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 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 the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare providers in our community with access to essential medications that are not commercially available. Our operations are distinct from traditional compounding pharmacies, as we operate on a larger scale and are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and routine FDA inspections.
The core mission of 503B Compounding Pharmacy is to support the local medical community by producing high-quality compounded medications in bulk for office use. This allows physicians, surgeons, hospitals, and clinics in the area to have critical medications readily available for their patients without the need for a patient-specific prescription to be presented prior to compounding. Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and maintained under strict environmental controls to ensure the sterility, potency, and purity of every preparation that leaves our laboratory.
Our team at the Longwood location consists of highly trained pharmacists, pharmacy technicians, and quality assurance professionals who are experts in the science of compounding. We specialize in the production of a wide array of dosage forms, including intravenous (IV) bags, ophthalmics, injectables, and other sterile preparations. Every batch of medication is subjected to extensive testing and quality control checks to verify its identity, strength, quality, and purity before it is released for distribution to healthcare practitioners serving patients from our facility.
503B Compounding Pharmacy is committed to being a reliable partner for the healthcare providers at 2160 W State Road 434, Longwood, FL 32779. We understand the critical need for accessible, safe, and effective medications. By focusing on bulk compounding under Section 503B, we help ensure that local medical practices can operate efficiently and effectively, providing their patients with the necessary treatments. For more information or to speak with our team, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
Being an FDA-registered outsourcing facility means our operation 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 Federal Food, Drug, and Cosmetic Act. This subjects us to federal oversight, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the medications we compound meet the highest standards for safety, quality, and purity.
2. Who can order medications from your facility at 2160 W State Road 434?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Our primary clients are physicians, surgeons, hospitals, clinics, and other healthcare entities that require bulk compounded medications for their practice. We do not compound medications for individual patients based on a direct prescription; instead, we supply medications to licensed practitioners for administration to their patients within their practice.
3. What types of medications do you compound at your Longwood location?
At our facility on W State Road 434, we specialize in compounding sterile preparations. This includes a range of medications such as intravenous (IV) solutions, injectables, ophthalmics, and other sterile products that are essential for healthcare providers. All compounding is performed under strict environmental controls to ensure sterility and patient safety.
4. How does the quality control process work at your pharmacy?
Quality control is paramount at our 503B outsourcing facility. Every batch of medication compounded at 2160 W State Road 434 undergoes rigorous testing and validation processes. This includes testing for sterility, potency, endotoxins, and particulate matter. Our quality assurance team meticulously documents every step of the compounding process to ensure full traceability and compliance with all regulatory standards.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We will guide you through the necessary steps, which include establishing an account and providing required documentation. You can reach our team by phone at (407)993-1381 or through our website at to discuss your specific medication needs and our ordering procedures.