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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent federal quality standards for sterility, potency, and purity. We provide essential medications to healthcare providers for office use and to hospitals, ensuring they have access to critical drugs that are often in short supply or unavailable from conventional manufacturers.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale production of compounded sterile preparations (CSPs). Our operations are designed to support the local medical community by providing bulk quantities of high-quality medications. We utilize state-of-the-art technology and controlled environments to compound medications that are free from contamination. Our highly trained staff, including pharmacists and technicians, follows exacting protocols to ensure every batch is accurately prepared and thoroughly tested. By focusing on non-patient-specific, office-use medications, we serve as a vital resource for physicians, clinics, and surgical centers in the area, enabling them to better serve their patients with reliable and necessary pharmaceutical products.
Our facility at 2160 W State Road 434 is equipped to handle a significant volume of orders while maintaining an unwavering focus on quality control. We maintain a robust quality management system that oversees every aspect of the compounding process, from ingredient sourcing to final product release. All components are carefully vetted, and finished products undergo analytical testing to verify identity, strength, and sterility. This meticulous approach minimizes risk and provides healthcare professionals with the confidence that the medications they administer are safe and effective. 503B Compounding Pharmacy is dedicated to upholding the trust placed in us by the medical community at our Longwood location.
For more information about our services or to place an order, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at . Our team is ready to assist healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with their compounding needs.
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 U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring a higher level of quality and safety control for the compounded medications we produce.
Who can order medications from 503B Compounding Pharmacy?
Our medications are produced for office use and are distributed to healthcare practitioners and facilities. Orders are placed by physicians, clinics, hospitals, and other healthcare providers. We do not fulfill prescriptions for individual patients directly; we supply medications in bulk to medical professionals for administration within their practice.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
We specialize in compounding sterile preparations (CSPs). This includes injectable medications, IV bags, ophthalmics, and other sterile products that are often on drug shortage lists or are needed by healthcare providers in specific strengths or formulations not commercially available from large pharmaceutical manufacturers.
How does the quality control process work at your facility?
Our quality control process at 2160 W State Road 434 is comprehensive. It involves rigorous testing of raw materials, environmental monitoring of our cleanrooms, and validated processes for sterilization and compounding. Finished products undergo testing for sterility, potency, and endotoxins before they are released for distribution, ensuring they meet all specified quality attributes.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly. Please call us at (407)993-1381 to speak with a representative. You can also visit our website at for more information on our available products and ordering procedures.