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, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring that every preparation meets stringent federal quality standards for strength, identity, purity, and quality.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. These medications are produced in advance of receiving a patient-specific prescription and are intended for office use by healthcare practitioners. Our services are essential for medical practices, hospitals, clinics, and healthcare providers located at and serving patients from our area. We provide these practitioners with access to critical medications that may be in short supply, discontinued, or not otherwise commercially available, enabling them to better serve their patient community.
Our state-of-the-art facility at 2160 W State Road 434 is designed to maintain the utmost environmental control. Our cleanrooms are continuously monitored to ensure they meet the exacting standards required for producing sterile injectables, ophthalmics, and other preparations. Every step of our process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This provides healthcare professionals with the confidence that the medications they utilize are of consistent and reliable quality, batch after batch.
503B Compounding Pharmacy provides a vital service to the local healthcare ecosystem. By supplying healthcare practitioners with high-quality, FDA-registered compounded medications, we support the delivery of personalized patient care. Our presence at 2160 W State Road 434, Longwood, FL 32779, ensures that area providers have a reliable and compliant partner for their compounding needs. We are dedicated to upholding the principles of quality and safety inherent in our 503B status for the benefit of the medical community we serve.
For more information, please contact us via our website at or by phone at (407)993-1381.
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 comply with Current Good Manufacturing Practices (cGMP) and are subject to federal oversight and routine FDA inspections, ensuring a higher level of quality control for our compounded medications compared to a traditional pharmacy.
2. Can I get a prescription filled for myself at 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we do not accept individual patient prescriptions. We produce medications in larger batches for office use by healthcare practitioners. Your local healthcare provider at their practice can order and utilize our preparations for patient care.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our facility specializes in compounding sterile preparations, such as injectables and ophthalmics, as well as non-sterile preparations. These are often medications that are on drug shortage lists, have been discontinued by manufacturers, or are not commercially available in the strength or form a healthcare provider requires.
4. Who is eligible to order from 503B Compounding Pharmacy?
Orders are accepted from licensed healthcare practitioners and healthcare facilities for office use. This includes physicians, surgeons, veterinarians, and other eligible medical professionals who serve patients and require compounded medications for their practice located near our facility.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. Please visit our website at or call us at (407)993-1381 to speak with a representative about setting up an account and discussing your specific compounding needs.