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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is precisely 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, our 503B status means we adhere to rigorous current good manufacturing practices (cGMP) and are subject to regular FDA inspections. This ensures that every batch of medication we produce for healthcare providers meets stringent federal requirements for strength, quality, purity, and identity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. Our services are designed to support healthcare providers at 2160 W State Road 434, Longwood, FL 32779 by providing access to medications that may be in shortage or are not commercially available. We compound a significant volume of medications in advance of receiving a prescription, which allows for immediate distribution to local practitioners, thereby enhancing patient care and treatment outcomes. Our operations are critical for hospitals, clinics, and other healthcare entities that require a reliable, compliant source for essential medications.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a dedicated team of pharmacists, chemists, and quality assurance professionals. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This unwavering focus on quality control and sterility assurance is fundamental to our mission. We provide healthcare professionals with the confidence that the medications they administer are safe, effective, and produced under the most controlled conditions possible.
503B Compounding Pharmacy is an essential partner for the local medical community. By focusing on the specific needs of providers at our location, we help ensure that patients receive the critical treatments they need without delay. For more information about our services or to discuss your needs, please contact us directly. Visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
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 operates in compliance with Section 503B of the FD&C Act. We are held to current good manufacturing practice (cGMP) standards, which are more rigorous than the standards applied to traditional compounding pharmacies, ensuring a higher level of quality and safety control for the medications we produce.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers and facilities. We do not dispense medications directly to individual patients. Our services are designed to supply physicians, hospitals, and clinics with compounded medications for their office use or for administration to patients within their care at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, including injectables, ophthalmics, and other formulations that require an aseptic environment. We also compound non-sterile medications. Our focus is often on drugs that are on shortage or are not available from commercial manufacturers.
How does 503B Compounding Pharmacy ensure medication quality and sterility?
Our facility employs a comprehensive quality assurance program that includes rigorous environmental monitoring, validated sterilization processes, and extensive testing of both components and finished products. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 is made in compliance with strict cGMP protocols to ensure sterility, potency, and purity.
How can a healthcare provider at this location place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We encourage you to visit our website at https://503bcompoundingpharmacy.com/ for more detailed information or to call us at (407)993-1381 to speak with a representative who can discuss your specific needs and our ordering procedures.