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. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing compounded medications in large batches for office use by healthcare practitioners. Our primary mission is to provide physicians, hospitals, and clinics with access to sterile and non-sterile compounded preparations that are not commercially available, ensuring patient-specific needs are met with precision and care.
Our facility at 2160 W State Road 434 is specifically designed and equipped to meet the rigorous cGMP (current Good Manufacturing Practice) standards set forth by the FDA. This ensures that every preparation leaving our pharmacy is of the highest quality, purity, and potency. We specialize in the compounding of medications that are often in short supply or discontinued by major manufacturers, providing a critical service to the medical community. Our team of highly trained pharmacists and technicians utilizes state-of-the-art technology and rigorous testing protocols, including sterility testing and endotoxin testing, to guarantee the integrity of our products.
We serve healthcare providers who require reliable, high-quality compounded pharmaceuticals for their practice. Our location at 2160 W State Road 434, Longwood, FL 32779, allows us to efficiently serve the local medical community. We compound a wide array of preparations, including sterile injectables, hormone replacement therapies, ophthalmic solutions, and other essential medications. By operating as a 503B outsourcing facility, we provide practitioners with the assurance that our processes are consistently monitored and validated, offering a level of quality control that goes beyond traditional compounding.
For healthcare professionals seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy at 2160 W State Road 434 is the definitive choice. We are committed to excellence, safety, and reliability in every preparation. To learn more about our services or to place an order, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
Being a 503B outsourcing facility means we are registered with the FDA and strictly adhere to current Good Manufacturing Practices (cGMP). This regulatory status signifies we operate under heightened quality control standards for the large-scale compounding of medications intended for office use by healthcare practitioners.
2. Who can place orders with your pharmacy at 2160 W State Road 434?
Our services are designed for healthcare providers. Orders can be placed by physicians, hospitals, clinics, and other healthcare entities that require compounded medications for their patients. We work directly with medical professionals.
3. What types of medications do you compound at your Longwood location?
At our facility at 2160 W State Road 434, we compound a range of sterile and non-sterile preparations. This includes, but is not limited to, sterile injectables, hormone therapies, ophthalmic drops, and other solutions that are not available from commercial manufacturers.
4. How do you ensure the quality and sterility of your compounded preparations?
We enforce rigorous cGMP standards, which involve extensive environmental monitoring, validated cleaning procedures, and comprehensive testing of our finished preparations. This includes sterility testing, endotoxin testing, and potency assays to ensure every product meets strict quality specifications.
5. How can I contact your facility to place an order or ask a question?
You can reach our team at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. You can also visit our website at for more information and to initiate contact.