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 sterility in pharmaceutical compounding. As a 503B outsourcing facility, we produce large batches of compounded medications for office use, which are then distributed to healthcare practitioners for patient administration within their clinical practices. This model is distinct from traditional compounding and is designed for medications that are in significant demand and are medically necessary but may be commercially unavailable.
The operations at our Longwood facility are conducted under rigorous quality control protocols that meet and exceed FDA standards. This includes extensive testing of components, in-process materials, and finished drug products to ensure potency, purity, and sterility. The environment at 2160 W State Road 434 is meticulously controlled, with state-of-the-art air filtration systems and cleanrooms that adhere to strict federal guidelines. Every compounded preparation that leaves our facility is the product of a highly regulated and monitored process, providing healthcare providers with a trusted source for critical medications.
Our core service at 2160 W State Road 434, Longwood, FL 32779 is the provision of office-use compounded medications for physicians, hospitals, surgical centers, and other healthcare entities. We do not provide medications directly to individual patients from this location. Instead, we serve as a vital link in the healthcare chain, supplying practitioners with the specific sterile and non-sterile preparations they require to treat their patients effectively. Healthcare professionals can rely on the consistent quality and reliability of our products, allowing them to focus on patient care with the confidence that their pharmaceutical needs are being met by a dedicated and compliant outsourcing facility.
For healthcare providers seeking a dependable source for compounded pharmaceuticals, 503B Compounding Pharmacy at 2160 W State Road 434 represents a partnership built on quality and compliance. We invite local medical practices to contact us to discuss their specific needs. You can reach our facility at (407)993-1381 or visit us online at . Our team is dedicated to supporting the local medical community with high-quality, FDA-registered compounded medications.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility? It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We operate as an outsourcing facility, producing large volumes of compounded medications for office use by healthcare practitioners under stricter federal standards than traditional compounding pharmacies.
2. Can I, as an individual patient, pick up a prescription at your Longwood location? No. 503B Compounding Pharmacy provides medications for office use only to healthcare practitioners and facilities. Individual patients should work with their prescribing doctor who can obtain our products for administration within their practice at 2160 W State Road 434.
3. What types of medications do you compound at your facility? As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile preparations that are in high demand but may be on shortage or commercially unavailable. Healthcare providers can contact us at (407)993-1381 to inquire about specific formulations available from our Longwood location.
4. How does the quality assurance at your Longwood facility work? Our facility at 2160 W State Road 434 adheres to rigorous FDA-mandated quality control standards. This includes testing raw materials, validating our processes, and performing sterility and potency testing on finished products to ensure every preparation meets exacting specifications for safety and efficacy.
5. How can a local medical office order from your pharmacy? Local healthcare practices and facilities can establish an account with us by calling (407)993-1381. Our team will guide you through the process for ordering the compounded medications you need for your practice directly from our location at 2160 W State Road 434, Longwood, FL 32779.