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 preparation of sterile and non-sterile compounded medications. The 503B designation signifies that our pharmacy adheres to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP). This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to a reliable source of high-quality compounded pharmaceutical products.
The primary function of a 503B outsourcing facility like ours is to compound medications in large batches for office use by healthcare practitioners. This model allows physicians, surgeons, and other medical professionals to have essential medications readily available for patient care without the need for in-office compounding. The medications prepared by 503B Compounding Pharmacy are intended for administration within a clinical setting, providing a critical component for various treatments and procedures performed at 2160 W State Road 434, Longwood, FL 32779.
As a 503B outsourcing facility, our operations are subject to rigorous oversight. We undergo regular inspections by the U.S. Food and Drug Administration to maintain our registered status. This level of regulation provides an additional layer of assurance for the healthcare community utilizing our services at 2160 W State Road 434, Longwood, FL 32779. The medications produced are made under stringent environmental controls and quality assurance testing protocols, which are hallmarks of the 503B compounding pharmacy model.
503B Compounding Pharmacy provides a vital service by compounding drugs that may be in short supply or unavailable from traditional manufacturers. This helps to mitigate drug shortages that can impact patient care. For healthcare providers at our location, this means a more consistent and dependable supply of necessary medications. The ability of a 503B outsourcing facility to prepare these vital drugs is a key benefit of partnering with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779.
Healthcare professionals seeking a trusted 503B outsourcing facility can connect with 503B Compounding Pharmacy to discuss their specific needs. Our team is equipped to provide information on our compounding capabilities and the quality standards we uphold. We invite inquiries from practitioners at 2160 W State Road 434, Longwood, FL 32779 to learn how our 503B compounding services can support their practice. For more detailed information, please visit our website at https://503bcompoundingpharmacy.com/ or contact us directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
Being an outsourcing facility means 503B Compounding Pharmacy is registered with the FDA under Section 503B of the FD&C Act. This registration signifies that our facility at 2160 W State Road 434, Longwood, FL 32779 complies with current Good Manufacturing Practices (cGMP) and is subject to federal oversight, ensuring a high standard of quality for the compounded medications we produce.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Our services are designed for physicians and other qualified healthcare professionals who require compounded medications for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does a 503B compounding pharmacy typically prepare?
As a 503B outsourcing facility, we compound a range of sterile and non-sterile medications, often including formulations that are on drug shortage lists or are not commercially available. The specific medications prepared by 503B Compounding Pharmacy are intended for use in a clinical setting.
How does the quality assurance at a 503B outsourcing facility differ from a traditional pharmacy?
503B Compounding Pharmacy operates under cGMP regulations, which are more rigorous than the standards applied to traditional compounding pharmacies. This includes extensive testing of components and finished products, stringent environmental monitoring, and validated processes to ensure sterility and potency for all medications prepared at 2160 W State Road 434, Longwood, FL 32779.
How can I contact 503B Compounding Pharmacy at your location?
You can contact 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381. Our facility is located at 2160 W State Road 434, Longwood, FL 32779.