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 federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality control benchmarks for the healthcare providers and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. Our operations are designed to provide healthcare facilities with access to essential drugs that may be in shortage or are not commercially available. By preparing these medications in advance and in larger batches, we provide a critical service that enhances patient care and supports the operational efficiency of local medical practices. The medications produced at our 2160 W State Road 434 facility are created under a prescription drug manufacturing license, guaranteeing a level of consistency and reliability that is vital for patient safety.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779, is equipped with advanced environmental control systems, including ISO-classified cleanrooms. These controlled environments are meticulously monitored to ensure the sterility and potency of our compounded preparations. Every step of our process, from ingredient sourcing to final packaging, is governed by robust quality assurance protocols. Our team of highly trained pharmacists and technicians leverages this technology and these strict procedures to deliver products that healthcare professionals can trust implicitly for their patients in our community.
503B Compounding Pharmacy provides a vital link in the healthcare supply chain for the local medical community. We work directly with physicians, hospitals, and clinics, enabling them to access high-quality compounded medications without the burden of in-house preparation. Our presence at 2160 W State Road 434 ensures that these essential services are readily available, supporting the health and well-being of the community we are dedicated to serving. For more information or to inquire about our services, 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, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the highest quality and safety standards for our compounded medications.
Who can receive medications from 503B Compounding Pharmacy?
Our medications are typically distributed to healthcare providers and facilities, such as hospitals, clinics, and physician offices, based on their patient needs. We operate on a bulk compounding model rather than fulfilling individual patient prescriptions directly from the public. Patients interested in our medications should consult their healthcare provider.
What types of medications does 503B Compounding Pharmacy prepare?
At our facility on 2160 W State Road 434, we specialize in the large-scale compounding of both sterile injectable and non-sterile medications. This often includes preparations that are on drug shortage lists or are not otherwise available from commercial manufacturers, providing a critical supply for local healthcare delivery.
How does 503B Compounding Pharmacy ensure the quality of its products?
Quality is assured through strict adherence to cGMP regulations. This involves rigorous testing of ingredients, environmental monitoring of our ISO-classified cleanrooms, validated sterilization processes, and comprehensive end-product testing to ensure sterility, potency, and stability for all medications produced at our Longwood location.
How can a healthcare facility at 2160 W State Road 434 order from 503B Compounding Pharmacy?
Healthcare facilities and providers can initiate orders or learn more about our available formulations by contacting our facility directly. You can reach us by phone at (407)993-1381 or visit our website for more information at https://503bcompoundingpharmacy.com/ to discuss your specific needs.