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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that our patients and healthcare providers receive medications of consistent and reproducible quality, batch after batch.
At our location on 2160 W State Road 434, we specialize in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. Our services are integral to supporting the medical community by providing essential medications that are not commercially available, such as those experiencing drug shortages or those requiring specific formulations not offered by major pharmaceutical manufacturers. The 503B Compounding Pharmacy provides a critical link in the healthcare chain, ensuring that practitioners have access to the necessary medications to treat their patients effectively.
The operations at 2160 W State Road 434 are built upon a foundation of advanced technology and pharmaceutical expertise. Our state-of-the-art cleanrooms are designed to meet or exceed ISO classifications, ensuring the sterility and integrity of all compounded preparations. Every process, from ingredient sourcing to final product testing, is meticulously controlled and documented. Our team of qualified pharmacists and technicians are highly trained in aseptic techniques and cGMP protocols, guaranteeing that every vial, syringe, and bottle that leaves our facility meets the strictest specifications for potency, purity, and stability.
We serve healthcare providers who require bulk compounded medications for their practice at 2160 W State Road 434. Our role is to empower these providers by alleviating the compounding burden from their offices, allowing them to focus on patient care. By outsourcing their compounding needs to our 503B facility, practitioners can be confident they are utilizing products that have undergone stringent quality control testing, including sterility testing, endotoxin testing, and potency assays. This level of assurance is a cornerstone of our service at 2160 W State Road 434.
For healthcare providers seeking a reliable source for high-quality compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434 stands as a trusted partner. We encourage you to learn more about our capabilities and current offerings. You can reach us by phone at (407)993-1381 or visit our website at . Our team is dedicated to supporting the local medical community with uncompromising quality and service.
FAQ
1. What does it mean that this is a 503B outsourcing facility at 2160 W State Road 434?
It means our facility is registered with the FDA under Section 503B of the FD&C Act. This subjects us to federal oversight and strict compliance with current Good Manufacturing Practices (cGMP), ensuring the medications we compound for office use meet the highest standards for safety, quality, and purity.
2. Can I, as a patient, pick up a prescription directly from your location at 2160 W State Road 434?
No. As a 503B outsourcing facility, our primary function is to compound medications in bulk for office use by healthcare practitioners. Patients receive their medications directly from their prescribing provider, not from our facility location.
3. What types of medications does the 503B facility at this location compound?
Our facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications, often focusing on formulations that are on drug shortage lists or are not commercially available. This includes various injectables, ophthalmics, and other preparations needed by healthcare providers for their practices.
4. How does the quality control process work at your Longwood location?
Every batch of medication compounded at 2160 W State Road 434 undergoes a rigorous quality control process. This includes testing for sterility, potency, endotoxins, and beyond-use dating validation by our in-house quality control department to ensure every product meets its specified standards before being released.
5. How can a healthcare provider at 2160 W State Road 434 place an order with your facility?
Healthcare providers can contact our facility directly to discuss their compounding needs and place an order. We can be reached by phone at (407)993-1381. Our team will provide information on ordering procedures, available formulations, and delivery options for this location.