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. As a 503B outsourcing facility, we adhere to the highest standards of current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous quality and safety protocols for the healthcare providers we serve.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are distributed for office use by healthcare practitioners. The medications prepared at our 2160 W State Road 434 location are provided to physicians, clinics, hospitals, and other healthcare entities for administration to their patients within their practice settings. This model allows healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to maintain an inventory of essential medications without the burden of in-house compounding, ensuring they have access to critical drugs that may be in shortage or not commercially available.
Our services at 2160 W State Road 434, Longwood, FL 32779 are defined by our regulatory designation. We provide a reliable source of high-quality compounded pharmaceuticals, including hormone replacement therapy (HRT), ophthalmics, injectables, and other sterile preparations. Each batch is produced under a system of strict quality control, including stability testing and endotoxin testing, to guarantee potency and purity. The operations at 503B Compounding Pharmacy are subject to regular FDA inspections, providing an additional layer of assurance for the medical community at 2160 W State Road 434, Longwood, FL 32779.
Healthcare professionals seeking a trusted partner for their compounding needs can rely on the expertise and regulatory compliance of 503B Compounding Pharmacy. We are committed to supporting the local medical community by providing safe, effective, and consistently prepared medications. For more information on our services or to place an order, please contact us directly. Reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/.
FAQ
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 strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and consistency for the medications we compound compared to traditional pharmacies.
Can I as an individual patient pick up my prescription directly from 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy operates as an outsourcing facility that provides medications for office use by healthcare providers. Individual patient prescriptions are typically dispensed by the healthcare provider's office after they have obtained the medication from our facility. Patients should contact their healthcare provider directly.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 typically prepare?
Our facility specializes in compounding sterile injectables, hormone replacement therapies (HRT), ophthalmics, and other medications that are often on drug shortage lists or are not available from commercial manufacturers. All preparations are made for healthcare providers to administer within their practice.
How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your facility?
Healthcare providers and their authorized staff can place orders directly with 503B Compounding Pharmacy by calling (407)993-1381. Our team will guide you through the ordering process and provide any necessary documentation.
Why would a healthcare provider choose 503B Compounding Pharmacy at 2160 W State Road 434?
Healthcare providers choose our facility for our commitment to quality, regulatory compliance, and reliability. We provide a vital service by compounding medications that are in short supply or unavailable, allowing practices to continue treating their patients without interruption, supported by the assurance of FDA oversight and cGMP standards.