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, producing medications in larger batches for office use by healthcare practitioners or for distribution to other pharmacies and healthcare entities without patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, compounded medications that are essential for patient care. Our services at the 2160 W State Road 434 location are distinct from traditional compounding pharmacies, as we operate on a larger scale under current Good Manufacturing Practices (cGMP). This ensures every preparation undergoes rigorous testing and quality control procedures, providing practitioners with a reliable and trusted source for medications that may be in shortage or not commercially available.
Our team at the Longwood facility comprises highly skilled pharmacists and technicians who are experts in advanced compounding techniques. We utilize state-of-the-art equipment and technology within our controlled environment to ensure the integrity, potency, and sterility of every preparation that leaves our facility. The 503B Compounding Pharmacy is committed to supporting the local medical community by providing a critical service that helps ensure patients receive the necessary medications for their treatment plans.
For healthcare providers seeking a dependable source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and reliability. We invite you to contact us to learn more about our available preparations and how we can support your practice. You can reach us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
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 FDA and regulated under Section 503B of the FD&C Act. We comply with more stringent production standards, including current Good Manufacturing Practices (cGMP), and we are subject to regular FDA inspections to ensure the quality and safety of our preparations.
Can I, as an individual patient, pick up a prescription directly from your location?
No, 503B Compounding Pharmacy primarily supplies medications for office use by healthcare practitioners or to other pharmacies. Patients should work directly with their healthcare provider, who can order the necessary medications from our facility at 2160 W State Road 434, Longwood, FL 32779 for administration in a clinical setting.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in preparing a range of sterile and non-sterile compounded medications, often including formulations that are on drug shortage lists or are not available from conventional manufacturers. Healthcare providers can contact us at (407)993-1381 to inquire about specific preparations available from our Longwood location.
How does a healthcare provider place an order with your facility?
Healthcare providers and other eligible entities can place orders by contacting 503B Compounding Pharmacy directly. Our team at 2160 W State Road 434, Longwood, FL 32779 will provide ordering information, including our available product list and terms. You can initiate this process by calling (407)993-1381.
Why would a healthcare provider choose a 503B outsourcing facility over a traditional 503A pharmacy?
Healthcare providers choose a 503B outsourcing facility like ours for medications intended for office use because our preparations are made under cGMP standards, which involve batch-level quality control testing and reporting of adverse events. This provides an additional layer of safety and assurance for medications administered to patients within their practice at 2160 W State Road 434, Longwood, FL 32779.