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 control, current good manufacturing practices (cGMP), and rigorous testing protocols mandated by federal law. This ensures that every preparation leaving our pharmacy meets stringent specifications for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are distributed to healthcare providers for office use. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians. We provide healthcare professionals with access to critical medications that may be in shortage or not commercially available, thereby supporting the continuity of patient care. The operations at this facility are focused on producing formulations that are beyond the scope of traditional 503A compounding pharmacies.
Our services at 2160 W State Road 434, Longwood, FL 32779 are defined by our regulatory status as a 503B outsourcing facility. This includes the compounding of injectables, ophthalmics, and other sterile preparations in large batches. Each batch is subject to thorough testing and quality assurance review before being released. The 503B Compounding Pharmacy provides these medications to practitioners within the legal framework established for outsourcing facilities, ensuring reliability and compliance for the medical community we serve directly from our Longwood location.
Patients and prescribers can be assured of the quality and safety of medications compounded at our FDA-registered facility. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 maintains a robust quality management system. For more information or to inquire about our services, please contact 503B Compounding Pharmacy at our phone number: (407)993-1381, or visit our website at . Our team is prepared to assist healthcare providers with their specific medication needs.
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 specific federal regulations under Section 503B. This requires us to follow current good manufacturing practices (cGMP), undergo regular FDA inspections, and provide medications for office use to healthcare practitioners.
2. Can I as a patient pick up a prescription directly from 2160 W State Road 434, Longwood, FL 32779?
No. As a 503B outsourcing facility, our primary operation is to compound large batches of medications for distribution to physicians, hospitals, and clinics for office use. Patients should receive their medications directly from their healthcare provider, not from our facility location.
3. What types of medications does 503B Compounding Pharmacy prepare at its Longwood facility?
At our location on W State Road 434, we specialize in compounding sterile preparations, including injectables and ophthalmics. These are often medications that are on drug shortage lists or are not otherwise available from commercial manufacturers, produced for healthcare providers to administer to patients in a clinical setting.
4. How does the quality assurance process work at your facility?
Our 503B outsourcing facility in Longwood implements a comprehensive quality program aligned with cGMP. Every batch of compounded medication undergoes rigorous testing for sterility, potency, and endotoxins by our quality control unit before it is released for distribution, ensuring the highest level of patient safety.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their needs and place an order. Our team at the Longwood facility will provide information on available formulations, ordering procedures, and distribution details.