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, providing medications for healthcare providers to administer to their patients in a professional clinical setting or for office use.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded drugs that are distributed to healthcare facilities. The medications prepared at our location on W State Road 434 are formulated without a patient-specific prescription and are intended for use by practitioners under the conditions set forth in Section 503B. This model supports hospitals, clinics, and other healthcare providers by ensuring they have access to essential medications that may be in shortage or are not commercially available. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which guarantees a level of quality, purity, and consistency beyond traditional compounding.
Our facility at 2160 W State Road 434 is equipped with state-of-the-art technology and maintained under stringent environmental controls to ensure the integrity of every preparation. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who are experts in aseptic processing and quality assurance. Every batch of medication is subjected to extensive testing and validation processes before it is released. This unwavering commitment to compliance and excellence makes 503B Compounding Pharmacy a trusted partner for the medical community in need of reliable compounded pharmaceutical products.
For more information about the services provided directly from our facility, please contact 503B Compounding Pharmacy. You can reach us via our website at or by phone at (407)993-1381. Our team is prepared to assist healthcare professionals with their 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 operates under Section 503B of the FD&C Act. This registration requires us to comply with current Good Manufacturing Practices (cGMP) and undergo regular FDA inspections, ensuring the medications we produce meet the highest standards for safety, quality, and purity.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy distributes compounded medications to healthcare facilities and practitioners for office use. Orders are placed by licensed healthcare providers, such as physicians, hospitals, and clinics, and are not dispensed directly to individual patients based on a patient-specific prescription from our location at 2160 W State Road 434.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in the large-scale compounding of both sterile and non-sterile medications. This includes preparations that address drug shortages, or medications that are not available from commercial manufacturers. All products are compounded in our facility located at 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality control process work at your facility?
Quality control is paramount. Every batch of medication produced at our location undergoes rigorous testing, including sterility testing, endotoxin testing, and potency assays, in accordance with cGMP standards. This ensures every product leaving our facility at 2160 W State Road 434 meets strict specifications for safety and efficacy.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. For ordering information and to discuss your specific needs, please contact us at (407)993-1381 or visit our website at . All operations and distributions are conducted from 2160 W State Road 434, Longwood, FL 32779.