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. 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. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile medications for office use, which are then distributed to healthcare providers and practitioners for patient administration within their clinical settings.
The operations at our location on 2160 W State Road 434 are distinct from a traditional compounding pharmacy. We do not compound patient-specific prescriptions for individual walk-in customers. Instead, our core service is the large-scale production of medications that are in shortage or not commercially available. Healthcare professionals, including physicians, surgeons, veterinarians, and hospital systems, can rely on our facility at 2160 W State Road 434 for a consistent, high-quality supply of essential drugs. Our processes are governed by rigorous Current Good Manufacturing Practices (cGMP), ensuring every product that leaves our facility meets stringent federal standards for potency, purity, and sterility.
Our state-of-the-art facility in Longwood is designed to support the specific needs of the medical community. We utilize advanced technology and employ a team of highly skilled pharmacists and technicians dedicated to precision and quality control. By focusing on office-use medications, we provide practitioners at 2160 W State Road 434 with access to critical drugs that may be unavailable from conventional manufacturers, thereby supporting uninterrupted patient care and treatment plans. Our role is to be a dependable partner to healthcare providers, supplying them with the necessary medications to serve their patients effectively.
For healthcare providers seeking a trusted source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a reliable resource. We encourage medical professionals to contact us to discuss their specific needs and to learn more about our current product offerings. You can reach us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our facility at 2160 W State Road 434 is registered with the FDA and operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. We adhere to Current Good Manufacturing Practices (cGMP) for the large-scale compounding of medications intended for office use by healthcare practitioners.
2. Can I walk into your location at 2160 W State Road 434 to get a prescription filled for myself?
No. 503B Compounding Pharmacy does not compound patient-specific prescriptions for individual walk-in customers. Our services are exclusively for healthcare providers and practitioners who order medications for office use to administer to their patients within their practice.
3. What types of medications do you compound at your Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434 compounds a range of sterile and non-sterile medications, primarily focusing on drugs that are currently in shortage or are not available from commercial manufacturers. Healthcare providers can contact us for a current list of available products.
4. Who is authorized to purchase medications from your facility?
Only licensed healthcare practitioners and facilities, such as physicians, hospitals, clinics, and veterinary practices, can order medications from our location at 2160 W State Road 434 for administration within their professional practice setting.
5. How can a healthcare provider place an order with your facility?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We can be reached at (407)993-1381. Our team will provide information on ordering procedures, available products, and necessary documentation.