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 as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency 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 provides medications for office use by healthcare practitioners.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. These medications are produced in bulk for healthcare providers, hospitals, and clinics, without receiving patient-specific prescriptions. Our operations at 2160 W State Road 434, Longwood, FL 32779 are designed to support the local medical community by providing them with a reliable, high-quality source for essential medications that may be in shortage or are not commercially available. We utilize state-of-the-art technology and controlled environments to ensure every preparation meets exacting specifications for purity, potency, and sterility.
By choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, healthcare professionals can be confident they are sourcing medications from a facility that prioritizes patient safety above all else. Our processes are continuously monitored and validated, and our products are accompanied by certificates of analysis. We serve as a critical partner to practitioners, enabling them to access necessary medications for their practice needs with the assurance of federal compliance and quality assurance. For more information or to discuss your facility's needs, please contact us via our website or phone number.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We compound medications in large volumes for office use by healthcare practitioners and must adhere to strict current Good Manufacturing Practice (cGMP) regulations, which are more rigorous than the standards applied to traditional compounding pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare practitioners, physicians, and medical facilities. We provide compounded medications for office use and do not accept orders directly from individual patients without a prescription from their provider.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in producing both sterile and non-sterile compounded preparations in bulk quantities. This includes medications that are on the FDA drug shortage list or those not readily available from commercial manufacturers, all produced at our facility on 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication quality and safety?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under cGMP guidelines. This involves stringent environmental controls, validated processes, extensive testing of components and finished products, and comprehensive documentation for every batch produced to ensure purity, sterility, and potency.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. Please reach out to us via phone at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/ to speak with a representative about your specific needs.