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 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 large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and facilities by providing them with essential medications that are not commercially available or are in shortage, ensuring patient needs are met with reliability and precision.
The operations at our Longwood location are central to our mission. Within our state-of-the-art facility, our team of skilled pharmacists and technicians utilizes advanced technology and rigorous testing protocols to compound medications. Every batch produced is subject to stringent quality control measures, including sterility testing, endotoxin testing, and potency verification, to ensure each medication meets exact specifications. This process provides healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with the assurance that the medications they administer are of the highest quality and purity.
503B Compounding Pharmacy provides a critical service by addressing drug shortages. When commercially manufactured drugs become unavailable, our facility can step in to compound these vital medications, helping to prevent interruptions in patient care. We compound a significant volume of injectable medications, ophthalmics, and other sterile preparations that are essential for hospitals, clinics, and other healthcare providers. The ability to provide these medications from our location at 2160 W State Road 434, Longwood, FL 32779 is a key component of the local healthcare infrastructure.
As a 503B outsourcing facility, our primary relationship is with healthcare entities rather than individual patients. We work directly with physicians, hospitals, surgery centers, and other healthcare providers to supply the compounded medications they require for their practice and patient treatment plans. This business-to-business model allows us to focus our expertise on large-scale production while ensuring the healthcare professionals we serve can confidently obtain the medications they need from a trusted, regulated source at 2160 W State Road 434, Longwood, FL 32779.
Choosing 503B Compounding Pharmacy means partnering with a provider that prioritizes regulatory compliance and patient safety above all else. Our registration with the FDA and adherence to Current Good Manufacturing Practices (cGMP) are the foundation of everything we do. For healthcare providers seeking a reliable source for compounded medications, we invite you to connect with our team at our facility. You can learn more about our services and capabilities by visiting our website at or by calling us directly at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
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 of the Federal Food, Drug, and Cosmetic Act. This requires us to comply with more rigorous standards, including Current Good Manufacturing Practices (cGMP), and mandatory reporting of adverse events and product quality issues, providing a higher level of quality assurance for healthcare providers.
2. Can individual patients pick up prescriptions directly from your location?
No. As a 503B outsourcing facility, our primary business model is to supply compounded medications in bulk to healthcare providers and facilities, not directly to individual patients. Medications compounded at our location on W State Road 434 are distributed to hospitals, clinics, and physician offices for administration to their patients.
3. What types of medications do you compound at your Longwood facility?
At our facility at 2160 W State Road 434, Longwood, FL 32779, we specialize in compounding sterile preparations. This includes a wide range of injectable medications, intravenous (IV) bags, ophthalmics, and other solutions that are essential for healthcare providers. We focus on medications that are on shortage or are not available from commercial manufacturers.
4. How does your pharmacy help with drug shortages?
When a commercially manufactured drug goes on shortage, healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can turn to our 503B outsourcing facility. We have the capability to compound these critical medications on a larger scale, helping to ensure continuity of care and preventing treatment delays for patients in need.
5. How can a healthcare facility place an order with your pharmacy?
Healthcare facilities and providers can place orders by contacting our pharmacy directly. For more information on our services and to initiate an order, please call our team at (407)993-1381. You can also visit our website at for additional details about our capabilities and compliance standards.