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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, and provides medications for office use by healthcare practitioners.
The primary function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is the large-scale production of sterile and non-sterile compounded preparations. These medications are distributed to healthcare providers and facilities for administration to their patients within a clinical setting. Our services are essential for hospitals, clinics, surgical centers, and other healthcare providers who require bulk quantities of high-quality, reliable medications that may be commercially unavailable or in short supply. We provide a critical component of the healthcare infrastructure, ensuring practitioners have access to the necessary pharmaceutical tools.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to maintain the utmost sterility and precision. We utilize advanced technology and stringent environmental controls to ensure every preparation meets exacting specifications. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who are experts in their field, dedicated to producing medications that healthcare professionals can trust implicitly for their patients. Quality assurance is embedded in every step of our process, from ingredient sourcing to final testing and release.
503B Compounding Pharmacy provides a vital service to the local medical community by compounding medications that are not readily available from commercial manufacturers. This includes creating formulations without certain allergens, producing specific dosages, or developing medications that have been discontinued. By operating from our location at 2160 W State Road 434, Longwood, FL 32779, we offer a reliable, local source for healthcare providers to obtain these essential pharmaceutical compounds, supporting the health and well-being of the community we serve.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at . Our facility is dedicated to supporting healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with the highest quality compounded medications.
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. We are subject to federal cGMP regulations and routine FDA inspections, which ensures a higher level of oversight and quality control compared to a traditional pharmacy.
2. Can I as an individual patient pick up my prescription directly from your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Individual patient prescriptions are typically dispensed by a traditional pharmacy. Healthcare providers order compounded medications from our facility at 2160 W State Road 434, Longwood, FL 32779 to administer to patients within their practice.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our facility specializes in preparing large-scale batches of both sterile and non-sterile compounded medications. This includes injectables, ophthalmics, and other preparations that are supplied in bulk to hospitals, clinics, and other healthcare providers for use within their practice.
4. How does a healthcare provider place an order with your facility?
Healthcare providers and facilities can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, available formulations, and delivery options from our location at 2160 W State Road 434, Longwood, FL 32779.
5. Why would a healthcare provider choose a 503B outsourcing facility over other compounders?
Healthcare providers choose a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 because of the enhanced federal oversight and guaranteed adherence to cGMP standards. This provides an added layer of safety, quality, and reliability for the medications they use to treat their patients.