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/
Welcome to 503B Compounding Pharmacy, an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical compounding, providing sterile and non-sterile medications in bulk for healthcare facilities. The 503B Compounding Pharmacy designation signifies our commitment to a level of quality, safety, and regulatory oversight that goes beyond traditional compounding.
The primary distinction of a 503B Compounding Pharmacy like ours is our registration with the FDA. This registration requires compliance with Current Good Manufacturing Practices (cGMP), which are the same rigorous standards followed by conventional drug manufacturers. For the medical community we serve from our location at 2160 W State Road 434, this means every batch of medication we compound undergoes stringent quality control testing, including sterility and endotoxin testing for injectable products. This ensures that physicians, hospitals, and clinics can confidently administer our medications, knowing they meet exacting specifications for purity, potency, and safety.
Our services at 503B Compounding Pharmacy are tailored to meet the specific needs of healthcare providers. We specialize in the large-scale compounding of medications that are often in short supply or unavailable from standard pharmaceutical manufacturers. This includes essential preparations such as sterile injectables, ophthalmic solutions, and topical creams. By operating as a 503B outsourcing facility, we provide a reliable source for these critical medications, helping to mitigate drug shortages and ensure patient care remains uninterrupted for practitioners relying on our Longwood location.
The operational model of a 503B Compounding Pharmacy is fundamentally different from a traditional 503A pharmacy. While 503A pharmacies compound medications based on individual patient-specific prescriptions, our 503B facility compounds medications in larger batches without requiring individual prescriptions beforehand. These batches are then distributed to healthcare facilities for office use. This model is efficient for medical practices, surgical centers, and hospitals in need of a consistent, verified supply of compounded medications for their procedures and treatments.
Accessing the services of 503B Compounding Pharmacy at 2160 W State Road 434 is a streamlined process for qualified healthcare entities. Our team works directly with medical professionals to fulfill their bulk compounding needs. We encourage healthcare providers to explore our capabilities and place orders through our official channels. For detailed information about our current offerings and to initiate an order, please contact us directly.
To learn more or to speak with a representative, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381. 503B Compounding Pharmacy is dedicated to supporting the medical community with the highest quality compounded pharmaceuticals from our facility in Longwood.
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 must comply with Current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and batch testing for 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 facilities and practitioners for office use. This includes hospitals, clinics, and surgical centers. We do not dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy compound?
As a 503B outsourcing facility, we specialize in compounding sterile and non-sterile medications in bulk quantities. This often includes injectable medications, ophthalmic solutions, and other preparations that may be on shortage or are needed in larger volumes by healthcare providers.
How does the quality assurance process work at 503B Compounding Pharmacy?
Every batch of medication compounded at our facility undergoes rigorous quality control testing. This includes testing for sterility, potency, and endotoxins to ensure the final product meets all specified standards before it is released for distribution to healthcare providers.
How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities can place orders by contacting 503B Compounding Pharmacy directly. For more information and to initiate an order, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.