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 signifies our commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We provide healthcare facilities with access to critical medications that may be in short supply or not commercially available, directly supporting patient care from our specific location.
The operations at 2160 W State Road 434 are built upon a foundation of rigorous quality control. As a 503B outsourcing facility, our processes are subject to current Good Manufacturing Practices (cGMP), ensuring every preparation is consistent, pure, and potent. This includes extensive environmental monitoring, validation of sterilization processes, and stringent testing of components and finished products. Healthcare providers at 2160 W State Road 434 can confidently utilize our services, knowing the medications are produced under the most scrupulous conditions to mitigate risk and enhance patient safety.
The core service of 503B Compounding Pharmacy is the production of medications in anticipation of receiving prescriptions, rather than in response to individual patient-specific prescriptions. This allows us to supply healthcare facilities with essential drugs, particularly those on the FDA drug shortage list, in ready-to-use formulations. Our portfolio includes a range of sterile preparations such as IV bags, ophthalmics, and injectables, as well as non-sterile compounds. By serving the needs of practitioners from our facility at 2160 W State Road 434, we act as a vital component in the local healthcare infrastructure, ensuring continuity of care.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical professionals. Our team works directly with healthcare facilities to understand their formulary needs and provide reliable, high-quality compounded medications. We encourage all inquiries and orders to be directed through our official channels. You can learn more about our specific services and compliance by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our facility directly at (407)993-1381. Our dedicated staff at 2160 W State Road 434, Longwood, FL 32779 is ready to provide the support and information you require.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. This subjects us to heightened regulatory standards, including compliance with current Good Manufacturing Practices (cGMP), mandatory FDA inspections, and adverse event reporting, ensuring a higher level of quality and safety for the medications we compound.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
As a 503B outsourcing facility, we provide medications to healthcare facilities and practitioners by prescription, not directly to individual patients. We supply our compounded preparations to entities such as hospitals, clinics, and surgical centers to support their patient care services from our location.
What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding both sterile and non-sterile medications. This includes a significant focus on preparations that are on national drug shortage lists, such as specific injectables, IV solutions, and ophthalmics, which are essential for ongoing medical treatments.
How does the quality control at 503B Compounding Pharmacy work?
Quality control is integral to our operations at 2160 W State Road 434. Our processes adhere to strict cGMP standards, which encompass environmental monitoring of our cleanrooms, validation of all equipment and sterilization methods, and rigorous testing of raw materials and finished products to ensure identity, strength, quality, and purity.
How can a healthcare facility at 2160 W State Road 434 place an order?
Healthcare facilities and practitioners can place orders by contacting our facility directly. For more information on our available products and to initiate the ordering process, please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to learn more about our specific services.