Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates from its facility at 2160 W State Road 434, Longwood, FL 32779 as an FDA-registered outsourcing facility. This designation, granted under Section 503B of the Federal Food, Drug, and Cosmetic Act, signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving the facility meets stringent quality control benchmarks for purity, potency, and sterility.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but not intended for individual prescriptions. The facility provides essential medications to healthcare providers, including hospitals, clinics, and physician practices, enabling them to have critical drugs readily available for patient care. The services at 2160 W State Road 434, Longwood, FL 32779 are designed to address specific needs, such as producing formulations that are commercially unavailable due to drug shortages or discontinuations. This vital service helps ensure continuity of care for patients who rely on these specific medications.
Operating from 2160 W State Road 434, Longwood, FL 32779, the pharmacy specializes in sterile injectable preparations. This complex process requires a controlled environment with advanced air filtration systems to ensure the sterility of parenteral medications. The team at 503B Compounding Pharmacy comprises highly trained pharmacists and technicians who are experts in aseptic technique and quality assurance. Every batch produced is meticulously documented and tested to provide healthcare professionals with complete confidence in the medications they administer to their patients.
503B Compounding Pharmacy is dedicated to serving the healthcare community by providing a reliable source of high-quality compounded medications. The focus remains on safety, compliance, and meeting the specific needs of practitioners. For more information about the services available from this location, or to discuss how 503B Compounding Pharmacy can support your practice, please make direct contact. The team can be reached by phone at (407)993-1381. Comprehensive details about the facility, its compliance standards, and its service offerings are available on the official website at https://503bcompoundingpharmacy.com/.
FAQ
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 operates under Section 503B of the FD&C Act. We are subject to federal oversight, including compliance with current Good Manufacturing Practices (cGMP) and routine FDA inspections, which ensures a higher level of quality control for our compounded medications compared to traditional pharmacies.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications to healthcare facilities and practitioners, such as hospitals, clinics, and doctor's offices. We do not compound medications for individual patients based on a direct prescription. Our services are designed to supply healthcare providers with batches of medications for office use or to address specific patient needs within their practice.
What types of medications does 503B Compounding Pharmacy specialize in?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in the compounding of sterile injectable medications. This includes a range of preparations that are essential for healthcare providers but may be experiencing a shortage on the commercial market or require a specific formulation not otherwise available.
How does 503B Compounding Pharmacy ensure the quality of its products?
Quality is ensured through strict adherence to cGMP regulations. This involves rigorous environmental controls, validated processes, comprehensive staff training, and extensive testing of components and finished preparations. Every batch produced at our Longwood facility is subject to these stringent quality assurance protocols.
How can a healthcare provider at 2160 W State Road 434 place an order with 503B Compounding Pharmacy?
Healthcare providers and facilities can initiate contact with 503B Compounding Pharmacy to discuss their needs and place orders. For detailed information and to begin the process, please call us directly at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to learn more about our services and compliance.