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 quality control, sterility, and potency, providing a critical service for healthcare providers and patients who require medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. This means we supply healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with essential medications for their practice needs, including injectables, IV bags, and ophthalmic drops. Our operations are subject to rigorous FDA oversight, which includes current Good Manufacturing Practice (cGMP) regulations, ensuring every preparation meets exacting standards for safety and identity.
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 rely on our 503B outsourcing facility for a consistent and reliable supply of high-quality medications. We provide medications for office administration, surgical procedures, and emergency kits. By partnering with a 503B outsourcing facility, practitioners can be confident in the quality and consistency of the medications they use, allowing them to focus on patient care.
Our 503B Compounding Pharmacy is committed to serving the specific medical community at 2160 W State Road 434, Longwood, FL 32779. We operate under a framework designed to ensure patient safety through robust quality assurance protocols, environmental monitoring, and stringent testing. For more information or to discuss your facility's needs, please contact 503B Compounding Pharmacy at our phone number: (407)993-1381, or visit our website at .
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 subjects us to federal oversight, including compliance with current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional 503A compounding pharmacies.
2. Can I as an individual patient pick up my prescription directly from the 503B Compounding Pharmacy location?
No. As a 503B outsourcing facility, we primarily supply medications for office use by healthcare practitioners. Individual patient prescriptions are typically compounded and dispensed by 503A pharmacies. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 order compounded medications from us to administer to patients within their practice.
3. What types of medications does the 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our 503B outsourcing facility specializes in compounding sterile preparations (CSPs). This includes a wide range of medications such as injectable solutions, intravenous (IV) bags, hormone injections, ophthalmic drops, and other sterile products that are supplied in bulk to healthcare providers for use within their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How does the 503B Compounding Pharmacy ensure the sterility and safety of its products?
Our 503B outsourcing facility follows strict cGMP protocols. This involves comprehensive environmental monitoring of our cleanrooms, rigorous testing of components and finished products, validation of sterilization processes, and meticulous documentation. These procedures are a mandatory requirement for all 503B outsourcing facilities to ensure patient safety.
5. How can a healthcare provider at 2160 W State Road 434 place an order with your 503B Compounding Pharmacy?
Healthcare providers can contact our 503B outsourcing facility directly to establish an account and discuss their specific medication needs. You can reach us by phone at (407)993-1381 to speak with a representative or visit our website at for more information on our services and ordering process.