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 to ensure the safety, potency, and purity of every preparation that leaves our pharmacy.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded drugs for office use by healthcare practitioners. We provide physicians, surgeons, hospitals, and clinics with access to essential medications that are not commercially available or are in shortage. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology, including ISO Class 7 cleanrooms, to produce sterile preparations like injectables, ophthalmics, and irrigations. This allows healthcare providers to obtain critical medications without the burden of in-house compounding, ensuring patient safety and streamlining their operational efficiency.
Our services are defined by our regulatory status as a 503B outsourcing facility. This designation means our operations are subject to FDA oversight, mandatory reporting of adverse events, and routine FDA inspections. For the medical community we serve from our location at 2160 W State Road 434, Longwood, FL 32779, this translates to an unparalleled level of confidence in the medications they administer to their patients. We provide a reliable source for compounded medications that are essential for various medical procedures and treatments, all produced under a framework of the most stringent federal regulations.
503B Compounding Pharmacy is committed to supporting the local healthcare infrastructure. By ensuring a consistent supply of high-quality, compounded medications from our facility at 2160 W State Road 434, Longwood, FL 32779, we enable healthcare providers to focus on patient care. Our role is to be a trusted partner in the medical supply chain, providing products that meet specific clinical needs and uphold the highest standards of pharmaceutical science.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at . Our facility is located 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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This subjects us to federal oversight, routine inspections, and strict compliance with current good manufacturing practices (cGMP) to ensure the highest quality and safety standards for our compounded medications.
2. Can I, as an individual patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy primarily prepares medications for office use by healthcare practitioners. Our facility at 2160 W State Road 434, Longwood, FL 32779 supplies medications to physicians, clinics, and hospitals, who then administer them to patients within their practice. We do not typically dispense medications directly to individual patients.
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 producing sterile compounded preparations. This includes injectables, ophthalmics, irrigations, and other medications that are often used in hospital and clinical settings, particularly those that are on shortage or not available from commercial manufacturers.
4. How does a healthcare provider place an order with your pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. Our team at 2160 W State Road 434, Longwood, FL 32779 can be reached by phone at (407)993-1381. We will work with your practice to fulfill your requirements for compounded medications.
5. Why would a healthcare provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Healthcare providers choose a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 because of the enhanced level of regulatory oversight and quality assurance. Our adherence to cGMP standards, rigorous testing, and FDA registration provides a greater guarantee of product sterility, potency, and safety, which is crucial for medications administered to patients in a clinical setting.