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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practices (cGMP), which ensures every preparation meets stringent quality control standards before it is released for patient use.
The core mission of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, sterile and non-sterile compounded medications that are essential for patient care. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and maintained under controlled environmental conditions to ensure product integrity. Our highly trained team of pharmacists and technicians are dedicated to the precise and accurate preparation of medications, serving as a critical partner to local clinics, hospitals, and healthcare practitioners by providing them with the reliable medications their patients need.
By focusing on larger-scale compounding, 503B Compounding Pharmacy can provide medications that may be in short supply or discontinued by commercial manufacturers. This vital service helps to prevent treatment interruptions and supports the continuity of care for patients. Every batch produced within our facility undergoes extensive testing and quality assurance procedures, providing an unparalleled level of confidence to the medical community we serve directly from our location at 2160 W State Road 434, Longwood, FL 32779.
We invite healthcare providers to partner with us for their compounded medication needs. For more information about our services and capabilities, please contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website to learn more at https://503bcompoundingpharmacy.com/.
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 operates under Section 503B of the FD&C Act. We adhere to current Good Manufacturing Practices (cGMP), which are rigorous federal standards for quality control, testing, and production that exceed state-level pharmacy regulations.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers and institutions. We serve physicians, clinics, hospitals, and other healthcare entities that require compounded medications for their patients. Patients must obtain these medications through their prescribing healthcare professional.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in the preparation of both sterile and non-sterile compounded medications in larger batches. This includes medications that are on drug shortage lists or have been discontinued by commercial manufacturers, ensuring a consistent supply for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at your facility?
Quality is our highest priority. Every batch of medication prepared at our facility undergoes a stringent quality assurance process. This includes testing for sterility, potency, and endotoxins by our internal lab and independent third-party laboratories to ensure each preparation meets exact specifications before being released.
How can a healthcare provider start ordering from 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. Please call us at (407)993-1381 to speak with a representative who can discuss your needs, provide necessary documentation, and guide you through our ordering and credentialing process.