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 is 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 rigorous current good manufacturing practices (cGMP) to produce sterile and non-sterile compounded medications in large batches for healthcare providers. This model allows us to supply physician offices, hospitals, and clinics with high-quality medications that are not readily available from traditional pharmaceutical manufacturers.
The operations at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding pharmacies. Our 503B status signifies a higher level of federal oversight and quality control. We compound medications based on patient-specific needs when commercial products are unavailable, but we do so on a larger scale, which can improve efficiency and accessibility for healthcare providers. The medications produced at our 503B Compounding Pharmacy are essential for a wide range of medical treatments, including office-administered injectables, hormone replacement therapies, and other critical care solutions.
Healthcare professionals who partner with our facility at 2160 W State Road 434, Longwood, FL 32779 benefit from a reliable source for compounded medications. Our 503B Compounding Pharmacy is equipped with state-of-the-art technology and staffed by experienced professionals dedicated to maintaining the highest standards of safety and potency. Every batch produced undergoes stringent testing and quality assurance protocols to ensure that the medications meet precise specifications. This commitment to quality at our Longwood location provides peace of mind to practitioners and their patients.
Our primary focus is on serving the medical community by providing essential medications that are often in short supply or discontinued by larger manufacturers. By operating as a 503B outsourcing facility, we help bridge gaps in the pharmaceutical supply chain. The team at 2160 W State Road 434, Longwood, FL 32779 works diligently to ensure timely delivery and consistent quality, supporting the vital work of local healthcare providers. For more information about our services or to discuss your needs, please contact us directly.
To learn more about the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds medications under stricter federal regulations and current good manufacturing practices (cGMP) than a traditional pharmacy.
Who can receive medications from the 503B Compounding Pharmacy?
Our 503B Compounding Pharmacy primarily supplies medications to healthcare providers and facilities. Patients receive these medications through their physician's office or clinic, not directly from our location at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does the 503B Compounding Pharmacy produce?
We produce a range of sterile and non-sterile compounded medications in batches, including injectables and other formulations, for healthcare providers. The specific medications compounded at 2160 W State Road 434, Longwood, FL 32779 are those that are on shortage or not commercially available.
How does the 503B Compounding Pharmacy ensure medication quality?
As an FDA-registered 503B outsourcing facility, we follow rigorous cGMP standards at our location on 2160 W State Road 434, Longwood, FL 32779. This includes extensive testing, environmental monitoring, and quality control procedures for every batch of medication we compound.
How can a healthcare provider place an order with the 503B Compounding Pharmacy?
Healthcare providers can contact our facility directly at 2160 W State Road 434, Longwood, FL 32779 to discuss their needs. Please call (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on ordering.