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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical quality, producing medications in larger batches for healthcare providers without patient-specific prescriptions. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring every preparation meets exacting standards for sterility, potency, and purity.
The core function of 503B Compounding Pharmacy is to provide healthcare practitioners with access to high-quality, ready-made compounded medications. We serve as a critical component of the healthcare supply chain, offering medications that are often on shortage or are not commercially available from traditional pharmaceutical manufacturers. The team at our Longwood facility consists of highly skilled pharmacists and technicians who utilize state-of-the-art equipment and technology to compound a range of sterile preparations. This includes intravenous (IV) bags, hormone injections, ophthalmic solutions, and other essential medications that are vital for patient care in various clinical settings.
Healthcare providers who partner with 503B Compounding Pharmacy at 2160 W State Road 434 can be confident in the integrity and safety of the medications they administer. Our commitment to quality control is paramount; each batch undergoes extensive testing and validation processes before it is released. This level of assurance is a fundamental benefit of sourcing medications from an FDA-registered 503B outsourcing facility. By choosing our services, medical professionals can mitigate risks associated with drug shortages and ensure their patients receive consistent, reliable, and effective treatments.
We invite healthcare facilities and practitioners to connect with 503B Compounding Pharmacy to learn more about our current offerings and how we can support your practice. Our team is dedicated to providing exceptional service and reliable access to necessary medications. For more information or to discuss your needs, please contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our facility is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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 requires us to comply with stringent current Good Manufacturing Practice (cGMP) regulations, which include rigorous testing for sterility, potency, and stability on all our compounded preparations.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare practitioners and facilities, such as hospitals, clinics, and physician offices. We do not compound medications based on individual patient prescriptions for the public. Our services are designed to supply healthcare providers with batch-produced medications for office use.
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 preparations. This includes a range of products like intravenous (IV) solutions, injectable medications, ophthalmic drops, and other sterile formulations that are essential for healthcare providers but may be in short supply or unavailable from standard manufacturers.
4. How does 503B Compounding Pharmacy ensure medication safety?
Safety is ensured through strict adherence to cGMP standards. Every batch of medication produced at our Longwood facility undergoes comprehensive quality control testing, including sterility testing, endotoxin testing, and potency assays, before it is released for distribution to healthcare providers.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific needs. You can reach our team by calling (407)993-1381. Our facility is located at 2160 W State Road 434, Longwood, FL 32779.