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 the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we produce large batches of compounded sterile preparations (CSPs) and non-sterile preparations for office use by healthcare practitioners. Our operations are distinct from traditional compounding pharmacies, as we are subject to rigorous FDA oversight, current Good Manufacturing Practices (cGMP), and mandatory reporting of adverse events.
The services provided by 503B Compounding Pharmacy at our Longwood location are specifically designed to support the practices of local healthcare providers. We supply physician offices, hospitals, and clinics with high-quality, ready-to-administer medications that are essential for patient treatment plans. Our portfolio includes a wide array of sterile preparations, such as injectables, IV bags, ophthalmics, and irrigation solutions, all produced in our state-of-the-art cleanroom facility. By outsourcing their compounding needs to our 503B facility, healthcare professionals at 2160 W State Road 434 can be assured of receiving medications that meet stringent federal quality standards, allowing them to focus their resources on direct patient care.
Our team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in sterile and non-sterile compounding techniques. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented to ensure product integrity and patient safety. We utilize advanced analytical testing to verify the potency, purity, and sterility of every batch we produce. For healthcare providers at our location, this translates to reliable access to essential medications they can trust, reducing the administrative and regulatory burdens associated with in-office compounding.
Healthcare providers seeking a dependable source for compounded medications are encouraged to contact 503B Compounding Pharmacy. We are ready to discuss your specific needs and how our 503B services can enhance your practice's efficiency and patient care standards. You can reach us by phone at (407)993-1381 to speak with a representative. For more detailed information about our capabilities and compliance standards, please visit our website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 and inspected by the U.S. Food and Drug Administration (FDA) under Section 503B of the FD&C Act. We operate under current Good Manufacturing Practices (cGMP), which are stricter standards than those applied to traditional compounding pharmacies, ensuring a higher level of quality control and consistency in the medications we produce.
Who can purchase medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our 503B outsourcing facility provides medications for office use by healthcare practitioners. Our primary customers are physicians, clinics, hospitals, and other healthcare entities that administer medications on-site at their practices. We do not dispense medications directly to individual patients from this location.
What types of medications does 503B Compounding Pharmacy produce?
We specialize in producing large batches of compounded sterile preparations (CSPs), including injectables, intravenous (IV) solutions, ophthalmics, and irrigation solutions. These are supplied to healthcare providers for use within their practices located at 2160 W State Road 434, Longwood, FL 32779.
How does using a 503B outsourcing facility benefit my practice?
Utilizing our services reduces the regulatory and quality control burdens on your practice. You can be confident that the medications you administer are produced under the highest federally mandated quality standards, which can mitigate risk, improve patient safety, and free up your staff to focus on clinical care rather than compounding.
How can I place an order or get more information for my practice?
You can contact 503B Compounding Pharmacy directly by calling (407)993-1381. Our team will assist you with setting up an account, discussing your medication needs, and answering any specific questions. You can also learn more about our processes and compliance by visiting our website at https://503bcompoundingpharmacy.com/.