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 at 2160 W State Road 434, Longwood, FL 32779. Our operations are conducted in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation signifies our commitment to producing compounded medications under the highest standards of quality, safety, and regulatory oversight. As a 503B outsourcing facility, we adhere to Current Good Manufacturing Practices (cGMP), which ensures that every preparation leaving our facility meets rigorous testing and quality assurance protocols. Our primary focus is on providing bulk quantities of sterile and non-sterile compounded preparations for healthcare facilities and practitioners, enabling them to better serve their patients.
The services provided by 503B Compounding Pharmacy at our location on 2160 W State Road 434 are distinct from traditional compounding. We do not provide individualized prescriptions for walk-in patients. Instead, we supply healthcare providers with essential medications that are often in shortage or are not commercially available. Our team of highly skilled pharmacists and technicians utilizes state-of-the-art equipment and cleanroom environments to compound preparations with precision and accuracy. This allows hospitals, clinics, and other healthcare entities in need of a reliable supplier to access critical medications, confident in their quality, potency, and sterility.
Our facility at 2160 W State Road 434 is designed to support the specific needs of the medical community. We offer a range of compounded preparations, including intravenous (IV) bags, hormone injections, ophthalmics, and other sterile products. Each batch is meticulously prepared and undergoes stringent quality control testing to verify sterility, potency, and purity. By operating as a 503B outsourcing facility, we provide a vital service, helping to mitigate drug shortages and ensuring that practitioners have access to the necessary medications for their treatment protocols. Our dedicated team is committed to excellence in every aspect of our operation, from raw material sourcing to final product release.
Engaging with 503B Compounding Pharmacy means partnering with a trusted and compliant source for compounded medications. Healthcare providers can rely on our consistent quality and regulatory adherence for their patient care needs. We invite medical facilities and practitioners to contact us to discuss how our services can support their operations. For more information or to initiate an order, please reach out to us via our website at or by phone at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
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 FD&C Act. We adhere to Current Good Manufacturing Practices (cGMP) for the compounding of medications, which includes rigorous testing for sterility, potency, and purity.
2. Can I walk into the facility at 2160 W State Road 434 to get a prescription filled for myself?
No. 503B Compounding Pharmacy does not compound patient-specific prescriptions. We supply compounded medications in bulk to healthcare facilities and practitioners. Individual patients should contact their healthcare provider or a traditional compounding pharmacy for personal prescriptions.
3. What types of medications does 503B Compounding Pharmacy produce at its Longwood location?
At our facility on 2160 W State Road 434, we compound a variety of sterile and non-sterile preparations, including IV solutions, injectables, and ophthalmics. These are primarily provided to hospitals, clinics, and other healthcare providers to address patient needs and drug shortages.
4. How does a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities and practitioners can place orders by contacting 503B Compounding Pharmacy directly. You can reach our team at our location, 2160 W State Road 434, Longwood, FL 32779, by phone at (407)993-1381, or through our website at .
5. Why should a healthcare provider choose 503B Compounding Pharmacy for their compounded medication needs?
Healthcare providers should choose our facility because we operate as a 503B outsourcing facility, ensuring the highest level of regulatory compliance and quality control. Our medications are produced under cGMP standards, providing assurance of safety, efficacy, and consistency for their patients.