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. This designation signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, this facility provides a critical service by producing medications that are not commercially available, thereby addressing specific patient needs as determined by healthcare providers. The 503B outsourcing facility model is distinct from traditional compounding, as it involves larger-scale production of compounded sterile preparations (CSPs) in advance of or without receiving a patient-specific prescription, adhering to rigorous FDA current Good Manufacturing Practices (cGMP).
The core function of 503B Compounding Pharmacy is the sterile compounding of medications. This process is performed in a controlled environment with stringent air quality, cleanliness, and sterility assurance protocols to minimize the risk of contamination. The highly skilled team of pharmacists and technicians at the 2160 W State Road 434 location utilizes state-of-the-art technology and equipment to ensure the accuracy, potency, and purity of every preparation. By operating under Section 503B, this pharmacy provides healthcare facilities, including hospitals, clinics, and physician offices, with access to essential medications that may be in short supply or discontinued by major manufacturers. This service is vital for patient care, ensuring that medical professionals have the necessary tools for treatment protocols.
Patients and healthcare providers who utilize the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from a reliable source of high-quality compounded medications. The pharmacy’s operations are subject to regular FDA inspections, providing an additional layer of oversight and confidence. The team is dedicated to supporting the local medical community by providing products that meet specific clinical requirements, ultimately contributing to positive patient outcomes. For more information or to inquire about services, please contact 503B Compounding Pharmacy directly.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 2160 W State Road 434, Longwood, FL 32779
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. This requires us to adhere to strict current Good Manufacturing Practices (cGMP) for higher-risk compounding, undergo regular FDA inspections, and report adverse events, ensuring a superior level of quality and safety for our compounded medications.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications primarily to healthcare facilities and practitioners for office use, rather than directly to individual patients. Healthcare professionals at practices located near 2160 W State Road 434, Longwood, FL 32779 can order these medications for administration to patients within their clinical setting.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in the large-scale compounding of sterile preparations, such as injectables, ophthalmics, and other medications that must be prepared in an aseptic environment. These are often medications that are on drug shortage lists or are not available from conventional manufacturers.
How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers and facilities can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, product availability, and delivery options for services at our Longwood location.
Why would a healthcare provider choose a 503B outsourcing facility?
Healthcare providers choose 503B Compounding Pharmacy at 2160 W State Road 434 for a reliable supply of high-quality, compounded sterile medications that meet rigorous federal standards. This is essential for ensuring patient safety, especially when using medications for office-based procedures or treatments that require drugs not available through standard commercial channels.