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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to producing high-quality compounded medications for office use by healthcare practitioners. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP), ensuring that every preparation meets the highest standards of purity, potency, and sterility.
The core mission of 503B Compounding Pharmacy is to provide healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with a reliable and compliant source for medications that are often in short supply or unavailable from conventional manufacturers. Our services are specifically designed for office-based administration, supporting physicians, surgeons, dermatologists, and other medical providers in delivering optimal patient care. We operate on a larger scale than traditional compounding pharmacies, allowing us to supply medications in bulk quantities without patient-specific prescriptions, which is essential for clinic and surgical settings.
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 experienced pharmacists and technicians. We specialize in the compounding of sterile preparations, including injectables, infusions, ophthalmics, and other critical medications. Every batch we produce undergoes stringent testing and quality control procedures to ensure its safety and efficacy before it is released for distribution. This commitment to quality provides healthcare practitioners with the confidence they need when using our products.
By choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, healthcare providers gain a trusted partner in pharmaceutical sourcing. We help mitigate drug shortages, reduce the administrative burden of in-office compounding, and ensure a consistent supply of essential medications. Our team is committed to responsive service, timely delivery, and strict adherence to all federal regulations governing 503B outsourcing facilities.
For more information about our services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. Reach us by phone at (407)993-1381 or visit our website at . Our facility is dedicated to serving the specific needs of the medical community at 2160 W State Road 434, Longwood, FL 32779.
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 in compliance with Section 503B of the FD&C Act. We are subject to federal oversight and must adhere to strict current good manufacturing practices (cGMP) for the production of compounded human drugs for office use by healthcare practitioners.
2. Who can order medications from 503B Compounding Pharmacy?
Our services are exclusively for healthcare practitioners and facilities. We supply compounded medications for office use; we do not fulfill prescriptions for individual patients. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can order medications for use in their clinical practice.
3. What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in sterile compounded preparations. This includes injectables, intravenous (IV) bags, ophthalmics, and other medications that are administered in a clinical setting. All products are prepared in bulk quantities under cGMP standards.
4. How does 503B Compounding Pharmacy ensure medication quality and safety?
Quality and safety are paramount. Our processes at 2160 W State Road 434, Longwood, FL 32779 include rigorous testing, environmental monitoring, and validation procedures as required by cGMP. Every batch of medication is quality-controlled before being released, ensuring it meets specified standards of identity, strength, quality, and purity.
5. How can I place an order or get more information?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly. You can call us at (407)993-1381 or visit our website at for more detailed information and to initiate the ordering process for our location at 2160 W State Road 434, Longwood, FL 32779.