Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
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 producing compounded medications under the highest standards of quality, safety, and sterility, as mandated by federal law. Unlike traditional compounding pharmacies, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring every preparation meets exacting specifications for the medical facilities we serve.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale compounding of sterile and non-sterile medications for office use. We provide these preparations to healthcare practitioners and facilities, enabling them to have essential medications readily available for patient administration. Our services are pivotal for hospitals, clinics, surgical centers, and other healthcare providers in need of a reliable, quality-focused source for compounded preparations. By operating as a 503B outsourcing facility, we provide a critical component of the healthcare supply chain, offering medications that are often in short supply or not available from conventional pharmaceutical manufacturers.
Our state-of-the-art facility at 2160 W State Road 434 is designed to prevent contamination, with controlled environments and advanced equipment. Every batch is compounded by our highly trained staff and undergoes stringent testing to verify potency, sterility, and purity. This meticulous process provides healthcare professionals with the confidence that the medications they use in their practice are safe, effective, and reliable. The team at 503B Compounding Pharmacy is dedicated to upholding the integrity of the pharmaceutical supply chain from our location in Longwood, FL.
For healthcare entities seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy stands as a pillar of quality and compliance. We invite medical professionals to learn more about our specific services and capabilities. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. 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 requires us to comply with stringent federal standards, including Current Good Manufacturing Practices (cGMP), and subjects us to regular FDA inspections to ensure the quality, safety, and sterility of our compounded preparations.
2. Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides compounded medications for office use by healthcare practitioners and facilities. Our preparations are supplied to hospitals, clinics, surgical centers, and other healthcare providers located within our service area for administration to their patients within a professional practice setting.
3. What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications in larger batches. This includes preparations like sterile injectables, ophthalmics, and other formulations that are often on drug shortage lists or are needed by healthcare providers in bulk for their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How does 503B Compounding Pharmacy ensure medication quality?
Quality is assured through strict adherence to cGMP guidelines. Our processes include environmental monitoring, validated sterilization techniques, and rigorous analytical testing for potency, sterility, and endotoxins. Every batch is produced and tested within our facility to meet the highest pharmaceutical standards before being released.
5. How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities and practitioners can contact 503B Compounding Pharmacy directly to discuss their specific needs and place an order. You can reach our team by calling (407)993-1381. Additional information about our services and capabilities is available on our website at https://503bcompoundingpharmacy.com/.