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, providing medications for healthcare facilities and practitioners when a commercially available drug is not suitable for a patient's specific needs.
The operations at our Longwood location are distinct from traditional compounding. Our 503B status signifies that our processes, equipment, and cleanrooms are subject to rigorous FDA oversight and current good manufacturing practices (cGMP). This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility. We serve an important role in the healthcare continuum by providing bulk quantities of essential medications to hospitals, clinics, and other healthcare providers.
Our core service is the large-scale compounding of medications that are not available from standard pharmaceutical manufacturers. This includes creating formulations without certain allergens, adjusting dosages, or providing medications that are currently in shortage. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize advanced technology and precise protocols to ensure every preparation is accurate and reliable. Our commitment is to support the local medical community with a consistent and trusted supply of high-quality compounded preparations.
For more information about the services provided by our FDA-registered outsourcing facility, you can visit our website at or contact us directly at (407)993-1381. 503B Compounding Pharmacy 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 complies with specific federal regulations under Section 503B. We operate under current good manufacturing practices (cGMP) and are subject to regular FDA inspections, ensuring the highest level of quality and safety for our compounded preparations.
2. Who can receive medications from 503B Compounding Pharmacy?
As a 503B outsourcing facility, we primarily provide compounded medications in large quantities to healthcare facilities and practitioners, such as hospitals, clinics, and surgery centers. These entities then dispense the medications to their patients located at 2160 W State Road 434, Longwood, FL 32779 and other areas they serve.
3. How is a 503B outsourcing facility different from a traditional compounding pharmacy?
The key difference is the scale of production and regulatory oversight. While traditional compounders typically prepare patient-specific prescriptions, our 503B facility at 2160 W State Road 434, Longwood, FL 32779 compounds medications in larger batches without receiving individual prescriptions. We are regulated by the FDA under cGMP standards, which are typically applied to large-scale drug manufacturers.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in preparing sterile injectable medications, including IV bags, ophthalmics, and other preparations that require an aseptic environment. We focus on medications that are on shortage or are not commercially available to meet the specific needs of the healthcare providers we serve from our location at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers and facilities can initiate orders by contacting our facility directly. For ordering information and to discuss specific needs, please contact 503B Compounding Pharmacy at (407)993-1381. Our team will provide all necessary details regarding the ordering process for preparations compounded at 2160 W State Road 434, Longwood, FL 32779.