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 operates as an FDA-registered outsourcing facility 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. This designation signifies our commitment to adhering to the most rigorous federal standards for quality, safety, and production. Unlike traditional compounding, our 503B status means our processes, testing, and facility are subject to ongoing FDA inspection, providing an elevated level of assurance for the medications we prepare.
The core function of our operation at this location is to provide bulk compounded medications for healthcare providers. We serve hospitals, clinics, and other healthcare entities by producing significant quantities of medications that are often in short supply or are not available from conventional pharmaceutical manufacturers. By operating from our specific address at 2160 W State Road 434, Longwood, FL 32779, we are positioned to be a reliable and consistent source of critical medications, helping to ensure patient care is not interrupted by national drug shortages.
Our 503B Compounding Pharmacy facility employs state-of-the-art technology and stringent environmental controls to guarantee the sterility and potency of every preparation. Every batch is compounded by highly trained professionals following current Good Manufacturing Practices (cGMP). This meticulous approach to compounding at our Longwood location minimizes the risk of contamination and ensures that each medication meets precise specifications before it is released for distribution to the practitioners who depend on us.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to uncompromising quality and reliability. We focus on the specific needs of institutional practice, providing a vital service from our dedicated outsourcing facility.
To learn more about our services or to speak with our team, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B outsourcing facility?
It means our pharmacy 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 adhere to more rigorous federal standards, including current Good Manufacturing Practices (cGMP), and undergo regular FDA inspections, unlike traditional compounding pharmacies.
2. Can I as an individual patient pick up my prescription at your location?
No. As a 503B outsourcing facility, our primary function is to compound large quantities of medications for healthcare facilities and practitioners. We do not typically dispense medications directly to individual patients at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider will receive the medication from us and dispense it to you as part of your treatment.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectables, IV preparations, and other medications that are often on drug shortage lists. We produce these in larger batches for use by hospitals, surgery centers, and clinics to support their patient care services.
4. How does the quality control process work at your facility?
Quality control is paramount. At our location, every batch of medication undergoes rigorous testing for sterility, potency, and endotoxins before it is released. Our cleanrooms are meticulously controlled, and our processes strictly follow cGMP guidelines to ensure the highest level of safety and efficacy for all preparations made at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare facility place an order with your pharmacy?
Healthcare facilities and providers can initiate orders by contacting our team directly. For ordering information and to discuss your specific needs, please reach out to us via our website at or by calling our main line at (407)993-1381. Our staff at 2160 W State Road 434, Longwood, FL 32779 will guide you through the process.