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 large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest standards of pharmaceutical quality, undergoing rigorous federal oversight to ensure every preparation meets specific strength, quality, and purity standards. We serve a critical role in the healthcare ecosystem by providing bulk compounded medications for physician offices, hospitals, and healthcare providers, helping to alleviate drug shortages and supply essential treatments that are not otherwise commercially available.
The core of our operation at 2160 W State Road 434, Longwood, FL 32779 is the production of medications in a state-of-the-art cleanroom environment. Our highly trained pharmacists and technicians utilize advanced technology and precise processes to compound formulations that are tailored for specific patient populations. This includes sterile injectables, ophthalmics, and other complex preparations that are essential for various medical treatments. By operating as a 503B outsourcing facility, we ensure a level of consistency, sterility assurance, and quality control that is paramount for patient safety and therapeutic efficacy.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a hub for reliable pharmaceutical sourcing. We provide healthcare professionals with access to a consistent supply of high-quality compounded medications, which is crucial for the continuity of patient care. The operations at this facility are designed to support the local medical community with efficiency and reliability. For more detailed information about our services and compliance, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact our facility directly at (407)993-1381 to speak with a representative.
Frequently Asked Questions
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 complies with strict federal current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet heightened standards for quality, purity, and sterility.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare providers and institutions. Orders are placed by physicians, hospitals, clinics, and other healthcare entities for administration to their patients under professional care.
Can I as an individual patient pick up a prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare providers, not as a retail pharmacy. Individual patient prescriptions are dispensed through the ordering healthcare provider or institution, not directly from our facility.
What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile injectable medications, including IV bags, ophthalmics, and other preparations that are often in short supply or unavailable from traditional pharmaceutical manufacturers.
How do I contact 503B Compounding Pharmacy for more information?
You can learn more about our services by visiting our website at https://503bcompoundingpharmacy.com/. For specific inquiries, healthcare providers can contact our facility directly at (407)993-1381.