthcare providers and facilities, such as hospitals, clinics, and physician practices. We do not dispense medications directly to individual patients at 2160 W State Road 434, Longwood, FL 32779.
3. How does the quality control at a 503B outsourcing facility differ?
As a 503B Compounding Pharmacy, we operate under strict CGMP regulations. This requires rigorous batch testing for sterility, potency, and purity before release, along with extensive environmental monitoring and documentation protocols that exceed state-level pharmacy standards.
4. What types of medications does this location compound?
Our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in preparing sterile injectable medications, including IV bags, syringes, and other formulations needed by healthcare providers in a facility-based setting.
5. How can a healthcare facility at this location place an order?
Healthcare providers and facilities can initiate orders by contacting our 503B Compounding Pharmacy directly. Please visit our website at or call us at (407)993-1381 to speak with a representative about our services and ordering process.