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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to essential drugs that may be in short supply or not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of medications in an environment of unparalleled quality control. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 adheres to Current Good Manufacturing Practices (cGMP), which are the same rigorous standards followed by major pharmaceutical manufacturers. This involves stringent testing of all incoming components, meticulous environmental monitoring of our cleanrooms, and robust sterility assurance protocols for all injectable preparations. Every batch of medication is compounded with precision and undergoes rigorous quality checks before it is released, providing healthcare professionals with absolute confidence in the medications they administer.
By operating as a 503B outsourcing facility, 503B Compounding Pharmacy addresses critical drug shortages that can impact patient care at 2160 W State Road 434, Longwood, FL 32779. We compound a significant volume of medications, including essential sterile injectables, ophthalmics, and other formulations that are on the FDA drug shortage list. This vital service helps to ensure continuity of care and allows healthcare providers to maintain their treatment protocols without interruption. Our team of highly skilled pharmacists and technicians is dedicated to providing a reliable source of high-quality compounded medications for the medical community we serve directly from our location.
503B Compounding Pharmacy provides its services exclusively to healthcare providers and does not dispense medications directly to individual patients. Our mission is to be a trusted partner to physicians, clinics, hospitals, and other healthcare entities by supplying them with the necessary medications for office use. We encourage healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 to explore how our services can support their practice. For more detailed information about our capabilities or to initiate an order, please contact us directly via our website at https://503bcompoundingpharmacy.com/ or by phone 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 complies with strict federal standards, including Current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and oversight compared to a traditional pharmacy.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to licensed healthcare providers for office use. We do not dispense medications directly to individual patients. Healthcare professionals can order medications for their practice located at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
We specialize in compounding a wide range of sterile and non-sterile medications, including many that are currently on the FDA drug shortage list. This includes sterile injectables, ophthalmics, and other formulations that may not be readily available from commercial manufacturers.
How does 503B Compounding Pharmacy ensure medication sterility and quality?
Our facility at 2160 W State Road 434, Longwood, FL 32779 employs rigorous cGMP protocols. This involves advanced environmental monitoring, validated sterilization processes, and comprehensive testing of both raw materials and finished products to ensure every batch meets exacting standards for potency, purity, and sterility.
How can a healthcare provider at this location place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly to discuss their needs and initiate the ordering process. You can reach us by visiting our website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381.