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 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 control, undergoing rigorous FDA inspections and producing medications in larger batches for office use by healthcare practitioners. This model ensures that physicians, surgeons, and other medical professionals at local practices have immediate access to the critical medications they need for their patients.
The core function of 503B Compounding Pharmacy is to provide a reliable source of high-quality compounded pharmaceuticals. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by expert compounding pharmacists and technicians. We specialize in producing medications that are often on shortage or are not available from traditional manufacturers, ensuring continuity of care for patients. Every batch is tested for potency, sterility, and purity, providing unparalleled assurance for the medical community we serve directly from our Longwood facility.
Healthcare providers in need of compounded medications for their practice can rely on 503B Compounding Pharmacy. Our services are designed to support local clinics, hospitals, and surgical centers by providing them with essential drugs, including sterile injectables, ophthalmics, and other preparations. By operating as a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we fulfill a vital role in the healthcare ecosystem, enabling practitioners to obtain compounded medications without the need to hold large inventories, thus enhancing patient safety and treatment outcomes.
For more information about the services provided by 503B Compounding Pharmacy, please contact us directly. You can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or visit our website to learn more about our compliance and offerings at https://503bcompoundingpharmacy.com/.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific 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. This requires us to comply with Current Good Manufacturing Practices (cGMP) and undergo regular FDA inspections, ensuring the medications we compound meet the highest standards for strength, identity, quality, and purity.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Our services are designed for physicians, surgeons, and other medical professionals with practices that require access to compounded pharmaceuticals for patient care directly from our location at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a range of sterile and non-sterile medications, including injectables, ophthalmics, and other preparations that are often on national shortage or are not commercially available. All compounding activities are conducted exclusively at our facility on W State Road 434 in Longwood.
How does 503B Compounding Pharmacy ensure medication safety?
Safety is paramount at our Longwood facility. We enforce strict cGMP protocols, which include environmental monitoring, validated processes, and independent testing of every batch for sterility, potency, and endotoxins before release. This rigorous quality control is a fundamental requirement of our 503B status.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. All orders are prepared and shipped from our facility located at 2160 W State Road 434, Longwood, FL 32779.