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.
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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving our facility meets stringent federal requirements for strength, quality, purity, and identity.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. Our location at 2160 W State Road 434, Longwood, FL 32779 serves local medical practices, hospitals, clinics, and other healthcare providers. We compound preparations that are often on the FDA drug shortage list or are not available from conventional manufacturers, ensuring that practitioners have the necessary medications to treat their patients without interruption. Our services are essential for supporting the local healthcare infrastructure by providing reliable access to critical medications.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed for large-scale compounding in a controlled environment. We utilize advanced technology and rigorous testing protocols, including sterility testing and endotoxin testing, to guarantee the safety and efficacy of our preparations. The team at 503B Compounding Pharmacy consists of highly trained pharmacists and technicians who are experts in the science of compounding. We are committed to excellence, providing healthcare professionals with a trusted source for high-quality, compounded medications for their office use.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779 seeking a dependable partner for their medication needs, 503B Compounding Pharmacy is the premier choice. We invite you to contact us to learn more about our services and how we can support your practice. You can reach us via our website at or by phone at (407)993-1381.
FAQ
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 and must comply with Current Good Manufacturing Practices (cGMP), which involve rigorous standards for production, testing, and quality control to ensure patient safety.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our primary clients are healthcare practitioners and institutions. We provide compounded medications for office use to medical practices, hospitals, surgical centers, and clinics. We do not typically dispense medications directly to individual patients without a prescription from their provider for office administration.
3. What types of medications does 503B Compounding Pharmacy prepare?
We prepare a wide range of sterile and non-sterile compounded medications, with a focus on drugs that are currently on the FDA’s drug shortage list or are not commercially available from pharmaceutical manufacturers. This ensures a continuous supply of essential medications for healthcare providers at our location.
4. How does the quality assurance process work at your facility?
Quality assurance is paramount at our 2160 W State Road 434 location. Every batch of medication undergoes extensive testing, including sterility, endotoxin, potency, and stability testing, as required by cGMP regulations. This process verifies the identity, strength, quality, and purity of all preparations before they are released.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly. You can reach our team by phone at (407)993-1381 to discuss your specific needs and our available preparations. Our website also provides information for potential clients.