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 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 specifically designed and regulated to produce large quantities of compounded medications for office use. This means we provide healthcare practitioners with access to high-quality, sterile and non-sterile compounded preparations that are not commercially available, enabling them to better serve their patients.
The 503B outsourcing facility designation signifies that our operations, processes, and testing procedures meet the highest federal standards for quality, safety, and consistency. Unlike traditional 503A compounding pharmacies, a 503B Compounding Pharmacy like ours is subject to Current Good Manufacturing Practices (cGMP), which are the same rigorous standards required of major pharmaceutical manufacturers. This includes extensive environmental monitoring, stringent quality control testing on raw materials and finished preparations, and comprehensive documentation for full traceability of every product we compound.
Our primary service at 2160 W State Road 434, Longwood, FL 32779 is the large-scale compounding of medications for physician offices, hospitals, and healthcare clinics. We provide healthcare professionals with a reliable source for essential medications, including sterile injectables, ophthalmics, and other preparations that are often in short supply or discontinued by large manufacturers. By ensuring a consistent supply of these critical drugs, we support the local medical community in delivering continuous and effective patient care.
The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists and technicians who are experts in the science of compounding. Every preparation is executed with precision, utilizing state-of-the-art equipment within our controlled environment to ensure every vial, syringe, or bottle meets exact specifications. Our commitment is to provide the medical professionals we serve with uncompromising quality and reliability in every compounded preparation that leaves our facility.
For more information about the services provided by our 503B outsourcing facility, you can visit our website at or contact us directly by phone at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We compound large batches of medications for office use by healthcare practitioners and must adhere to strict Current Good Manufacturing Practices (cGMP) for quality and safety.
Who can order compounded medications from this 503B Compounding Pharmacy?
Our services are designed for healthcare practitioners and institutions. Licensed physicians, clinics, and hospitals can order compounded preparations from our facility at 2160 W State Road 434, Longwood, FL 32779 for office use in treating their patients.
Can individual patients pick up prescriptions directly from your location?
No. As a 503B outsourcing facility, we provide medications for office use to healthcare providers. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. Patients should receive their medications directly from their healthcare provider.
What types of medications does this 503B Compounding Pharmacy prepare?
We compound a range of sterile and non-sterile preparations, including injectables, ophthalmics, and other solutions that are often on drug shortage lists or are not commercially available. All preparations are made at our facility on 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance at a 503B outsourcing facility differ?
Our 503B Compounding Pharmacy operates under cGMP standards, which mandate rigorous testing of ingredients, validation of sterilization processes, and environmental monitoring to ensure every batch of medication is pure, potent, and sterile before it is released for distribution.