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 healthcare providers with access to medications that are not commercially available or are in shortage. 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 are specifically designed for healthcare professionals and facilities. We work directly with prescribers and hospitals to supply bulk compounded medications for office use. Our portfolio includes a wide array of compounded preparations, such as sterile injectables, ophthalmics, and other dosage forms that are essential for patient care. The team at our Longwood facility comprises highly skilled pharmacists and technicians who utilize state-of-the-art equipment and technology in a controlled environment to ensure the integrity of every compound. Our commitment is to be a reliable partner for the medical community at 2160 W State Road 434, Longwood, FL 32779, by delivering high-quality medications that help meet the unique needs of their patients.
For healthcare providers seeking a trusted source for compounded medications, 503B Compounding Pharmacy offers a critical service. Our location at 2160 W State Road 434, Longwood, FL 32779 is a center for pharmaceutical compounding excellence, focused on compliance, safety, and reliability. We invite local medical practices and facilities to connect with us to learn how our services can support their practice. You can reach us via our website at or by phone at (407)993-1381 for more information or to discuss your specific compounding needs.
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 registration subjects us to federal oversight and requires us to comply with current Good Manufacturing Practices (cGMP), which are more rigorous standards than those applied to traditional compounding pharmacies.
2. Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare professionals and facilities. We supply medications for office use to prescribers and hospitals. Individual patient prescriptions are not dispensed directly to the public from our location at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in the large-scale compounding of medications, primarily sterile injectables and ophthalmics, that are often on shortage or are not available from commercial manufacturers. All preparations are compounded at our facility located at 2160 W State Road 434, Longwood, FL 32779.
4. How does 503B Compounding Pharmacy ensure medication quality and safety?
Our facility adheres to strict cGMP regulations. This includes rigorous testing of components, validated processes, environmental monitoring, and thorough quality control checks to ensure the potency, purity, and sterility of every medication we compound at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare facility at this location place an order?
Healthcare providers and facilities interested in our services can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific needs. Please reach out to us via our website at or call us at (407)993-1381 for more information.