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. As a 503B outsourcing facility, we adhere to the highest current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous standards for sterility, potency, and purity. This designation differentiates us from traditional compounding pharmacies and provides an elevated level of assurance for healthcare providers and their patients.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. This service is essential for healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 who require ready-to-administer medications for their practice. We provide these practitioners with access to a consistent and reliable supply of high-quality medications that are often on shortage or unavailable from conventional pharmaceutical manufacturers. By supplying medications for office use, we support the efficient operation of medical practices and enhance patient care.
Our services at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for healthcare providers. We work directly with physicians, surgeons, and other medical professionals to supply the necessary medications for their procedures and treatments. The medications prepared by 503B Compounding Pharmacy are not intended for individual patient dispensing with a prescription to take home, but rather for immediate administration within the clinical setting. This focus allows us to specialize in bulk compounding and maintain the stringent controls required for this level of production.
The facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists and technicians. Every process, from ingredient sourcing to final packaging, is conducted under controlled environmental conditions and is subject to extensive quality control testing. This meticulous approach guarantees that every preparation leaving our facility is of the highest possible quality and safety. Healthcare providers can confidently utilize our products, knowing they are sourced from a trusted, FDA-registered 503B outsourcing facility.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779 seeking a dependable source for office-use medications, 503B Compounding Pharmacy is the premier choice. We invite you to learn more about our capabilities and how we can support your practice. You can reach us by phone at (407)993-1381 or visit our website at . Our team is ready to assist with your compounding needs and provide the reliable service you require.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility? It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. We follow current good manufacturing practices (cGMP) for the large-scale production of compounded sterile preparations, which involves rigorous testing and quality control standards beyond those of a traditional pharmacy.
2. Can I as an individual patient get a prescription filled at your location? No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. We do not compound medications based on individual patient prescriptions for take-home use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 order and administer our preparations within their practice settings.
3. Who can place an order with 503B Compounding Pharmacy? Orders are placed directly by healthcare providers and medical practices. Our services are designed for physicians, surgeons, and other qualified medical professionals who require compounded sterile preparations for use in their procedures and treatments at 2160 W State Road 434, Longwood, FL 32779.
4. What kinds of medications do you compound? As a 503B outsourcing facility, we specialize in compounding sterile preparations, including injectables, ophthalmics, and other medications that require sterility. We often compound medications that are currently on drug shortage lists from the FDA, providing a critical supply for healthcare providers at our location.
5. How do I contact your facility to discuss services? You can contact 503B Compounding Pharmacy directly by calling (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is available to answer questions from healthcare providers regarding our available preparations, ordering process, and compliance documentation. You can also visit our website at .