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 is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are distinct from traditional compounding pharmacies. We engage in the large-scale, non-patient-specific compounding of sterile and non-sterile medications. These medications are intended for office use by healthcare practitioners, enabling them to have essential drugs readily available for their patients. Our operations are subject to rigorous FDA standards, including current Good Manufacturing Practices (cGMP), which ensures the highest level of quality, sterility, and potency in every preparation we dispense.
The primary function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is to provide healthcare providers with access to critical medications that may be in shortage or are not commercially available. We supply physician offices, hospitals, and clinics with these vital preparations. Our status as a 503B outsourcing facility means we can compound medications in larger volumes before receiving a prescription, which is essential for emergency kits, surgical suites, and other clinical settings where immediate access to specific medications is required. This model supports the local medical community by providing a reliable, quality-assured source for these necessary drugs.
Quality and safety are the cornerstones of our operation at 2160 W State Road 434, Longwood, FL 32779. Our facility undergoes regular and stringent FDA inspections to maintain our registered outsourcing facility status. Every batch of medication we produce is tested for potency, sterility, and endotoxins to ensure it meets all specified standards before it is released. This unwavering commitment to cGMP protocols provides healthcare professionals with the confidence that the medications they receive from 503B Compounding Pharmacy are of the highest quality and safety for their patient care needs.
Healthcare providers seeking a dependable partner for their office-use medication needs can rely on 503B Compounding Pharmacy. We encourage you to contact our team to discuss how our services can support your practice. You can reach us at our facility located at 2160 W State Road 434, Longwood, FL 32779. For more information, please visit our website at or call us directly 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 complies with Section 503B of the FD&C Act. We adhere to current Good Manufacturing Practices (cGMP) and are subject to federal oversight and routine inspections, ensuring the medications we compound for office use meet the highest standards for safety, quality, and sterility.
2. Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy supplies medications to healthcare practitioners for office use. This includes physicians, surgeons, clinics, and hospitals. We provide medications for administration to patients within a clinical setting and do not fulfill individual patient prescriptions directly from our location at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy provide?
As a 503B outsourcing facility, we compound a range of sterile and non-sterile medications that are often on drug shortage lists or are not commercially available. This includes preparations for anesthesia, pain management, electrolytes, and other injectables essential for healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779 and the surrounding medical community.
4. How does the quality assurance process work at your facility?
Every batch of medication compounded at our location is rigorously tested. Our quality control procedures include testing for sterility, potency, and endotoxins by our in-house lab and independent third-party laboratories. This ensures every product that leaves 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is safe and effective for patient use.
5. How can a healthcare provider place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific needs. Orders can be placed by calling our facility at (407)993-1381. Our team is available to provide information and support for all inquiries related to our compounding services at 2160 W State Road 434, Longwood, FL 32779.