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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to our mission of providing high-quality compounded medications for office use by healthcare practitioners. Our facility at 2160 W State Road 434, Longwood, FL 32779 is specifically designed and regulated to produce large volumes of sterile and non-sterile compounded preparations. We adhere to the most stringent current good manufacturing practices (cGMP) to ensure the safety, potency, and purity of every preparation that leaves our facility.
The core service of 503B Compounding Pharmacy is the provision of office stock medications for physician offices, hospitals, and clinics. This means healthcare professionals at our local address can confidently source essential medications directly from our facility to have on hand for patient procedures and treatments. By operating under Section 503B, we provide a critical alternative to traditional pharmaceutical manufacturers, particularly for drugs that are on the FDA’s drug shortage list or are not otherwise commercially available. Our team of licensed pharmacists and skilled technicians utilizes state-of-the-art equipment and rigorous testing protocols to meet the specific needs of the medical community we serve.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a hub for quality and reliability. The 503B outsourcing facility model ensures a level of oversight and quality control that goes beyond traditional compounding. Every process, from ingredient sourcing to final packaging, is meticulously documented and controlled. This provides assurance to healthcare providers that the medications they administer to their patients are produced under the highest standards. We are committed to supporting the local medical community by being a dependable partner for their compounded pharmaceutical needs.
For more information about the services available from our facility, you can visit our website at or contact us directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy is dedicated to upholding the principles of quality, safety, and compliance in every preparation we compound.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility? It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and regulated under Section 503B of the Federal Food, Drug, and Cosmetic Act. We comply with current good manufacturing practices (cGMP) and are subject to regular FDA inspections, which ensures a higher level of oversight for the sterile and non-sterile medications we compound for office use.
2. Who can receive medications from your 503B Compounding Pharmacy? Our facility provides medications for office use to healthcare practitioners and entities. This includes physicians, surgeons, clinics, and hospitals that are located at our address and require compounded preparations for their practice. We do not compound medications for individual patient prescriptions directly; we supply healthcare providers who then administer or dispense to their patients.
3. What types of medications do you compound at your location? At our facility on 2160 W State Road 434, Longwood, FL 32779, we compound a range of sterile and non-sterile preparations. This includes injectables, ophthalmics, topicals, and other dosage forms that are often used in clinical settings. Many of these are medications that are on the FDA drug shortage list or are not available from conventional manufacturers.
4. How does the quality control process work at your facility? Quality control is integral to our operation as a 503B outsourcing facility. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for sterility, potency, and endotoxins where applicable. We maintain extensive documentation and adhere to strict environmental monitoring and process validation protocols as required by cGMP standards.
5. How can a healthcare provider at this location place an order? Healthcare providers can place an order for office stock compounded medications by contacting our facility directly. You can reach us by phone at (407)993-1381 to speak with a representative about your specific needs and our available preparations. Our website also provides information for prospective clients.