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 every preparation leaving our facility meets stringent federal quality standards.
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 to healthcare providers for office use. Our core mission is to provide practitioners with access to high-quality, reliable compounded preparations that are essential for patient care. The medications produced at our FDA-registered outsourcing facility are crucial for a wide range of medical treatments and procedures administered in clinical settings.
The operations at 503B Compounding Pharmacy are built on a foundation of precision and quality assurance. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced technology and equipment to ensure the integrity of every preparation. Our processes are meticulously controlled and continuously monitored to guarantee sterility, potency, and purity. By adhering to cGMP guidelines, we provide an additional layer of safety and consistency that is critical for healthcare providers who rely on our products for their patients.
Healthcare professionals can confidently source their office-use medications from our 503B outsourcing facility. The preparations compounded at 2160 W State Road 434, Longwood, FL 32779 are produced in larger batches under a prescription drug manufacturer's license, providing a vital supply of essential drugs. Our team of highly trained pharmacists and technicians is dedicated to upholding the strict protocols required of an FDA-registered facility, ensuring that every product meets its labeled strength, purity, and quality.
To learn more about the services provided by our FDA-registered outsourcing facility, we invite you to contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 for any inquiries. Detailed information about our compliance and operations is also available on our official website at https://503bcompoundingpharmacy.com/. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the medical community with uncompromising quality and reliability.
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 FDA and operates under Section 503B of the FD&C Act. We are subject to federal oversight and must comply with current Good Manufacturing Practice (cGMP) regulations, which ensures a higher level of quality and safety control for the compounded preparations we produce.
Who can order medications from your facility at 2160 W State Road 434?
Our 503B outsourcing facility provides compounded medications for office use to healthcare practitioners. These medications are intended for administration to patients within a clinical setting and are not dispensed directly to individual patients at our location.
What is the primary difference between a 503B outsourcing facility and a traditional pharmacy?
The primary difference is the scale of production and regulatory oversight. Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds medications in larger batches for office use under a manufacturer's license and must comply with strict FDA cGMP standards, whereas traditional compounding pharmacies typically compound on a smaller, patient-specific basis under state pharmacy law.
How does the 503B designation ensure the quality of the medications?
The 503B designation requires our facility to adhere to rigorous cGMP standards, which include stringent testing of components, validated processes, environmental monitoring, and thorough record-keeping. This comprehensive quality framework ensures the safety, identity, strength, quality, and purity of all preparations made at our location.
How can a healthcare provider get more information or place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381. Additional information about our capabilities and compliance is available on our website at https://503bcompoundingpharmacy.com/.