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, utilizing rigorous testing and beyond-use dating to ensure the safety, potency, and purity of every preparation that leaves our pharmacy.
The core function of a 503B outsourcing facility is to compound medications on a larger scale than a traditional pharmacy, supplying these vital preparations to healthcare practitioners for office use and to other healthcare facilities. The team at our Longwood location is comprised of skilled pharmacists and technicians who are experts in the complex art and science of pharmaceutical compounding. We provide healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable source of high-quality compounded medications that are essential for patient care.
Our services are defined by our regulatory status. Operating under Section 503B means our facility is subject to current Good Manufacturing Practice (cGMP) regulations and is routinely inspected by the FDA. This provides an additional layer of safety and assurance for the healthcare providers we serve. We compound a significant volume of medications, which allows us to provide consistent, readily available products to support the medical community at our specific location.
For healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 seeking a trusted partner for their compounded pharmaceutical needs, 503B Compounding Pharmacy offers a dependable and quality-focused solution. We are committed to supporting local patient care through our specialized compounding services. You can reach our facility directly at (407)993-1381 or learn more about our regulatory standards and capabilities by visiting our website at .
FAQ
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We compound large batches of medications for office use by healthcare providers and must comply with stringent federal standards, including current Good Manufacturing Practices (cGMP), which are different from the standards applied to traditional 503A pharmacies.
2. Can I, as a patient, pick up my prescription directly from your location?
No. As a 503B outsourcing facility, we provide compounded medications to healthcare providers and healthcare facilities for "office use." Your prescribing provider at 2160 W State Road 434, Longwood, FL 32779 would order the medication from us and then administer or dispense it to you directly from their practice.
3. How does the quality control at a 503B outsourcing facility benefit me?
The medications compounded at our Longwood facility undergo rigorous testing for sterility, potency, and endotoxins as required by cGMP regulations. This extensive quality control process provides an added layer of safety and assurance for the medications that your healthcare provider uses in your treatment.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our FDA-registered outsourcing facility specializes in preparing both sterile and non-sterile compounded medications. This includes a wide range of preparations such as injectables, ophthalmics, and topicals that are supplied to healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare provider at this location place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their specific needs, place an order, or speak with our compounding specialists. We serve the medical community operating from 2160 W State Road 434, Longwood, FL 32779.