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 providers to administer to their patients within clinical settings or to dispense pursuant to a prescription.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded drugs that are not available commercially. Our operations at 2160 W State Road 434, Longwood, FL 32779 are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent standards for potency, purity, and sterility. We serve a critical role in the healthcare supply chain, providing hospitals, clinics, and other healthcare entities with essential medications that are often in short supply or unavailable from traditional manufacturers.
Our services at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding. We do not prepare patient-specific medications based on individual prescriptions. Instead, 503B Compounding Pharmacy produces batches of medications that are distributed to healthcare facilities. This model allows us to achieve economies of scale and maintain a consistent, reliable supply of vital drugs. Healthcare professionals can confidently utilize our products, knowing they are sourced from an FDA-registered and inspected outsourcing facility.
For any inquiries regarding our services or to place an order, please contact 503B Compounding Pharmacy directly. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to assist healthcare providers with their medication needs. You can reach 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. We are subject to federal oversight and must comply with current Good Manufacturing Practice (cGMP) regulations, which are the same standards followed by major pharmaceutical manufacturers.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not accept prescriptions from or dispense medications directly to individual patients. Our facility at 2160 W State Road 434, Longwood, FL 32779 provides compounded medications in bulk to healthcare facilities and providers, such as hospitals, clinics, and physician offices, who then administer or dispense them to patients.
3. What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy produces a wide range of sterile and non-sterile compounded medications that are often on drug shortage lists or are not commercially available. This includes injectables, ophthalmics, and other preparations essential for hospital and clinical use, all manufactured at our location: 2160 W State Road 434, Longwood, FL 32779.
4. How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities interested in our services should contact 503B Compounding Pharmacy directly to establish an account and discuss their specific needs. Orders can be coordinated through our team at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting our website at .
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 ensures you are sourcing medications from an FDA-registered outsourcing facility that is compliant with cGMP standards. This provides a higher level of assurance regarding the quality, safety, and consistency of the compounded drugs you administer to your patients.