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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the large-scale compounding of sterile and non-sterile medications. We adhere to the most stringent federal quality and safety standards, providing healthcare practitioners with access to high-quality compounded pharmaceutical products that are not otherwise commercially available.
As a 503B outsourcing facility, our operations are distinct from traditional compounding pharmacies. We are subject to Current Good Manufacturing Practice (cGMP) regulations and undergo regular FDA inspections. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets rigorous standards for potency, purity, and sterility. Our mission is to support the local medical community by serving as a reliable source for essential medications, including office-use preparations for physician offices, hospitals, and healthcare clinics.
The services provided by 503B Compounding Pharmacy at our Longwood location are designed for healthcare providers. We compound a significant volume of injectable medications, ophthalmics, and other dosage forms that are critical for patient care. By outsourcing their compounding needs to our 503B facility, healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can be confident in the quality and consistency of the medications they administer, allowing them to focus on their primary objective: patient health and well-being.
Our team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in the art and science of pharmaceutical compounding. We utilize state-of-the-art equipment and technology within our controlled environment to ensure the integrity of every batch. For healthcare providers seeking a trusted 503B outsourcing facility partner at 2160 W State Road 434, Longwood, FL 32779, we are the local resource for compliant, high-quality compounded medications.
To learn more about the services offered by 503B Compounding Pharmacy or to place an order, please contact us. Website: | Phone: (407)993-1381. We are proud to serve the healthcare community from our facility 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 compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. We operate under Current Good Manufacturing Practice (cGMP) regulations, which are the strict quality standards required for mass-produced pharmaceuticals, ensuring a higher level of oversight for potency, sterility, and purity.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our 503B outsourcing facility provides medications primarily for healthcare practitioners and entities for "office-use." This means our clients are typically physicians, surgeons, hospitals, and clinics located at 2160 W State Road 434, Longwood, FL 32779 who administer medications on-site to their patients. We do not typically dispense medications directly to individual patients without a prescription.
3. What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in compounding sterile preparations, including injectables, ophthalmics, and other formulations that are not available off-the-shelf from commercial manufacturers. Our services at 2160 W State Road 434, Longwood, FL 32779 focus on providing these medications in larger quantities for healthcare provider administration.
4. How does the quality assurance process work at your facility?
As a 503B outsourcing facility, our quality assurance process is extensive. It includes rigorous testing of ingredients, environmental monitoring of our cleanrooms, validation of sterilization processes, and thorough documentation and testing of finished preparations. This comprehensive system, mandated by federal law, ensures every product that leaves 2160 W State Road 434, Longwood, FL 32779 meets exacting quality standards.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their specific medication needs and to place an order. Our team will guide you through the process. You can reach us at our facility located at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or through our website at .