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 designed to produce large volumes of compounded sterile preparations (CSPs) and compounded non-sterile preparations for healthcare providers. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, sterility testing, and current good manufacturing practices (cGMP), which differentiates our operations from traditional 503A compounding pharmacies. Our primary mission is to provide healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, reliable medications that are essential for patient care.
The services provided by 503B Compounding Pharmacy are exclusively available from our location at 2160 W State Road 434, Longwood, FL 32779. We specialize in the compounding of medications that are distributed for office use by physicians, surgeons, veterinarians, and other healthcare professionals. This includes a wide array of sterile preparations such as injectables, infusions, ophthalmics, and irrigation solutions. Our status as a 503B outsourcing facility means we can compound medications in advance of receiving a patient-specific prescription, allowing for immediate availability for procedural use, emergency kits, and other clinical needs at 2160 W State Road 434, Longwood, FL 32779.
Quality and safety are the cornerstones of our operation at 503B Compounding Pharmacy. Every process within our facility at 2160 W State Road 434, Longwood, FL 32779 is governed by strict cGMP protocols. This encompasses environmental monitoring, personnel training and competency evaluations, validation of sterilization processes, and stringent testing of components and finished drug products. By operating under these elevated standards, 503B Compounding Pharmacy ensures that every preparation leaving our facility meets precise identity, strength, quality, and purity characteristics. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize our medications, knowing they are produced under the highest level of regulatory oversight.
503B Compounding Pharmacy serves a critical role in the healthcare supply chain for practitioners based at 2160 W State Road 434, Longwood, FL 32779. We provide essential medications during times of drug shortages, produce formulations that are commercially unavailable, and offer alternatives when a marketed drug is not suitable for a patient's needs. Our facility is equipped with state-of-the-art technology and staffed by experienced compounding professionals, including pharmacists and technicians, who are dedicated to the science of pharmaceutical compounding. For healthcare providers requiring compounded medications for office use, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a trusted source.
To learn more about the specific compounded preparations available or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. Our facility is ready to assist with your medication needs. Reach us via our website at or by phone at (407)993-1381. We are located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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. This requires us to comply with current good manufacturing practices (cGMP) and federal standards for sterility testing, which are more comprehensive than those applied to traditional pharmacies.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy distributes compounded medications for office use to healthcare providers and practitioners. Individual patient prescriptions are handled by 503A compounding pharmacies. Our services are specifically for healthcare professionals at 2160 W State Road 434, Longwood, FL 32779.
3. What types of compounded medications are available from your facility?
503B Compounding Pharmacy produces large-scale batches of sterile injectables, ophthalmics, infusions, and other preparations that are commercially unavailable or in shortage. These are supplied to healthcare providers for use in their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How does 503B Compounding Pharmacy ensure the quality of its products?
Our facility at 2160 W State Road 434, Longwood, FL 32779 follows strict cGMP protocols. This includes rigorous environmental controls, extensive personnel training, validated cleaning and sterilization processes, and thorough testing of raw materials and finished products to ensure safety, potency, and sterility.
5. How can a healthcare provider at this location place an order?
Healthcare providers can place orders for compounded medications by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will assist with your specific requirements for medications needed at 2160 W State Road 434, Longwood, FL 32779.