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 at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under 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. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP). This designation distinguishes our operations from traditional compounding pharmacies and ensures that healthcare providers at our location receive medications that are consistently produced and rigorously controlled according to stringent quality standards.
The services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are primarily focused on supplying medications to healthcare facilities and practitioners for office use. We compound a significant volume of medications that are essential for patient care, including sterile injectables, ophthalmics, and other formulations that may be in shortage or not commercially available. Our role is to support the medical community by providing a reliable source of high-quality compounded preparations, thereby enhancing patient safety and treatment outcomes for those receiving care from providers who utilize our services.
Patients and healthcare professionals visiting or contacting 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be assured of our commitment to compliance and excellence. Our processes are designed to mitigate the risks of contamination and ensure potency and stability. We welcome inquiries from healthcare providers seeking a dependable source for compounded medications for their practice. For more information about the specific preparations available, please contact us directly at our facility. You can reach us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this facility is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound are produced with a higher level of quality control and consistency for healthcare providers.
2. Can I, as a patient, walk into the 503B Compounding Pharmacy location to get a prescription filled?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates as an outsourcing facility that primarily supplies compounded medications in bulk for "office use" by healthcare practitioners. We do not typically dispense medications directly to individual patients based on a personal prescription.
3. What types of medications does 503B Compounding Pharmacy compound?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile preparations, including injectables, IV bags, and ophthalmics. We focus on medications that are on shortage or are not available from commercial manufacturers, providing them for healthcare settings.
4. How can a healthcare provider at your location order compounded medications?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at our location. We can be reached by phone at (407)993-1381 to discuss specific medication needs, availability, and the ordering process for our office-use compounded preparations.
5. Why should a medical practice at 2160 W State Road 434 use a 503B outsourcing facility?
Utilizing a 503B outsourcing facility like ours provides assurance of quality and compliance. The medications supplied from our location are produced under cGMP standards, which rigorously test for sterility, potency, and purity, offering a critical layer of safety for patients and reliability for practitioners.