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 at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to compound large quantities of sterile and non-sterile medications without receiving patient-specific prescriptions. This regulatory designation is a critical differentiator, signifying our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. We serve healthcare providers and facilities by providing them with essential medications that are often in shortage or unavailable from traditional manufacturers.
The operations at our Longwood location are governed by rigorous current good manufacturing practices (cGMP). This ensures that every preparation leaving our facility is produced under the most stringent quality control protocols. Our sterile compounding suites are environmentally controlled, and our personnel undergo extensive training and testing to maintain an aseptic processing environment. We utilize advanced analytical testing to verify the potency, purity, and sterility of our compounds, providing an unparalleled level of assurance for the medical community we serve at 2160 W State Road 434, Longwood, FL 32779.
Our core service is the preparation of medications in anticipation of receiving prescriptions, which allows us to supply healthcare providers with critical drugs promptly. This model is essential for hospitals, clinics, and other healthcare entities that require immediate access to compounded preparations. By operating as a 503B outsourcing facility, we alleviate the burden on in-house pharmacy departments, enabling them to focus on direct patient care while relying on our expertise for compliant, high-quality, and readily available medications. Our role is to be a dependable backbone for the local healthcare infrastructure.
We encourage healthcare professionals and facility administrators to contact us to discuss their specific needs. You can reach 503B Compounding Pharmacy directly at (407)993-1381 for more information on our available preparations and procurement processes. Detailed information about our compliance and services can also be found on our website at . Our team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the medical community with reliable pharmaceutical compounding services.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that you are a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict current good manufacturing practices (cGMP). We compound medications in larger batches for healthcare facilities without patient-specific prescriptions, focusing on drugs that are often on shortage or unavailable.
2. Can individual patients get prescriptions filled directly at your location?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare providers and facilities. Individual patients should work with their local compounding pharmacy or healthcare provider, who can then source appropriate medications from our facility at 2160 W State Road 434, Longwood, FL 32779 if needed.
3. Who are the primary clients you serve at your Longwood facility?
Our primary clients are institutional healthcare providers, including hospitals, surgery centers, clinics, and veterinary practices. We supply these entities with sterile injectables, ophthalmics, and other preparations compounded under cGMP standards at our location on W State Road 434.
4. How does your service ensure medication safety and quality?
Safety and quality are ensured through rigorous cGMP protocols. This includes environmental monitoring of our cleanrooms, extensive personnel training, validation of all processes, and thorough testing of finished products for sterility, potency, and purity before they are released from our facility.
5. How can a healthcare facility place an order with your pharmacy?
Healthcare facilities can initiate the ordering process by contacting our team directly at (407)993-1381. We will provide information on our available drug products and guide you through the required steps for establishing an account and placing orders from our location at 2160 W State Road 434, Longwood, FL 32779.