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. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. As a 503B outsourcing facility, this 503B Compounding Pharmacy adheres to rigorous current good manufacturing practices (cGMP), which are the same standards followed by conventional pharmaceutical manufacturers. This ensures a level of quality, sterility, and consistency that is paramount for patient safety.
The core mission of this 503B Compounding Pharmacy is to provide healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable and high-quality supply of essential medications. The 503B Compounding Pharmacy prepares these medications in advance of receiving a patient-specific prescription, allowing for immediate availability. This is a critical service for clinics, hospitals, surgical centers, and other healthcare providers who require certain medications on hand for urgent or routine procedures. The 503B Compounding Pharmacy's operations are subject to regular FDA inspections, providing an additional layer of oversight and assurance for its clients. By centralizing the compounding process under these strict controls, the 503B Compounding Pharmacy helps mitigate the risks associated with smaller-scale compounding while enhancing efficiency for local medical practices.
The product portfolio of this 503B Compounding Pharmacy includes a wide array of sterile preparations. These are essential medications used in various medical settings, including anesthesia, pain management, ophthalmology, and critical care. Every batch produced by the 503B Compounding Pharmacy undergoes extensive testing and quality control checks to verify potency, sterility, and purity. The team at the 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in aseptic technique and cGMP compliance. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B Compounding Pharmacy means outsourcing their compounding needs to a trusted, regulated entity, thereby saving valuable time and resources while guaranteeing the highest standard of care for their patients.
Engaging with the 503B Compounding Pharmacy is a streamlined process. Healthcare providers can place orders directly through the 503B Compounding Pharmacy. The dedicated team at the 503B Compounding Pharmacy is committed to providing responsive service and support to meet the dynamic needs of the medical community at 2160 W State Road 434, Longwood, FL 32779. For more detailed information about its services and capabilities, or to initiate an order, please contact the 503B Compounding Pharmacy directly at (407)993-1381 or visit its official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare practitioners. This 503B Compounding Pharmacy operates under strict federal cGMP standards, ensuring a higher level of regulatory oversight for sterility and quality compared to a traditional 503A pharmacy.
2. Who can order medications from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy provides medications exclusively to healthcare practitioners and facilities for office use. Orders are placed by physicians, clinics, hospitals, or surgical centers for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. This 503B Compounding Pharmacy does not fulfill prescriptions for individual patients.
3. What are the benefits of using a 503B Compounding Pharmacy for a medical practice?
Using this 503B Compounding Pharmacy ensures access to consistently high-quality, sterile medications without the need for in-house compounding. It saves time, reduces potential compounding errors, and provides assurance through FDA oversight and batch-level testing, allowing healthcare providers to focus on patient care.
4. How does the quality control process work at this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy adheres to current good manufacturing practices (cGMP). Every batch of compounded medication undergoes rigorous testing for sterility, potency, and endotoxins before it is released for distribution, providing a verifiable chain of quality and safety.
5. How can a healthcare provider at this location start ordering?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can contact the 503B Compounding Pharmacy directly to establish an account. You can reach the 503B Compounding Pharmacy by phone at (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/ to learn more about the ordering process and available formulations.