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 compliance in the preparation of compounded medications. We serve healthcare providers and patients by producing large-scale compounded sterile preparations (CSPs) and compounded non-sterile preparations that are essential for patient-specific therapeutic needs.
As a 503B outsourcing facility, our operations are distinct from traditional compounding pharmacies. We undergo rigorous FDA inspections and adhere to Current Good Manufacturing Practices (cGMP), ensuring that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent federal quality standards. This provides an additional layer of safety and reliability for the medications we compound. Our primary focus is on producing medications for office use, allowing healthcare practitioners in our community to have vital medications readily available for their patients without the delay of patient-specific compounding.
The services provided by 503B Compounding Pharmacy at our Longwood location are critical for supporting local medical practices, hospitals, and clinics. We compound a significant volume of medications, including sterile injectables, ophthalmics, and other formulations that are often in short supply from conventional manufacturers. By operating from our facility at 2160 W State Road 434, we are able to provide a consistent and dependable source of these essential medications, helping to mitigate drug shortages and ensure continuity of ca