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 means we adhere to the highest federal standards for quality control, sterility testing, and production, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is the production of medications that are not available commercially or are in shortage. Our operations at the Longwood facility are designed to support the needs of healthcare practitioners by providing bulk quantities of compounded medications. The 503B outsourcing facility status ensures that all medications produced within our facility are created under a rigorous quality framework that is consistently monitored and enforced.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a modern, purpose-built facility equipped with state-of-the-art technology to ensure the integrity and safety of every preparation. The environment is meticulously controlled, with ISO-classified cleanrooms where our highly trained compounding personnel prepare medications. Every step, from ingredient sourcing to final packaging, is governed by strict standard operating procedures and current good manufacturing practices (cGMP).
503B Compounding Pharmacy provides healthcare practitioners with access to essential medications that may be experiencing a national drug shortage or are no longer manufactured by large pharmaceutical companies. By fulfilling this vital need from our Longwood facility, we help ensure patient care continues without interruption. Our team works directly with practitioners, providing a reliable and quality-assured source for their compounded pharmaceutical needs.
For more information about the services provided by 503B Compounding Pharmacy from our facility at 2160 W State Road 434, Longwood, FL 32779, please contact us. You can reach us by phone at (407)993-1381 or visit our website to learn more: 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 complies with stricter federal standards for compounding, including current good manufacturing practices (cGMP), rigorous potency and sterility testing, and detailed reporting of adverse events.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications in bulk to healthcare practitioners and facilities. Patients receive these medications through their prescribing healthcare providers who source from our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
Our facility focuses on producing medications that are on the FDA drug shortage list or are not available from traditional commercial manufacturers. This includes a range of sterile injectables, ophthalmics, and other preparations essential for patient care, all compounded at our location on W State Road 434.
How does the quality control process work at your Longwood facility?
Quality control is integral to our operation. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes extensive testing for potency, sterility, and endotoxins before it is released, ensuring it meets all specified quality attributes and is safe for patient use.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team at the Longwood facility will provide information on ordering procedures, product availability, and fulfillment.