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 and safety, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving our facility meets stringent federal requirements for strength, quality, purity, and identity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. We provide these preparations to healthcare practitioners with prescriptive authority, enabling them to have essential medications readily available for their patients. The services at our location on 2160 W State Road 434, Longwood, FL 32779 are designed to support the local medical community by offering a reliable source of high-quality, compounded drugs that are not otherwise commercially available. This includes preparations where a commercial product has been discontinued or is experiencing a shortage, or when a specific strength or formulation is required for patient care that is not offered by a pharmaceutical manufacturer.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists and technicians. Every batch of medication is compounded in a controlled environment and undergoes rigorous testing to ensure its integrity and sterility. The 503B Compounding Pharmacy model provides healthcare professionals with the assurance that the medications they administer or dispense to their patients are produced under the most exacting quality controls. For more information or to discuss your office use needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. 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. We are subject to federal oversight and must comply with Current Good Manufacturing Practices (cGMP), which involve rigorous standards for production, testing, quality control, and sterility assurance.
2. Can I, as a patient, order medications directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide compounded medications for office use to healthcare practitioners. Patients must receive these medications through their physician or another healthcare professional with prescriptive authority who has ordered from our facility at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our facility specializes in preparing sterile injectables, ophthalmics, and other medications that are in shortage or not available from commercial manufacturers. All preparations are made in batches for office use by healthcare providers and are produced according to the highest quality and sterility standards.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare practitioners with prescriptive authority can contact 503B Compounding Pharmacy directly to establish an account and discuss their office use needs. Orders can be placed by calling our facility at (407)993-1381. Our team will guide you through the process.
5. Why would a healthcare provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Healthcare providers choose a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 because of the enhanced federal oversight and mandatory compliance with cGMP regulations. This provides an additional layer of safety and quality assurance for medications used in their practice, particularly for sterile injectables.