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 in pharmaceutical compounding. We serve healthcare providers by producing medications that are not commercially available, thereby fulfilling specific patient needs directly from our location on W State Road 434.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare practitioners. The medications prepared at our Longwood facility are distributed to hospitals, clinics, and physician offices for use when a prescriber determines that an FDA-approved drug is not appropriate for a patient's specific medical need. Our operations 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 meets stringent standards for potency, purity, and sterility.
By operating as a 503B outsourcing facility, we provide a critical service to the local medical community. Healthcare professionals in need of compounded medications for their practice can rely on our Longwood location for a consistent and reliable supply. Our team of highly skilled pharmacists and technicians utilizes state-of-the-art technology and equipment within our modern facility to compound a wide array of preparations. This allows prescribers to access essential medications without the logistical challenges of in-office compounding, ensuring they can focus on patient care.
Patients ultimately benefit from the services provided by 503B Compounding Pharmacy. When a physician utilizes a medication compounded at our facility, patients receive a product made under the most exacting quality controls. Our work supports personalized treatment plans and helps address drug shortages by providing alternative formulations. The entire operation is centralized at our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, ensuring a secure and monitored supply chain for essential medications.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website for additional details at https://503bcompoundingpharmacy.com/. Our facility is dedicated to supporting healthcare providers and improving patient outcomes through exceptional pharmaceutical compounding.
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 compounds medications in accordance with Section 503B of the FD&C Act. We adhere to current Good Manufacturing Practices (cGMP), which are rigorous quality standards enforced by the FDA for drug manufacturers.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility are intended for office use by healthcare practitioners. We provide medications to hospitals, clinics, and physician offices located in Longwood and the surrounding community. Patients receive these medications directly from their healthcare provider.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we compound a broad range of sterile and non-sterile medications that are not available commercially. This includes various formulations to meet specific clinical needs, all produced under strict quality controls at our location on W State Road 434.
How does a healthcare provider order from 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting our facility directly. For ordering information and requirements, providers are encouraged to call our main line at (407)993-1381 to speak with a representative.
Where is 503B Compounding Pharmacy located?
Our FDA-registered outsourcing facility is physically located at 2160 W State Road 434, Longwood, FL 32779. This is our only location, and all our compounding services are provided from this address.