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 precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), ensuring that every batch of medication we produce meets stringent federal guidelines for strength, quality, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare providers. Our services are designed to supply physicians, clinics, hospitals, and other healthcare entities with essential medications that are not readily available from commercial manufacturers. By operating from our specific location at 2160 W State Road 434, Longwood, FL 32779, we provide a reliable, local source for critical drugs, including IV bags, injectables, and other sterile preparations. This supports the local medical community by ensuring patient access to necessary treatments while mitigating risks associated with drug shortages.
Our processes at the Longwood facility are built upon a foundation of precision and sterility. Every batch is compounded in our state-of-the-art cleanrooms by highly trained personnel utilizing advanced technology. This meticulous approach minimizes the potential for contamination and guarantees the consistency and reliability of every preparation that leaves our facility. We serve as a vital component of the healthcare infrastructure for providers who rely on our 503B compounding pharmacy services at 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy offers a dependable solution. To learn more about our services or to initiate an order, we encourage you to contact us directly. You can reach our team 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 specific 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 more rigorous federal standards, including current Good Manufacturing Practices (cGMP), which are typically applied to large-scale drug manufacturers, ensuring a higher level of quality control and sterility assurance for our compounded preparations.
2. Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications primarily to healthcare providers and facilities, not directly to individual patients. Physicians, surgeons, hospitals, and clinics within the local area can order compounded sterile preparations from our location at 2160 W State Road 434, Longwood, FL 32779 for administration to their patients under their professional supervision.
3. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in the large-scale compounding of sterile preparations. This includes, but is not limited to, intravenous (IV) bags, injectable medications, ophthalmics, and other solutions that require an aseptic compounding environment. Our focus is on providing medications that are on the FDA drug shortage list or are otherwise not available from conventional manufacturers.
4. How does 503B Compounding Pharmacy ensure the quality of its products?
Quality is ensured through strict adherence to cGMP guidelines at our facility on W State Road 434. This involves environmental monitoring of our ISO-classified cleanrooms, rigorous testing of components and finished products, validation of all processes and equipment, and comprehensive documentation. Every batch is produced under these controlled conditions to guarantee sterility, potency, and purity.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly to establish an account. Orders can be placed by calling our facility at (407)993-1381. Our team will guide you through the process, which includes the necessary documentation and protocols required for compounding and distribution from our location at 2160 W State Road 434, Longwood, FL 32779.