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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, undergoing rigorous FDA inspections and producing medications in larger batches for office use by healthcare practitioners. This model allows us to provide physicians, surgeons, hospitals, and clinics with access to critical medications that are often in short supply or unavailable from conventional manufacturers.
The core function of 503B Compounding Pharmacy is to support the local medical community by delivering high-quality, compounded pharmaceutical products. Our state-of-the-art facility on W State Road 434 is designed with a focus on sterility and precision. We utilize advanced technology and stringent environmental controls to ensure every preparation meets exacting specifications for purity, potency, and safety. The medications produced are intended for office use, enabling healthcare providers at their practices to have essential drugs readily available for patient care without the delays associated with traditional pharmacy dispensing.
By choosing 503B Compounding Pharmacy at 2160 W State Road 434, healthcare professionals are partnering with a reliable source for compounded medications. Our commitment is to the consistent production of pharmaceuticals that healthcare providers can trust implicitly for their patients in Longwood. We provide a vital service to the local medical ecosystem, ensuring that practitioners have the necessary tools to deliver effective and immediate treatment.
For more information about our services or to speak with our team, please contact us. Website: | Phone: (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is focused on serving the compounding needs of the local healthcare community.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires compliance with Current Good Manufacturing Practices (cGMP) for higher standards of quality control, testing, and reporting compared to a traditional 503A pharmacy.
Who can order medications from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434 are designed for healthcare practitioners. Medications are prepared for office use and can be ordered by physicians, surgeons, clinics, and hospitals for administration to patients within their practice settings in Longwood.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in compounding both sterile and non-sterile medications that are often on drug shortage lists or are not commercially available. This includes injectables, ophthalmics, and other preparations essential for various medical treatments and procedures.
How does the quality assurance process work at your facility?
Our compounding processes at 2160 W State Road 434 are governed by strict cGMP protocols. This includes rigorous testing of components, in-process testing, sterility testing, and stability testing to ensure the identity, potency, purity, and quality of every batch of medication we produce.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers serving patients in Longwood can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach our facility at 2160 W State Road 434 by phone at (407)993-1381 or through our website at .