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 federal oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures every preparation leaving our facility meets stringent potency, purity, and sterility requirements.
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. Our primary mission is to provide healthcare providers with access to essential medications that may be in shortage or are not commercially available. We serve as a critical partner to hospitals, clinics, and healthcare practitioners by supplying them with high-quality, batch-produced medications they can trust for their patients. Our operations are designed for efficiency and scale, enabling us to support the local medical community with reliable access to vital drugs.
The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists, pharmacy technicians, and quality assurance professionals. Every step of our process, from sourcing active pharmaceutical ingredients (APIs) from approved suppliers to the final packaging and labeling, is meticulously controlled and documented. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 features advanced environmental controls and isolator technology to ensure an aseptic compounding environment. This unwavering dedication to quality control and regulatory compliance is the foundation of our service.
We invite healthcare entities to partner with us for their pharmaceutical needs. For more information or to discuss how we can support your practice, 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 you from our facility at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stricter federal standards, including current Good Manufacturing Practices (cGMP). This ensures the medications we produce undergo rigorous testing for potency, sterility, and purity.
2. Who can place orders with 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to licensed healthcare practitioners and healthcare facilities. Orders are placed by medical professionals for administration to their patients under their care. We do not dispense medications directly to individual patients at our location on 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does this location compound?
Our FDA-registered facility at 2160 W State Road 434, Longwood, FL 32779 specializes in producing both sterile and non-sterile compounded medications in larger batches. This often includes medications that are currently in drug shortage or are not available from commercial manufacturers, providing a critical supply for area healthcare providers.
4. How does the quality assurance process work at this facility?
Our quality assurance process at 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It includes stringent testing of all incoming ingredients, environmental monitoring of our cleanrooms, and validated processes for sterilization and compounding. Finished products are tested to verify identity, strength, quality, and purity before being released.
5. How can a healthcare provider start ordering from 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. Please call us at (407)993-1381 to speak with a representative. We will guide you through the required documentation and set-up process to begin fulfilling orders from 2160 W State Road 434, Longwood, FL 32779.