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 or for distribution to hospitals and clinics, without 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 commercially available. Our operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under a rigorous quality control system, which includes stringent environmental monitoring, validation of sterilization processes, and stability testing to ensure potency and purity. This level of oversight provides assurance to the medical community that the medications they utilize meet exacting standards for patient care.
Healthcare professionals seeking a reliable source for compounded medications can rely on the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779. Our facility is equipped to handle a range of compounding needs, ensuring that practitioners have the necessary tools to serve their patients effectively. We maintain a focus on consistency and reliability in every batch we produce.
For more information about the services provided by 503B Compounding Pharmacy, you can visit our website at or contact us directly by phone at (407)993-1381. Our team is prepared to assist healthcare providers with their specific medication requirements.
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 complies with federal regulations outlined in Section 503B. This includes adhering to Current Good Manufacturing Practices (cGMP) for higher-volume compounding, which involves more rigorous testing, quality control, and reporting standards compared to traditional compounding.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy prepares medications for office use by healthcare practitioners or for distribution to healthcare facilities. We do not compound medications based on individual patient prescriptions. Patients should work directly with their healthcare provider, who may utilize medications compounded at our facility located at 2160 W State Road 434, Longwood, FL 32779.
3. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your facility?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the process, discuss your specific needs, and provide information on available compounded medications for office use from our location.
4. What types of medications does 503B Compounding Pharmacy at this location prepare?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile and non-sterile medications in batches. This can include, but is not limited to, hormonal preparations, sterile injectables, ophthalmics, and other formulations that are not readily available from commercial manufacturers.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Healthcare providers choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are selecting an outsourcing facility that operates under federal cGMP standards. This provides an added layer of quality and safety assurance for the compounded medications used in their practice, supporting optimal patient outcomes.