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 large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, providing healthcare providers and patients with medications they can trust. Unlike traditional compounding, our 503B status means our processes, testing, and controls meet rigorous federal standards, ensuring batch-to-batch consistency and sterility assurance for all our preparations.
The core function of 503B Compounding Pharmacy is the production of medications in anticipation of receiving patient-specific prescriptions. This allows us to supply healthcare facilities, such as clinics and physician offices located near our facility, with vital medications that are often in short supply or unavailable from conventional manufacturers. Our team of skilled pharmacists and technicians utilizes advanced technology and stringent protocols to compound a range of preparations, including sterile injectables, ophthalmic solutions, and topical formulations. Every step, from ingredient sourcing to final packaging, is meticulously controlled and documented within our Longwood facility to guarantee the integrity of every product that leaves our pharmacy.
We serve as a critical partner to local medical professionals by providing them with access to high-quality, compounded medications necessary for their practice and patient care. By working directly with healthcare providers in our community, we help ensure that patients receive the specific medications they need. Our location at 2160 W State Road 434, Longwood, FL 32779 is central to our mission of supporting the local healthcare ecosystem with reliable pharmaceutical compounding services that adhere to the strictest federal guidelines set forth for 503B outsourcing facilities.
For more information about the services provided by our 503B outsourcing 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 highest principles of pharmaceutical compounding at our location on W State Road 434.
What is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered entity that compounds human drugs in accordance with the strict regulations of Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under these heightened standards, which include current Good Manufacturing Practices (cGMP), to produce medications for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our facility are intended for office use and are distributed to licensed healthcare practitioners. We provide medications to medical professionals for administration to patients within their practice located near our facility at 2160 W State Road 434, Longwood, FL 32779.
Does 503B Compounding Pharmacy compound medications for individual patients?
No. As a 503B outsourcing facility, our primary function is to compound medications in larger batches for office use by healthcare providers. We do not compound patient-specific prescriptions directly for the public from our location on W State Road 434.
How does the 503B model benefit healthcare providers near your location?
Healthcare providers utilizing our services benefit from access to high-quality, FDA-registered compounded medications that are produced under rigorous cGMP standards. This ensures consistency, sterility, and reliability for the medications they use in treating their patients, all sourced from a local 503B outsourcing facility.
How can I contact your facility for more information?
You can contact 503B Compounding Pharmacy directly for more information by calling (407)993-1381. Our team is available to answer questions regarding our services and compliance as a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779.