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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are located at 2160 W State Road 434, Longwood, FL 32779, providing essential pharmaceutical compounding services from this specific facility. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing large batches of compounded sterile and non-sterile medications for office use by healthcare practitioners. Our mission is to support the local medical community by providing a reliable, compliant source of high-quality medications that are not commercially available.
The operations at our 503B Compounding Pharmacy at 2160 W State Road 434 are strictly regulated. We follow current Good Manufacturing Practices (cGMP) as mandated by the FDA, ensuring every preparation meets stringent standards for potency, purity, and sterility. This level of oversight provides healthcare providers at our location with the confidence that the medications they utilize are produced under a robust quality system. Our dedicated team of pharmacists and technicians is committed to excellence in every aspect of the compounding process, from sourcing quality ingredients to meticulous preparation and testing.
Our facility at 2160 W State Road 434, Longwood, FL 32779, specializes in providing medications for office-use by physicians and practitioners. This service is a cornerstone of our operation, enabling healthcare providers to have the necessary medications on hand for immediate administration to their patients during procedures, treatments, or appointments. By supplying these medications from our 503B outsourcing facility, we help ensure practitioners have access to consistent, high-quality preparations, supporting efficient and effective patient care directly from their practice.
We understand the critical role a 503B Compounding Pharmacy plays in the healthcare ecosystem. The team at our Longwood location is focused on building strong, collaborative relationships with the medical professionals we serve. We prioritize clear communication, reliable service, and a steadfast commitment to compliance. For more information about our services or to discuss your specific needs, please contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our facility is ready to serve the healthcare community from our location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434 is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. This registration requires us to comply with rigorous federal standards, including current Good Manufacturing Practices (cGMP), for the production of compounded medications intended for office use by healthcare practitioners.
Who can receive medications from your 503B Compounding Pharmacy?
Our 503B Compounding Pharmacy provides medications for office-use to healthcare practitioners with prescribing authority. These medications are administered to patients within the practitioner's facility located at 2160 W State Road 434, Longwood, FL 32779. We do not provide medications directly to individual patients.
What types of medications does your facility at 2160 W State Road 434 prepare?
As a 503B outsourcing facility, we compound a range of sterile and non-sterile medications that are not available off-the-shelf from commercial manufacturers. This includes preparations for pain management, ophthalmology, dermatology, and other therapeutic areas, all produced in accordance with strict FDA cGMP regulations.
How does the quality control process work at your 503B facility?
Quality control is paramount. At our location, we implement a comprehensive quality program that includes testing raw materials, in-process testing, and finished preparation testing. Our adherence to cGMP standards ensures the identity, strength, quality, and purity of all medications we compound at 2160 W State Road 434.
How can a healthcare provider at this location place an order?
Healthcare practitioners can contact our 503B Compounding Pharmacy directly to establish an account and discuss their specific medication needs. Orders can be placed by calling our facility at (407)993-1381. Our team will guide you through the process and ensure your order is prepared and delivered efficiently from our location.