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. We are a specialized pharmacy located at 2160 W State Road 434, Longwood, FL 32779, dedicated to the large-scale, non-patient-specific compounding of sterile and non-sterile medications. Our core mission is to provide healthcare providers with access to high-quality, compounded medications that are essential for patient care but may be commercially unavailable or in short supply. As a 503B outsourcing facility, we adhere to the most stringent federal standards for quality control, sterility assurance, and testing, offering a critical alternative to traditional compounding pharmacies and standard pharmaceutical manufacturers.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is designed and maintained to meet rigorous FDA compliance standards. This includes state-of-the-art cleanrooms with controlled environments to prevent contamination, advanced analytical testing equipment to verify the potency and purity of every batch, and a highly trained staff of pharmacists and technicians. We compound a significant volume of medications, including intravenous (IV) bags, hormone injections, ophthalmic solutions, and other complex formulations. These medications are distributed to hospitals, clinics, and physician offices to support their patient treatment protocols. Our commitment is to ensure that every preparation leaving our facility is safe, effective, and reliable.
For healthcare providers and facilities seeking a trusted source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to excellence and patient safety. We operate with a focus on integrity, precision, and compliance, providing a vital service to the medical community. To learn more about our services or to discuss your facility's needs, you can reach us at our website, , or by phone at (407)993-1381.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
Being an FDA-registered outsourcing facility means our operations at 2160 W State Road 434, Longwood, FL 32779 are subject to current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures the medications we compound meet the highest federal standards for sterility, potency, and purity, providing an extra layer of safety and quality assurance for healthcare providers and their patients.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy 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 our location on 2160 W State Road 434, Longwood, FL 32779. All orders must be placed by a licensed medical professional.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable medications, including IV solutions, epidurals, and hormone therapy injections. We also compound non-sterile preparations. Our focus is on medications that are on the FDA's drug shortage list or are not otherwise commercially available from large pharmaceutical manufacturers.
4. How does the quality control process work at your facility?
At our location on 2160 W State Road 434, Longwood, FL 32779, every batch of compounded medication undergoes rigorous quality control testing. This includes analytical testing to verify potency and purity, sterility testing, and endotoxin testing. Our processes are strictly documented and validated in full compliance with FDA cGMP requirements to ensure product consistency and safety.
5. How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities and providers interested in our services can initiate the process by contacting our team directly. You can reach us by phone at (407)993-1381 to speak with a representative about your specific needs, our available formulations, and the ordering protocol. Our website, , also provides information for potential clients.