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 traditional compounding. We provide these critical pharmaceutical preparations to healthcare providers, ensuring they have access to the specific medications their patients need.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available. This includes creating formulations without non-essential allergens like dyes or preservatives, adjusting dosages to meet unique patient requirements, or compounding a medication that is currently on shortage or discontinued by major manufacturers. By operating as a 503B outsourcing facility, our processes are subject to rigorous FDA oversight, which includes current Good Manufacturing Practice (cGMP) regulations. This ensures every preparation that leaves our facility at 2160 W State Road 434, Longwood, FL 32779 meets definitive standards for potency, purity, and sterility.
Our services are specifically designed for healthcare professionals. We work directly with prescribers and clinics to supply them with compounded medications for office use, ensuring they have the necessary preparations on hand for immediate patient care. The medications prepared at our Longwood facility are integral to various treatment plans, supporting physicians, dermatologists, ophthalmologists, and other specialists in providing personalized care. Our location at 2160 W State Road 434 is a hub for reliable, high-quality pharmaceutical compounding.
For healthcare providers seeking a trusted partner in patient care, 503B Compounding Pharmacy offers a dependable source for compounded medications. We encourage you to learn more about our capabilities and how we can support your practice. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more detailed information.
FAQ
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 oversight for the sterility, potency, and quality of the medications we compound compared to a traditional pharmacy.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare professionals and facilities for office use or administration to their patients. We do not fulfill prescriptions directly from individual patients. Healthcare providers in need of compounded medications can contact us to establish an account.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile and non-sterile preparations that are not available commercially. This includes medications for hormone therapy, pain management, dermatology, ophthalmology, and other specialties, particularly those on national drug shortage lists.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will guide you through the process of setting up an account and submitting orders for the specific compounded medications your practice requires.
Where is 503B Compounding Pharmacy located?
503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. This is our only location, and all our compounding services are provided from this specific FDA-registered facility.