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 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. Unlike traditional compounding pharmacies, our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), ensuring every preparation meets stringent federal guidelines for sterility, potency, and purity. We provide large-scale compounding services for healthcare providers, supplying medications for office use to support the patient care provided at 2160 W State Road 434, Longwood, FL 32779.
The core function of 503B Compounding Pharmacy is the non-patient-specific, large-volume production of compounded sterile preparations (CSPs). Our services are designed for physician offices, hospitals, clinics, and other healthcare entities that require readily available, high-quality medications for immediate administration to patients. By operating as a 503B outsourcing facility, we provide an essential layer of safety and reliability, offering healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 access to medications that are produced in a monitored environment with full accountability and lot-level quality control. This model allows practitioners to focus on patient care with confidence in the medications they use.
Quality assurance is the foundation of our operation at 2160 W State Road 434, Longwood, FL 32779. Our processes include extensive testing of components, in-process checks, and finished preparation testing. Our sterile compounding procedures are conducted by highly trained personnel in ISO-classified cleanrooms to prevent contamination. Every batch of medication is meticulously documented, creating a complete history from raw materials to the final product. This unwavering dedication to cGMP standards ensures that every preparation leaving our facility is of the highest possible quality and safety for the patients who will ultimately receive it.
503B Compounding Pharmacy serves a critical role in mitigating drug shortages and providing essential medications that may be commercially unavailable. Our capabilities include compounding a wide range of sterile preparations, such as injections, infusions, and ophthalmics, that are crucial for various medical treatments. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on us as a trusted partner for a consistent supply of vital medications, enabling them to maintain continuity of care for their patients without interruption.
For more information about our services or to discuss your facility's needs, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at . Our team is dedicated to supporting the medical community at 2160 W State Road 434, Longwood, FL 32779 with reliable, high-quality compounded medications.
FAQ
1. 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 operates under Section 503B of the FD&C Act. We comply with current good manufacturing practices (cGMP) for large-scale compounding, which involves stricter quality control, testing, and reporting standards compared to traditional pharmacies.
2. Can I, as an individual patient, get a prescription filled at your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. We supply medications directly to physicians, clinics, and hospitals at 2160 W State Road 434, Longwood, FL 32779 for them to administer to their patients within their practice. Patients must work with their healthcare provider to access our medications.
3. What kinds of medications do you compound at your facility?
We specialize in compounding sterile preparations (CSPs) such as injectables, infusions, and ophthalmics. These are prepared in large batches under cGMP standards to ensure sterility and potency for healthcare providers serving patients at 2160 W State Road 434, Longwood, FL 32779.
4. How does your service benefit healthcare providers at this location?
We provide a reliable, compliant source of high-quality compounded medications for office use. This helps providers at 2160 W State Road 434, Longwood, FL 32779 manage drug shortages, access medications not commercially available, and reduce the compounding burden on their own staff, all while ensuring patient safety through our rigorous quality controls.
5. How can a healthcare facility at this address place an order?
Healthcare providers and facilities at 2160 W State Road 434, Longwood, FL 32779 can contact us directly to establish an account and discuss their specific needs. You can reach our team by calling (407)993-1381 or by visiting our website at .