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 preparation of sterile and non-sterile compounded medications. The 503B designation signifies that our pharmacy adheres to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP). This regulatory framework ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779, have access to a reliable source of compounded medications for their patients when an FDA-approved drug is not suitable.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. As an outsourcing facility, we compound medications without receiving patient-specific prescriptions. Instead, we prepare medications in larger batches for healthcare facilities to keep in stock for future patient needs. This model is essential for providing essential drugs, such as sterile injectables, that may be in shortage. The team at our location on W State Road 434 is comprised of skilled pharmacists and technicians who utilize advanced technology and rigorous testing protocols to ensure the potency, purity, and sterility of every preparation that leaves our facility.
Healthcare professionals relying on 503B Compounding Pharmacy can be confident in the integrity of the supply chain. Our commitment is to support the medical community by providing high-quality compounded preparations that meet specific clinical requirements. The services provided at 2160 W State Road 434, Longwood, FL 32779, are integral to patient care, offering solutions when standard treatment options are unavailable. We maintain transparent operations and welcome inquiries about our processes and compliance standards.
For comprehensive information about 503B Compounding Pharmacy, please visit our website at https://503bcompoundingpharmacy.com/. To speak directly with a representative, please call (407)993-1381. Our facility is focused on serving the needs of the healthcare community from our location at 2160 W State Road 434, Longwood, FL 32779.
FAQ
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
Being an outsourcing facility under Section 503B means 503B Compounding Pharmacy is registered with the FDA and complies with current Good Manufacturing Practices (cGMP). This allows us to compound medications in batches for healthcare facilities without requiring individual prescriptions, ensuring a consistent supply of critical drugs from our location at 2160 W State Road 434, Longwood, FL 32779.
Who can order from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides compounded medications to healthcare facilities and practitioners, such as hospitals, clinics, and physician offices. We do not dispense medications directly to individual patients from our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in preparing sterile and non-sterile compounded medications, often focusing on formulations that are on drug shortage lists or are otherwise unavailable from standard manufacturers. All preparations are made under strict quality controls at our facility on W State Road 434.
How does 503B Compounding Pharmacy ensure medication quality and safety?
Quality and safety are paramount at 503B Compounding Pharmacy. Our processes at 2160 W State Road 434, Longwood, FL 32779, include rigorous testing, environmental monitoring, and adherence to cGMP standards to verify the sterility, stability, and potency of every batch of compounded medications we produce.
How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities can initiate orders by contacting 503B Compounding Pharmacy directly. For more information on ordering and our available preparations, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.