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, producing medications in bulk for healthcare facilities without patient-specific prescriptions. 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 batch of medication we produce meets stringent standards for potency, purity, and sterility.
The primary function of 503B Compounding Pharmacy is to provide healthcare providers with access to essential medications that are often in short supply or unavailable from conventional manufacturers. By operating from our location at 2160 W State Road 434, Longwood, FL 32779, we serve as a critical component of the local healthcare infrastructure. Our facility is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists, pharmacy technicians, and quality assurance professionals. This team is committed to a meticulous process that encompasses every stage of production, from sourcing high-quality active pharmaceutical ingredients (APIs) to final packaging and labeling.
Our services at 2160 W State Road 434, Longwood, FL 32779, are focused on providing healthcare facilities with a reliable and compliant source for compounded medications. We compound a significant volume of injectable medications, including IV bags, syringes, and other sterile preparations that are vital for hospital and clinic use. The 503B outsourcing model allows us to provide these medications efficiently, helping to mitigate drug shortages and support the continuity of patient care for practitioners who rely on our facility. All products are tested for sterility and potency in our quality control lab to ensure they meet all specified requirements before they are released for distribution.
Compliance and patient safety are the cornerstones of our operation at 2160 W State Road 434, Longwood, FL 32779. As an FDA-registered 503B outsourcing facility, we undergo regular FDA inspections and are required to report adverse events. Our commitment to transparency and quality is unwavering. We provide healthcare professionals with the assurance that the medications they administer are produced under the most controlled and monitored conditions. For more information about our services or to discuss your facility's needs, please contact us at our facility or by phone at (407)993-1381. Our website, , also provides valuable resources for healthcare providers.
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 in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring the medications we compound meet the highest standards for safety, quality, and purity.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare facilities, such as hospitals, clinics, and surgical centers. We do not compound medications for individual patients based on a personal prescription. Our services are exclusively for institutional use, and orders must be placed by authorized healthcare providers or facility procurement personnel.
3. What types of medications are compounded at your facility on State Road 434?
At our location, 2160 W State Road 434, Longwood, FL 32779, we specialize in compounding sterile injectable medications. This includes a wide range of preparations like IV bags, syringes, and other parenteral medications that are essential for use in hospital and clinical settings, particularly those that may be experiencing a drug shortage.
4. How does the quality control process work at your Longwood facility?
Quality control is integral to our operation. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779, undergoes rigorous testing in our on-site quality control laboratory. This includes testing for sterility, potency, endotoxins, and other quality attributes to ensure the product is safe and effective before it is released for distribution to healthcare facilities.
5. How can a healthcare facility place an order with your pharmacy?
Healthcare facilities interested in our services can initiate the process by contacting our team directly at (407)993-1381. Our staff will provide information on our available products, discuss specific needs, and guide you through the onboarding and ordering process. You can also find more information on our website at .