Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
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 compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, an FDA-registered 503B outsourcing facility undergoes rigorous federal oversight, ensuring that every preparation meets exacting standards for sterility, potency, and purity. We provide these medications for office use by healthcare practitioners, enabling them to have essential drugs readily available for their patients.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs). Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to support this mission with advanced environmental controls, including ISO-classified cleanrooms. Our highly trained staff of pharmacists and technicians adheres to strict aseptic techniques and robust quality control protocols. Every batch is meticulously prepared and tested to ensure it is free of contaminants and accurately dosed. This process provides healthcare providers with a reliable and trusted source for critical medications, from injectables to ophthalmic solutions.
Healthcare professionals who utilize the services of 503B Compounding Pharmacy can do so with complete confidence. Our operations are transparent and fully compliant with all current good manufacturing practices (cGMP). We provide our clients with easy access to certificates of analysis and other documentation for every batch of medication we produce. By choosing our facility at 2160 W State Road 434, Longwood, FL 32779, medical practices, hospitals, and clinics can streamline their inventory, reduce their compounding burden, and enhance patient care with consistently high-quality pharmaceutical products. We are a pivotal partner in the local healthcare ecosystem.
To learn more about our services or to place an order for your practice, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381. For comprehensive information about our compliance, available formulations, and the specifics of operating as a 503B outsourcing facility, we invite you to visit our website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 complies with strict federal standards for compounding medications on a larger scale. We operate under Section 503B of the FD&C Act, which subjects us to heightened regulations regarding current good manufacturing practices (cGMP), unlike traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Our medications are prepared for office use and are available for order by licensed healthcare practitioners. This includes physicians, surgeons, veterinarians, and other qualified medical professionals for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy prepare?
We specialize in the compounding of sterile preparations, such as injectables, infusions, ophthalmics, and other formulations that require an aseptic environment. Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped to produce these medications in batches for healthcare provider use.
How does 503B Compounding Pharmacy ensure medication safety and quality?
Safety and quality are paramount at our location. We achieve this through a multi-faceted approach that includes ISO-classified cleanrooms, rigorous environmental monitoring, validated processes, and comprehensive testing. Every batch produced at 2160 W State Road 434, Longwood, FL 32779 is tested for sterility, potency, and endotoxins to ensure it meets all specifications.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place an order by calling our facility directly at (407)993-1381. Our team will assist with the ordering process, answer any questions about available formulations, and provide necessary documentation. More information is also available on our website at https://503bcompoundingpharmacy.com/.