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, producing medications in larger batches for office use by healthcare practitioners, rather than for individual patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, compounded medications that are not otherwise commercially available. The medications prepared at our 2160 W State Road 434, Longwood, FL 32779 location are manufactured under a rigorous quality control system. This includes stringent environmental monitoring, validated processes, and extensive testing to ensure potency, purity, and sterility. Healthcare professionals can confidently utilize our medications for their patients, knowing they are sourced from a fully compliant 503B outsourcing facility.
Our services at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for the medical community. We supply physician offices, hospitals, clinics, and other healthcare institutions with the essential medications they require. The operations of 503B Compounding Pharmacy are distinct from traditional compounding pharmacies, as we produce medications for office use without the need for individual prescriptions. This allows healthcare providers to have critical medications on hand for immediate administration during procedures, treatments, or emergency situations.
The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in the art and science of compounding. Our staff is committed to upholding the precise regulations that govern an FDA-registered 503B outsourcing facility. Every step of the process at our location on 2160 W State Road 434, Longwood, FL 32779 is meticulously documented and controlled, from sourcing quality ingredients to the final packaging and labeling of our products. This unwavering commitment to compliance and excellence is the foundation of our operation.
503B Compounding Pharmacy provides a vital service to the local healthcare infrastructure from our facility at 2160 W State Road 434, Longwood, FL 32779. We are a reliable partner for healthcare providers, ensuring they have access to the necessary compounded medications to best serve their patients. For more information about our services or to speak with our team, please contact us via our website at or by phone at (407)993-1381.
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 under Section 503B of the FD&C Act. This requires us to comply with Current Good Manufacturing Practices (cGMP) for pharmaceuticals, which includes rigorous testing, environmental monitoring, and quality control standards that exceed those of a traditional pharmacy.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy prepares medications in bulk for office use by healthcare practitioners. We do not accept or compound medications based on individual patient prescriptions. Patients should contact their healthcare provider or a traditional compounding pharmacy for patient-specific medications.
3. Who can order medications from your facility at 2160 W State Road 434, Longwood, FL 32779?
Our services are exclusively for healthcare providers and institutions. This includes physicians, surgeons, dentists, veterinarians, hospitals, surgery centers, and clinics. Orders must be placed by a licensed healthcare professional for use within their practice.
4. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we produce a range of sterile and non-sterile compounded medications that are typically used in clinical settings. This includes, but is not limited to, sterile injectables, ophthalmics, and other preparations that are not commercially available from large pharmaceutical manufacturers.
5. How do I place an order or get more information for my practice?
Healthcare providers interested in our services can obtain more information or place an order by contacting 503B Compounding Pharmacy directly. You can reach us through our website at or by calling our main line at (407)993-1381. Our team will be happy to assist you.