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 safe and precise preparation of compounded medications for specific patient needs. As a 503B outsourcing facility, we adhere to the highest standards of quality control, sterility, and potency, which are rigorously enforced by the FDA. This designation differentiates us from traditional compounding pharmacies and ensures that healthcare providers at our location can confidently prescribe our medications.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. These medications are prepared in advance of receiving a prescription and are based on the established needs of healthcare providers serving patients at 2160 W State Road 434, Longwood, FL 32779. Our services are essential for hospitals, clinics, and other healthcare entities that require a reliable, bulk supply of high-quality medications that may be commercially unavailable or in shortage. We provide a critical link in the healthcare supply chain for our local community.
Quality and safety are the foundational principles of everything we do at our facility. The 503B Compounding Pharmacy employs state-of-the-art technology and environmental controls to ensure every preparation meets exacting specifications. Our processes include rigorous testing, thorough documentation, and validation procedures as mandated by the FDA. This commitment to excellence provides healthcare professionals at our location with the assurance that the medications they administer are of the highest possible quality, safety, and efficacy.
By focusing on the specific needs of the medical community at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy helps to mitigate drug shortages and provides access to essential medications that are not otherwise available from commercial manufacturers. Our role is to support local healthcare providers, enabling them to offer the best possible care to their patients with reliable, FDA-registered compounded pharmaceutical products.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly at (407)993-1381. Our team is dedicated to supporting the healthcare community at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We operate under stricter federal regulations than a traditional pharmacy, which includes adhering to Current Good Manufacturing Practices (cGMP) for enhanced quality control, sterility assurance, and reporting.
2. Who can receive medications from 503B Compounding Pharmacy?
Our medications are prepared in bulk for healthcare providers and facilities. We supply hospitals, clinics, and other healthcare practitioners who serve patients at our location. We do not typically dispense medications directly to individual patients without a prescription from their provider.
3. What types of medications does 503B Compounding Pharmacy prepare?
We specialize in preparing both sterile and non-sterile compounded medications in larger quantities. This often includes solutions for injections, ophthalmics, and other preparations that are essential for healthcare providers at 2160 W State Road 434, Longwood, FL 32779, particularly those addressing drug shortages.
4. How does the quality control at a 503B facility differ?
As an FDA-registered 503B outsourcing facility, we are subject to routine FDA inspections and must comply with cGMP standards. This involves rigorous environmental monitoring, extensive testing of components and finished preparations, and validated processes to ensure every batch is pure, potent, and sterile if required.
5. How can a healthcare provider at this location place an order?
Healthcare providers and facilities at 2160 W State Road 434, Longwood, FL 32779 can initiate orders by contacting our facility directly at (407)993-1381. Our team will provide information on our available preparations and the ordering process.