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. This designation is central to the operations at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are distinct from traditional compounding pharmacies. Our facility is subject to current Good Manufacturing Practices (cGMP), which are the same rigorous standards applied to conventional drug manufacturers. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets the highest possible standards for sterility, purity, and potency. Our primary mission is to provide healthcare facilities with bulk quantities of compounded sterile preparations (CSPs) that are safe, reliable, and consistent.
The services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are designed to support hospitals, clinics, surgical centers, and other healthcare providers. We compound large batches of medications, such as IV bags, epidurals, and ophthalmics, which are then administered to patients within a healthcare setting. The 503B model allows us to produce these medications proactively, based on historical need, rather than waiting for individual patient-specific prescriptions. This operational efficiency is a key benefit for the healthcare institutions we serve from our location at 2160 W State Road 434, Longwood, FL 32779, helping to ensure critical medications are available when needed and reducing the burden on their internal pharmacies.
Quality control is the foundation of everything we do at 503B Compounding Pharmacy. Our facility at 2160 W State Road 434, Longwood, FL 32779 employs a team of highly trained pharmacists and technicians who work within a controlled environment. Our cleanrooms are meticulously maintained and monitored to exceed sterility assurance levels. Every batch of medication is rigorously tested for sterility and endotoxins, and our processes are thoroughly documented to provide full traceability. This unwavering commitment to quality, inherent to our 503B status, provides healthcare professionals with the confidence that the medications they use from our facility are of the utmost quality and safety.
Engaging with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a straightforward process for healthcare facilities. Our team works directly with healthcare providers to understand their specific formulary needs and medication usage patterns. We encourage potential clients to visit our website or contact us directly to initiate a conversation about how our 503B compounding services can integrate into their supply chain and enhance patient care protocols. The professionals at our location are ready to discuss your facility's requirements.
For more information, or to discuss your facility's needs, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website for detailed information about our capabilities and compliance status at https://503bcompoundingpharmacy.com/. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to answer your questions and provide the high-quality, compounded medications your patients deserve.
Frequently Asked Questions for 503B Compounding Pharmacy
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 subjects us to stricter manufacturing standards, known as current Good Manufacturing Practices (cGMP), compared to a traditional 503A pharmacy.
2. Who can order medications from your facility at 2160 W State Road 434? 503B Compounding Pharmacy provides medications primarily to healthcare facilities and practitioners for office use. This includes hospitals, ambulatory surgical centers, clinics, and other healthcare institutions that administer medications within their practice. We do not typically serve individual patients directly from this location.
3. What types of medications does 503B Compounding Pharmacy prepare? As a 503B outsourcing facility, we specialize in producing large-scale batches of compounded sterile preparations (CSPs). This includes, but is not limited to, IV solutions, epidural injections, ophthalmic drops, and other injectable medications that are essential for healthcare facilities serving patients.
4. How does the quality assurance process work at your Longwood location? Our quality assurance at 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It involves environmental monitoring of our cleanrooms, rigorous testing of each batch for sterility and endotoxins, and strict adherence to standard operating procedures under cGMP. All processes are thoroughly documented to ensure full accountability and traceability.
5. How can a healthcare facility start ordering from 503B Compounding Pharmacy? Healthcare facilities interested in our services should contact us directly to establish an account. You can initiate this process by calling our facility at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ to learn more about our capabilities and to speak with a representative.