Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and reporting, providing a critical service to the local medical community.
The core function of 503B Compounding Pharmacy is to produce medications in bulk for physicians, clinics, hospitals, and other healthcare providers serving patients from its facility at 2160 W State Road 434. This model allows healthcare professionals at their local practices to access essential medications without the burden of in-house compounding, ensuring they can focus on patient care. The medications produced are not dispensed directly to individual patients from this location but are instead supplied to licensed practitioners for administration within their professional practice settings.
Operating from 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility is equipped with state-of-the-art cleanrooms and utilizes advanced technology to ensure the sterility, potency, and purity of every preparation. The pharmacy’s compliance with Current Good Manufacturing Practices (cGMP) is a fundamental aspect of its operation, guaranteeing that every batch of medication meets stringent FDA-mandated quality assurance protocols. This includes rigorous environmental monitoring, finished product testing, and stability studies.
The team at 503B Compounding Pharmacy comprises highly skilled pharmacists and technicians who are experts in the science of compounding. Their expertise ensures that healthcare providers in the area have reliable access to a consistent supply of high-quality medications. For any inquiries regarding services or to place an order, healthcare entities can contact 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility? It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We compound large volumes of sterile and non-sterile medications for office use by healthcare practitioners and must comply with strict federal quality and safety standards, including Current Good Manufacturing Practices (cGMP).
2. Can I, as an individual patient, pick up a prescription at your location? No. 503B Compounding Pharmacy supplies medications exclusively to licensed healthcare practitioners and facilities for office use. Individual patients do not receive prescriptions directly from our location at 2160 W State Road 434. Your healthcare provider will administer the medication we compound within their practice.
3. How do I place an order as a healthcare provider? Healthcare providers can place orders for compounded medications by contacting our facility at 2160 W State Road 434, Longwood, FL 32779 directly. You can call us at (407)993-1381 to speak with our team or visit https://503bcompoundingpharmacy.com/ for more information on our ordering process.
4. What kind of quality controls are in place at your facility? Our 503B outsourcing facility at 2160 W State Road 434 operates under cGMP guidelines. This involves extensive testing of components and finished products, validated sterilization processes, continuous environmental monitoring of our cleanrooms, and comprehensive documentation for every batch we compound to ensure patient safety.
5. Are the medications you compound FDA-approved? While the individual active ingredients we use are often FDA-approved drug substances, the specific compounded formulations we prepare at 2160 W State Road 434 are not individually approved by the FDA. However, our entire facility and its processes are subject to FDA oversight and inspection as a registered 503B outsourcing facility.