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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies a commitment to the highest standards of quality, safety, and regulatory oversight, distinguishing it from traditional compounding pharmacies. The primary function of this outsourcing facility is to provide bulk quantities of compounded medications for office use by healthcare practitioners, ensuring a reliable and compliant source for patient-specific needs.
The services provided at the 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779 are defined by its operational classification. As an outsourcing facility, it compounds drugs without receiving patient-specific prescriptions, supplying these medications to hospitals, clinics, and physician offices for office stock. This model supports healthcare providers by ensuring vital medications, such as sterile injectables, ophthalmics, and other preparations, are readily available for administration to patients within their care. The facility's processes are governed by Current Good Manufacturing Practices (cGMP), which enforce rigorous protocols for sterility testing, potency verification, and overall product quality assurance.
Patients and healthcare providers utilizing the services of the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from a supply chain that prioritizes integrity and reliability. The medications produced are essential for a wide range of medical treatments and procedures, often involving formulations that are commercially unavailable or in shortage. By adhering to the stringent federal requirements mandated for 503B outsourcing facilities, this pharmacy provides an critical service to the local medical community, ensuring practitioners have access to high-quality compounded preparations for their patients.
For more information on the services available from this specific facility, please contact 503B Compounding Pharmacy directly. The team can be reached by phone at (407)993-1381. Detailed information about its operations and compliance is also available on its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this facility is a 503B outsourcing facility?
It means this facility is registered with the FDA under Section 503B and compounds medications in bulk for office use by healthcare practitioners. It operates under stricter federal standards, including Current Good Manufacturing Practices (cGMP), compared to a traditional compounding pharmacy.
Who can order medications from the 503B Compounding Pharmacy at 2160 W State Road 434?
Medications are supplied to healthcare practitioners and entities such as hospitals, clinics, and physician offices for use within their practice. This location does not compound medications based on individual patient prescriptions for the public.
What types of medications does this 503B Compounding Pharmacy produce?
The facility compounds a range of sterile and non-sterile preparations, including injectables, ophthalmics, and other formulations that are often on drug shortage lists or are not otherwise commercially available for healthcare providers.
How does the 503B Compounding Pharmacy ensure the quality of its medications?
Quality is ensured through strict adherence to cGMP guidelines, which mandate rigorous testing for sterility, potency, and purity. As an FDA-registered outsourcing facility, its processes and facilities are subject to federal inspection.
How can a healthcare provider at a local clinic place an order?
Healthcare providers interested in the services provided at 2160 W State Road 434, Longwood, FL 32779 should contact the facility directly to discuss ordering procedures. You can reach them by phone at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ for more information.