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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under 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. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing medications for healthcare providers and facilities in need of bulk compounded preparations. Our operations are distinct from traditional compounding pharmacies, as we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent standards for potency, purity, and sterility.
The services provided by 503B Compounding Pharmacy at our Longwood location are designed to support the specific needs of healthcare practitioners and facilities. We compound medications that are commercially unavailable or are in shortage, ensuring patient care is not interrupted. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment and technology within our controlled environment to produce consistent, high-quality preparations. We maintain a robust quality assurance program, which includes stringent environmental monitoring, validation of sterilization processes, and stability testing to guarantee the integrity of our products from our facility to the end-user.
Our location at 2160 W State Road 434, Longwood, FL 32779 is the center of our operations. We do not serve patients directly but work exclusively with healthcare professionals and institutions. By focusing on the specific needs of our clients at this location, we ensure a reliable supply of essential medications. The 503B Compounding Pharmacy team is committed to excellence, compliance, and supporting the local healthcare community with dependable pharmaceutical compounding services. For more information or to discuss your facility's needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
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 subjects us to federal oversight and compliance with current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures a higher level of quality control for the medications we compound.
2. Who can order medications from 503B Compounding Pharmacy at this location?
Our services at 2160 W State Road 434, Longwood, FL 32779 are available to healthcare professionals and facilities, such as hospitals, clinics, and physician practices. We do not dispense medications directly to individual patients. Orders must be placed by and for use within a professional healthcare setting.
3. What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile injectables, ophthalmics, and other preparations that are on the FDA drug shortage list or are not commercially available. Our focus is on producing these medications in larger quantities for administration by healthcare providers at their facilities.
4. How does the quality control process work at your facility?
Our quality control at 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It includes testing raw materials, in-process testing, finished preparation potency and sterility testing, and ongoing environmental monitoring of our cleanrooms. All processes are strictly documented and validated to meet cGMP standards, providing assurance of the safety and efficacy of every product.
5. How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities interested in our services can initiate the process by contacting our team directly. You can reach us by phone at (407)993-1381 or through our website at . Our staff will provide information on our available preparations, ordering protocols, and how we can meet your specific medication needs.