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 compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that our processes and products meet an elevated level of consistency and reliability.
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare providers. Our primary mission is to support the medical community by providing bulk compounded preparations that are essential for patient care. The services provided by 503B Compounding Pharmacy are integral to hospitals, clinics, and physician practices, ensuring they have access to vital medications that may be commercially unavailable or in short supply.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted within a state-of-the-art facility designed to prevent contamination. Our sterile compounding suites are equipped with advanced environmental controls, including ISO-classified air quality, to ensure the integrity of every preparation. Every step, from ingredient sourcing to final packaging, is meticulously documented and controlled under our robust quality assurance program. This unwavering dedication to quality at our Longwood location guarantees that healthcare professionals receive medications they can trust for their patients.
503B Compounding Pharmacy provides a critical service from our facility at 2160 W State Road 434, Longwood, FL 32779. We compound preparations that are often on the FDA drug shortage list, helping to alleviate critical gaps in the pharmaceutical supply chain. By working directly with healthcare providers, we ensure a consistent and reliable source of essential medications. For more information about our services or to speak with our team, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
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. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring a higher level of quality control and consistency for compounded medications compared to traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are designed for healthcare providers and institutions. Medications compounded at our Longwood facility are typically distributed for "office use" to licensed practitioners, including physicians, surgeons, and clinics, who then administer them to patients within their practice setting.
Can individual patients pick up prescriptions directly from your location?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications in bulk to healthcare providers. Individual patient prescriptions are dispensed by the ordering healthcare provider from their office, not directly from our facility at 2160 W State Road 434, Longwood, FL 32779.
How does the quality control process work at your Longwood facility?
Our quality control at 2160 W State Road 434 is comprehensive. It includes rigorous testing of ingredients, environmental monitoring of our cleanrooms, validation of all equipment and processes, and thorough sterility testing of finished products to ensure every preparation meets strict cGMP standards before it is released for distribution.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our team directly. We encourage providers to visit our website at https://503bcompoundingpharmacy.com/ for more details or to call us at (407)993-1381 to discuss their specific needs and establish an account.