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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing medications in larger batches for office use by healthcare practitioners or for distribution to hospitals and clinics, without patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, compounded medications that are not commercially available. The medications prepared at our 2160 W State Road 434, Longwood, FL 32779 location are manufactured under current good manufacturing practices (cGMP). This ensures every formulation meets rigorous standards for potency, purity, and sterility. Our state-of-the-art facility is designed to control for environmental contaminants, and our processes are validated to guarantee consistency and reliability in every batch we produce.
Healthcare professionals in need of compounded medications for their practice can rely on 503B Compounding Pharmacy. Our team of experienced pharmacists and technicians utilizes premium-quality ingredients and advanced technology to compound a range of preparations. By serving as a critical partner to local practitioners, 503B Compounding Pharmacy helps ensure patient access to essential medications that fulfill specific clinical needs not met by commercially available drug products.
For more information about the services provided by 503B Compounding Pharmacy, you can visit our website at or contact us directly by phone at (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is committed to supporting the local medical community with dependable, high-quality compounded pharmaceutical products.
Frequently Asked Questions
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 are subject to federal oversight and must comply with Current Good Manufacturing Practices (cGMP), which are stringent regulations for drug manufacturing that ensure product quality, safety, and sterility.
2. Can I as an individual patient order medications directly from 503B Compounding Pharmacy?
No. 503B outsourcing facilities provide medications for "office use" or for distribution to healthcare facilities. This means we supply compounded medications to physicians, hospitals, and clinics based on their orders, not on individual patient prescriptions. Patients must receive these medications through their healthcare provider.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our facility prepares a range of sterile and non-sterile compounded medications in batches. This can include, but is not limited to, sterile injectables, ophthalmics, hormone therapy preparations, and other formulations that are in short supply or not available from commercial pharmaceutical manufacturers.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can place orders for compounded medications by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will work with the provider to process their order for office-use medications to be used within their practice.
5. Why would a healthcare provider choose 503B Compounding Pharmacy over a traditional 503A pharmacy?
Healthcare providers may choose our 503B outsourcing facility because we manufacture medications under cGMP standards, which are typically more rigorous than the standards applied to traditional compounding pharmacies. This provides an additional layer of quality and safety assurance for medications intended for office use without a patient-specific prescription.