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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is precisely located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we adhere to the most rigorous federal standards for quality, safety, and production scale. This designation distinguishes our operations from traditional compounding pharmacies, as we produce large batches of compounded medications for office use by healthcare practitioners. Our mission is to provide physicians and clinics with access to high-quality, sterile and non-sterile compounded preparations that are essential for patient care.
The services provided by 503B Compounding Pharmacy at our location at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for the healthcare community. We compound medications that are often in shortage or are not commercially available, ensuring that medical professionals have the necessary tools for treatments, procedures, and therapies. Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and environmental controls to ensure every preparation meets strict sterility and potency specifications. The team at 503B Compounding Pharmacy consists of highly trained pharmacists and technicians who are dedicated to the science of compounding within the regulatory framework of a 503B outsourcing facility.
For healthcare providers seeking a reliable source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to excellence and compliance. We operate under current Good Manufacturing Practices (cGMP), which mandates rigorous testing, quality control, and extensive documentation. This ensures that every vial, syringe, or vial leaving our facility is of the highest possible quality. Our presence at 2160 W State Road 434 supports the local medical community by providing a dependable, domestic source for critical medications, reducing reliance on international supply chains and mitigating drug shortage issues.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare professionals can learn more about our available formulations and processes by visiting our website at https://503bcompoundingpharmacy.com/. To speak directly with a representative regarding orders or specific compounding needs, you can contact us at (407)993-1381. The team at our facility at 2160 W State Road 434, Longwood, FL 32779 is ready to assist with your requirements, ensuring you receive the compounded preparations necessary for your practice.
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 Section 503B of the FD&C Act. This requires us to follow current Good Manufacturing Practices (cGMP) for large-scale compounding, which includes rigorous testing, quality control, and adherence to strict sterility standards for medications produced for office use.
Who can purchase medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides compounded medications exclusively to healthcare practitioners for office use. Our services are designed for physicians, clinics, and other healthcare facilities. Medications are not dispensed directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we compound preparations that are often on the drug shortage list or are not commercially available. This includes a range of sterile injectables, ophthalmics, and other formulations required by healthcare providers for procedures and treatments administered within their practice at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at your facility?
Quality assurance is paramount at our location at 2160 W State Road 434, Longwood, FL 32779. Every batch of medication undergoes extensive testing for sterility, potency, and endotoxins. Our processes are documented in strict compliance with cGMP regulations to ensure the safety and efficacy of every product we compound.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting our facility directly. For more information on our products and to discuss your specific needs, please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our team at 2160 W State Road 434, Longwood, FL 32779 will guide you through the ordering process.