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 large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, testing, and production, providing healthcare providers and patients with medications they can trust.
As a 503B outsourcing facility, our primary focus is on producing medications that are not commercially available or are in shortage. We serve the specific needs of healthcare practitioners by providing them with a reliable source for high-quality compounded preparations. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by a team of expert pharmacists and technicians who are rigorously trained in current Good Manufacturing Practices (cGMP). This ensures every preparation that leaves our pharmacy meets stringent standards for potency, purity, and sterility.
The services provided by 503B Compounding Pharmacy are distinct from traditional compounding. We operate on a larger scale, producing batches of medications for office use by healthcare providers. This allows physicians, surgeons, dermatologists, and other medical professionals in our community to have essential medications readily available for their patients. Our location at 2160 W State Road 434, Longwood, FL 32779 is a hub for quality and reliability, supporting the local medical community with critical pharmaceuticals.
We encourage healthcare providers and their staff to contact us to discuss their specific medication needs. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our team is committed to supporting the healthcare community from our facility at 2160 W State Road 434, Longwood, FL 32779 with the highest caliber of compounded medications.
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 complies with strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and testing for the medications we produce compared to a traditional pharmacy.
2. Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare providers. Physicians, clinics, hospitals, and other healthcare institutions can order medications from our location at 2160 W State Road 434, Longwood, FL 32779 for office use in treating their patients. We do not fulfill prescriptions directly from individual patients.
3. What types of medications does 503B Compounding Pharmacy produce?
We specialize in compounding sterile injectables, ophthalmics, and other preparations that are on the FDA drug shortage list or are not available from commercial manufacturers. Our focus at 2160 W State Road 434, Longwood, FL 32779 is on providing essential medications that are critical for patient care.
4. How does the quality assurance process work at your facility?
As a 503B outsourcing facility, we are required to perform rigorous quality assurance testing. This includes testing for sterility, endotoxins, potency, and stability on our compounded preparations. Every batch produced at 2160 W State Road 434, Longwood, FL 32779 undergoes this stringent process to ensure patient safety.
5. How can a healthcare provider place an order with your pharmacy?
Healthcare providers can initiate an order by contacting our facility directly. Please call us at (407)993-1381 to speak with our team about your specific needs. We will guide you through the process from our location at 2160 W State Road 434, Longwood, FL 32779.