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 consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring that every preparation leaving our facility meets stringent federal quality standards.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. These medications are produced in bulk for office use by healthcare providers, meaning they are available for physicians to administer to patients directly within their practice at 2160 W State Road 434, Longwood, FL 32779. This model is essential for supporting local clinics, surgical centers, and specialist offices by providing them with a reliable, high-quality source of medications that may be commercially unavailable or in short supply. Our work is foundational to the local healthcare ecosystem, enabling practitioners to offer critical treatments without the burden of in-house compounding.
Our state-of-the-art facility at 2160 W State Road 434 is designed to prevent contamination. We utilize advanced environmental control systems, including ISO-classified cleanrooms, to ensure the sterility and potency of our preparations. Every batch is meticulously crafted by our team of expert pharmacists and technicians, and undergoes extensive testing and validation processes. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this translates to absolute confidence in the medications they use to treat their patients. We provide a vital service by compounding medications that are often on national drug shortage lists, ensuring continuity of care for patients in our immediate area.
503B Compounding Pharmacy is dedicated to serving the specific needs of the medical community operating from and around our location. We are a pivotal partner for physicians, offering a portfolio of essential preparations. Our operational model is focused on wholesale distribution to healthcare practitioners for office stock, not direct dispensing to individual patients. By centralizing the compounding process at our FDA-registered facility at 2160 W State Road 434, Longwood, FL 32779, we enhance patient safety, improve efficiency for local doctors, and uphold the most rigorous quality controls in the industry.
To learn more about our services or to speak with our team, we encourage healthcare providers to contact us directly. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
FAQ
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 Current Good Manufacturing Practices (cGMP) and undergo regular FDA inspections, ensuring a higher level of oversight and quality control for the compounded medications we produce.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy functions as a wholesale manufacturer. We produce large batches of medications for office use by healthcare providers. Individual patients do not obtain prescriptions directly from our facility at 2160 W State Road 434, Longwood, FL 32779. Your physician would administer any medication we compound directly in their office.
3. What types of medications does 503B Compounding Pharmacy produce?
We specialize in producing compounded sterile preparations, including injectables, IV bags, ophthalmics, and other medications that must be sterile. We also compound non-sterile preparations. These are primarily supplied to healthcare practices located at 2160 W State Road 434, Longwood, FL 32779 to be used as office stock for procedures and treatments.
4. How does your service benefit local doctors and clinics?
We provide local healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with immediate access to high-quality, reliable compounded medications that are often on national shortage lists. This allows them to maintain their inventory and perform essential treatments without delay, enhancing patient care and practice efficiency.
5. How can a healthcare provider at this location place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. Our team will provide all necessary information regarding ordering procedures, available formulations, and delivery options to 2160 W State Road 434, Longwood, FL 32779.