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 operates as an FDA-registered outsourcing facility in strict compliance with 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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing medications in larger batches for healthcare facilities without patient-specific prescriptions. Our core mission is to provide healthcare providers with access to essential medications that are often in shortage or unavailable from conventional manufacturers.
The operations at our 2160 W State Road 434 location are governed by rigorous Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility meets stringent standards for potency, purity, and sterility. The 503B compounding pharmacy model allows us to supply physician offices, hospitals, and clinics with critical medications they require for patient care. Our team of highly trained pharmacists and technicians utilizes state-of-the-art technology and equipment within our facility to ensure precision and quality in every batch we compound.
We encourage healthcare professionals to contact us to discuss their specific medication needs. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our team is ready to provide information and support for the healthcare community we serve from our location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. We compound medications in larger batches for healthcare facilities, adhering to strict federal manufacturing standards, including Current Good Manufacturing Practices (cGMP), which are more rigorous than traditional pharmacy compounding standards.
2. Can I, as an individual patient, get a prescription filled at your location?
No. As a 503B outsourcing facility, we do not accept prescriptions for individual patients. Our medications are prepared in bulk for healthcare providers and institutions. Individual patients should contact a traditional 503A compounding pharmacy for their personal prescription needs.
3. Who can order medications from your 503B Compounding Pharmacy?
We supply compounded medications to healthcare professionals and facilities, such as hospitals, clinics, surgery centers, and physician offices. Orders are placed by the facility or provider, not by individual patients. All inquiries can be directed to (407)993-1381.
4. How does the quality control at your facility ensure medication safety?
Our operations at 2160 W State Road 434 are bound by cGMP regulations. This involves extensive testing of components, in-process monitoring, finished preparation testing, environmental monitoring, and rigorous validation of all our processes and equipment to ensure every batch meets defined specifications for quality, strength, and sterility.
5. How can a healthcare facility place an order with your pharmacy?
Healthcare facilities interested in our services should contact us directly at (407)993-1381 or visit our website at . Our team will provide information on our available medications, ordering process, and how we can support your specific patient care needs from our location in Longwood.