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 dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, sterility testing, and production processes, providing a critical component of the pharmaceutical supply chain for healthcare providers.
As a 503B outsourcing facility, our primary function is to support the medical community by producing medications that are patient-specific but are compounded in larger batches before receiving individual prescriptions. This model allows us to ensure consistent quality and availability of essential drugs that may be in shortage or are not commercially available. The medications prepared at our Longwood location are distributed to healthcare facilities for office use and are not typically dispensed directly to the public from our facility. Our operations are pivotal in helping to mitigate drug shortages and provide practitioners with the necessary tools for patient care.
The team at our 2160 W State Road 434 facility comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals. Every step of our compounding process, from ingredient sourcing to final packaging, is governed by rigorous standard operating procedures and current good manufacturing practices (cGMP). This ensures that every preparation leaving our pharmacy meets precise sterility, potency, and purity specifications. We are committed to upholding the trust placed in us by the healthcare professionals we serve.
For inquiries regarding our services and capabilities, please contact us via our website at or by phone at (407)993-1381. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to excellence in pharmaceutical compounding.
FAQ
What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stringent federal standards for compounding medications in larger volumes for office use by healthcare practitioners, distinct from traditional retail compounding.
Can I, as a patient, pick up a prescription directly from your location?
No, 503B Compounding Pharmacy primarily supplies medications to healthcare facilities and practitioners for office use. Patients should receive their medications directly from their doctor's office or a dispensing pharmacy.
What types of medications do you compound at your Longwood facility?
Our FDA-registered facility at 2160 W State Road 434 specializes in compounding sterile injectables, ophthalmics, and other preparations that are often on drug shortage lists or are not available from commercial manufacturers.
How do I place an order for my practice?
Healthcare providers and facilities can place orders by contacting our facility directly at (407)993-1381. Our team will guide you through the ordering process specific to our 503B outsourcing services.
How does your location ensure the quality of its compounded preparations?
Our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to current good manufacturing practices (cGMP) and conducts rigorous sterility, potency, and endotoxin testing on our products to ensure they meet all quality and safety specifications.