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 a specialized pharmacy located at 2160 W State Road 434, Longwood, FL 32779, dedicated to the large-scale, non-patient-specific compounding of sterile and non-sterile medications. Our core mission is to provide healthcare facilities and practitioners with access to high-quality, bulk-compounded preparations that are essential for patient care but may be commercially unavailable or in short supply.
As a 503B outsourcing facility, we adhere to the most stringent federal quality and safety standards, which are distinct from those of traditional compounding pharmacies. Our operations at 2160 W State Road 434, Longwood, FL 32779 are subject to current Good Manufacturing Practices (cGMP), and we undergo regular, rigorous FDA inspections. This ensures that every preparation leaving our facility meets exacting specifications for potency, purity, and sterility. Our commitment to cGMP provides an additional layer of assurance for the healthcare providers we serve.
The services provided by 503B Compounding Pharmacy at our location on W State Road 434 are specifically designed for healthcare professionals and facilities. We compound a significant volume of medications, including IV bags, epidurals, ophthalmics, and other injectables, which are critical for hospitals, surgery centers, clinics, and physician offices. By outsourcing their compounding needs to our 503B facility, healthcare providers can reallocate valuable resources, mitigate the risks associated with in-house compounding, and ensure their patients receive medications produced under the highest regulatory oversight.
Our team of highly skilled pharmacists and technicians at 2160 W State Road 434, Longwood, FL 32779 utilizes state-of-the-art technology and equipment within our controlled environment to ensure precision and consistency in every batch. We maintain a robust quality control department that performs extensive testing to validate our processes and final products. For healthcare providers seeking a reliable source for compounded medications, 503B Compounding Pharmacy stands as a trusted partner dedicated to supporting the local medical community with uncompromising quality and service.
To learn more about our services or to place an order, you can contact 503B Compounding Pharmacy directly. Reach us by phone at (407)993-1381 or visit our website at . Our facility is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
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 compound large quantities of sterile and non-sterile medications without patient-specific prescriptions and are required to comply with current Good Manufacturing Practices (cGMP) for superior quality control and safety.
2. Who can order medications from your 503B facility?
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare professionals and facilities. This includes hospitals, ambulatory surgery centers, clinics, and physician practices. We do not dispense medications directly to individual patients.
3. What types of medications do you compound at your location?
At our facility on W State Road 434, we specialize in compounding a wide array of sterile preparations, including intravenous (IV) bags, epidural injections, ophthalmic solutions, and other injectable medications that are often on drug shortage lists or are not available from commercial manufacturers.
4. How does your 503B status benefit our healthcare facility?
By ordering from our FDA-registered 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, your facility can reduce the operational burden and potential liability of in-house compounding. You receive medications produced under strict cGMP standards, which include rigorous testing for sterility, potency, and endotoxins.
5. How can I place an order or get more information?
You can contact 503B Compounding Pharmacy directly by calling (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is available to discuss your needs, provide a list of available medications, and assist with the ordering process.