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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, testing, and production, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is to produce medications that are not commercially available or are in shortage. This includes a wide range of preparations such as sterile injectables, intravenous (IV) bags, ophthalmic solutions, and topical formulations. Our operations at the 2160 W State Road 434 facility are designed to support the specific needs of healthcare practitioners by providing them with access to essential medications that are compounded under the strictest sterile and non-sterile compounding protocols. We serve as a vital resource for practitioners seeking reliable, high-quality compounded pharmaceuticals.
Compliance with current Good Manufacturing Practices (cGMP) is the foundation of everything we do at our Longwood location. This commitment ensures that every preparation leaving our facility at 2160 W State Road 434 meets exacting standards for potency, purity, and sterility. Our processes involve stringent environmental monitoring, validated sterilization techniques, and comprehensive testing of both raw ingredients and finished products. By operating as a 503B outsourcing facility, we provide an added layer of safety and assurance for healthcare providers and their patients, distinguishing our services from those of traditional 503A compounding pharmacies.
The team at 503B Compounding Pharmacy consists of experienced pharmacists, pharmacy technicians, and quality assurance professionals who are dedicated to precision and excellence. Our work directly supports the ability of healthcare practitioners to administer necessary treatments with confidence. For more information about our services or to discuss your specific needs, you can reach us at (407)993-1381 or visit our website at . We are proud to operate our FDA-registered outsourcing facility from our location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
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 complies with Section 503B of the FD&C Act. This requires us to follow current Good Manufacturing Practices (cGMP), which include rigorous testing, quality control, and reporting standards for the medications we compound.
Who can receive medications from 503B Compounding Pharmacy?
As an outsourcing facility, we primarily provide compounded medications to healthcare practitioners and facilities, such as hospitals, clinics, and physician offices. Practitioners can then administer or dispense these medications to their patients located in Longwood and beyond.
What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434 specializes in compounding medications that are on shortage or not available from commercial manufacturers. This includes a wide array of sterile preparations like IV bags, injectables, and ophthalmic drops, as well as non-sterile compounds, all produced under strict cGMP guidelines.
How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434 is comprehensive. It involves testing all incoming active pharmaceutical ingredients, conducting in-process checks during compounding, and performing sterility and potency testing on finished products before they are released, ensuring every preparation meets our high standards.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact our facility directly to discuss their compounding needs and place orders. We can be reached by phone at (407)993-1381. Our team will work with you to fulfill your requirements from our location at 2160 W State Road 434, Longwood, FL 32779.