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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest current good manufacturing practices (cGMP) to ensure the quality, safety, and efficacy of every preparation that leaves our facility. We serve healthcare providers by providing them with essential medications that are not commercially available, enabling them to better treat their patients' unique needs.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. As a 503B outsourcing facility, our processes are subject to rigorous FDA oversight, including routine inspections. This provides an additional layer of assurance for the medical community at 2160 W State Road 434, Longwood, FL 32779. We compound a significant volume of medications, including injectables, ophthalmics, and other dosage forms, which are then distributed to hospitals, clinics, and physician offices for patient use. Our commitment is to supply safe and reliable compounded preparations to support the local healthcare infrastructure.
Healthcare professionals seeking a trusted source for compounded medications will find that 503B Compounding Pharmacy is a vital partner. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by experienced pharmacists and technicians who are experts in sterile compounding techniques. We focus on consistency, precision, and sterility in every batch we produce. By working directly with prescribers, we help fulfill specific patient prescriptions and provide medications for office use, ensuring practitioners have the necessary tools for patient care.
For more information about our services or to discuss your specific needs, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance at https://503bcompoundingpharmacy.com/. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to assist the medical community with high-quality compounded pharmaceutical solutions.
FAQ
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 FDA and operates under Section 503B of the FD&C Act. We are subject to federal oversight and must comply with strict current good manufacturing practices (cGMP), which includes rigorous testing and quality control standards beyond those of a traditional compounding pharmacy.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy distributes compounded medications to healthcare providers and facilities. Medications are provided for office use or to fulfill specific patient prescriptions as ordered by a licensed prescriber. We serve the healthcare providers who treat patients in need of our compounded preparations.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in the large-scale compounding of both sterile and non-sterile medications. This includes a range of preparations such as injectables, ophthalmics, and other formulations that are not readily available from commercial manufacturers, all produced at our facility on 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at 503B Compounding Pharmacy?
Our quality assurance process is comprehensive and mandated by cGMP standards. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes stringent testing for potency, sterility, and endotoxins before it is released, ensuring the highest level of safety and efficacy for patients.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will assist with the ordering process and answer any questions regarding our available medications and services from our location at 2160 W State Road 434, Longwood, FL 32779.