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 practitioners with access to medications that may be in shortage, discontinued, or otherwise unavailable for their patient care needs. By producing these essential medications in bulk, we offer a reliable and consistent supply chain for clinics, hospitals, and other healthcare entities. The medications produced at our facility on W State Road 434 are created under a prescription drug order for an individual patient, further supporting the critical work of local medical professionals.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced environmental controls and ISO-classified cleanrooms to ensure the sterility and potency of our preparations. Our team of highly trained pharmacists and technicians utilizes precision equipment and validated processes to compound a wide array of medications. This operational scale and commitment to cGMP standards allow us to achieve a level of quality control and consistency that is essential for patient safety. We are dedicated to upholding the trust placed in us by the medical community through our unwavering focus on compliance and excellence from our Longwood facility.
For healthcare providers seeking a dependable source for high-quality compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434 stands as a pivotal resource. We encourage you to learn more about our capabilities and compliance standards. You can reach us by phone at (407)993-1381 for any inquiries or to discuss your specific needs. Comprehensive information about our services and regulatory status is also available on our website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. 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. We are subject to federal oversight, including adherence to current Good Manufacturing Practices (cGMP) and routine FDA inspections, which ensures a higher level of quality control and consistency for the medications we compound.
2. Can I as an individual patient pick up my medication directly from your location?
No. 503B Compounding Pharmacy operates as an outsourcing facility that provides medications to healthcare facilities and practitioners, not directly to individual patients. Your healthcare provider will order the medication from us and then administer or dispense it to you through their practice or clinic.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in the large-scale compounding of both sterile and non-sterile medications. This often includes medications that are on shortage or have been discontinued by commercial manufacturers, providing a critical supply for healthcare providers in the area.
4. How does the quality control at your facility differ from a traditional pharmacy?
As a 503B outsourcing facility, we are required to comply with cGMP regulations. This involves rigorous testing of components, validated sterilization processes, environmental monitoring of our cleanrooms, and extensive documentation for every batch produced at our Longwood location, ensuring a level of quality and safety that surpasses traditional pharmacy compounding standards.
5. How can a healthcare provider at your location order from 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will provide information on our available medications, ordering process, and compliance documentation. More details are also available on our website at https://503bcompoundingpharmacy.com/.