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 at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to compound large quantities of sterile and non-sterile medications without receiving patient-specific prescriptions. This regulatory distinction allows us to provide healthcare facilities with access to essential medications that are often in short supply or unavailable from conventional manufacturers. Our primary mission is to support the local medical community by delivering high-quality, compounded preparations that meet rigorous federal quality standards.
The operations at our Longwood location are fundamentally different from a traditional 503A compounding pharmacy. As a 503B outsourcing facility, we are subject to Current Good Manufacturing Practices (cGMP), which are the same stringent standards required of major pharmaceutical manufacturers. This includes extensive environmental testing, rigorous validation of all processes and equipment, and thorough sterility testing on every batch of compounded sterile preparations. Our commitment to cGMP ensures that every medication leaving our facility at 2160 W State Road 434, Longwood, FL 32779 is of the highest possible quality, purity, and consistency.
We specialize in the production of injectable medications, particularly those used in hospital and clinical settings. This includes IV bags, syringes, and other sterile preparations that are critical for patient care. Our state-of-the-art cleanroom at our Longwood facility is a controlled environment where air quality, temperature, and humidity are constantly monitored to prevent contamination. Highly trained personnel, following exacting aseptic techniques, compound each batch to ensure patient safety. By providing these vital medications, we help ensure that healthcare providers at local institutions have the reliable supplies they need.
While our primary function is outsourcing for healthcare facilities, the medications we produce directly impact patient care within the community. The reliability of our supply chain helps prevent treatment delays and supports positive health outcomes. Our team of pharmacists and quality assurance professionals is dedicated to upholding the strictest protocols at our location on W State Road 434. For more information on our services or to discuss your facility's needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered entity that compounds medications in accordance with Section 503B of the FD&C Act. This means our facility at 2160 W State Road 434, Longwood, FL 32779 operates under Current Good Manufacturing Practices (cGMP) and can provide compounded medications to healthcare facilities without requiring individual prescriptions.
2. Who can receive medications from the 503B Compounding Pharmacy location?
Medications compounded at our facility on W State Road 434 are primarily distributed to healthcare facilities like hospitals, clinics, and surgical centers. These entities then administer the medications to their patients under their care within their own practices.
3. What types of medications are compounded at the Longwood location?
Our 503B outsourcing facility in Longwood specializes in compounding sterile injectable preparations. This includes a wide range of medications such as IV bags, epidurals, pain management injections, and other solutions that are essential for institutional healthcare settings.
4. How does the 503B Compounding Pharmacy ensure medication quality and safety?
Our facility adheres to strict cGMP standards. This involves rigorous testing of raw materials, environmental monitoring of our cleanrooms, validation of all sterilizing equipment, and end-product sterility testing on every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare facility place an order with your pharmacy?
Healthcare facilities interested in our services can initiate the process by contacting our team directly. You can reach us by phone at (407)993-1381 or visit our website at to learn more and discuss your specific compounding needs.