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 is central to our operational philosophy, distinguishing our services from a traditional 503A compounding pharmacy. As a 503B outsourcing facility, we are held to rigorous federal standards for current good manufacturing practices (cGMP), which govern every aspect of our production, from ingredient sourcing and testing to sterile production processes and final sterility testing. This ensures that the medications we compound and provide are of the highest possible quality, consistency, and sterility for the patients and practitioners we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but are not available commercially. Our operations at 2160 W State Road 434 are designed to support healthcare providers with a reliable source of high-quality compounded medications. We produce formulations in larger batches for office use, allowing healthcare practitioners in our community to have essential medications readily available for immediate patient care. This is a critical service that enhances the efficiency and effectiveness of local medical practices, surgical centers, and other healthcare entities by providing them with access to vital medications that are compounded under the most stringent FDA oversight.
Our state-of-the-art facility at 2160 W State Road 434 is equipped to handle complex sterile and non-sterile compounding. A significant portion of our work involves the production of sterile injectables, including IV bags, syringes, and other parenteral medications that require an aseptic processing environment. Our cleanrooms are meticulously controlled and monitored to meet cGMP standards, and our highly trained staff follows exacting protocols to prevent contamination. Every batch of sterile compounded medication undergoes rigorous testing to verify sterility and potency before it is released, providing an unparalleled level of safety and assurance for the patients in Longwood who depend on these critical therapies.
503B Compounding Pharmacy is committed to serving the specific needs of the local healthcare community from our facility at 2160 W State Road 434. We work directly with physicians, veterinarians, and other healthcare providers to supply them with the compounded medications necessary for their practice. Our role is to be a trusted partner in patient care, ensuring that practitioners have access to FDA-registered outsourcing facility quality products. We encourage local healthcare providers to reach out to discuss how our 503B compounding services can support their practice. You can learn more about our specific operations and capabilities by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us directly at (407)993-1381.
Frequently Asked Questions
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 complies with federal current good manufacturing practice (cGMP) regulations. This is a different regulatory standard than a traditional compounding pharmacy, focusing on larger-scale production with enhanced testing and quality control protocols.
Who can receive medications from 503B Compounding Pharmacy? 503B Compounding Pharmacy primarily supplies compounded medications to healthcare practitioners for office use. This means physicians, veterinarians, and other licensed healthcare professionals at practices near our Longwood location can order from us to have medications on hand for immediate patient treatment. We do not typically dispense directly to individual patients without a specific agreement.
What types of medications does 503B Compounding Pharmacy produce? Our facility at 2160 W State Road 434 specializes in compounding both sterile and non-sterile medications in larger batches. This includes a wide range of sterile injectables, such as IV solutions and hormone injections, as well as non-sterile preparations like topical creams and capsules, all produced under the strict standards required of a 503B outsourcing facility.
How does the quality assurance at a 503B outsourcing facility differ? As a 503B outsourcing facility, we are required to adhere to cGMP standards. This involves rigorous testing of incoming ingredients, validated sterile compounding processes, environmental monitoring of our cleanrooms, and end-product sterility and potency testing on every batch of medication. This level of quality control is a fundamental requirement of our operation at 2160 W State Road 434.
How can a local healthcare provider place an order with 503B Compounding Pharmacy? Healthcare providers serving patients in the area can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific medication needs. You can initiate this process by calling our facility at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information on our ordering procedures and available formulations.