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 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, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring that every batch of medication we produce meets stringent federal requirements for strength, quality, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare facilities. Our operations at 2160 W State Road 434, Longwood, FL 32779 are specifically designed to support hospitals, clinics, surgery centers, and other healthcare providers by providing them with a reliable, compliant source for essential medications. By outsourcing their compounding needs to our 503B facility, healthcare providers can mitigate risks, reduce compounding burdens on their staff, and ensure patient access to critical drugs that may be in short supply or not commercially available.
Our services are defined by our operational model as a 503B outsourcing facility. We specialize in the batch compounding of medications, which are then distributed to healthcare providers for office use. This means we prepare significant quantities of medications in advance, based on anticipated need, allowing for immediate availability. The medications produced at our Longwood location are created in a controlled, sterile environment by our team of highly trained pharmacists and technicians, utilizing state-of-the-art equipment and validated processes to guarantee consistency and sterility in every vial, syringe, and bag.
503B Compounding Pharmacy provides a vital service for the healthcare community by addressing drug shortages. When a commercially manufactured drug goes on backorder or is discontinued, our facility can often compound a necessary alternative, helping to prevent interruptions in patient care. Our team works diligently to source high-quality active pharmaceutical ingredients (APIs) and components to create these essential preparations. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and the medical professionals they serve can depend on us for a consistent supply of crucial medications.
Engaging with 503B Compounding Pharmacy is a streamlined process for healthcare providers. Orders are placed directly with our facility for office-use medications, which are not intended for individual patient-specific prescriptions in the traditional pharmacy sense. Instead, we supply medications that a healthcare provider will keep on hand to administer to patients within their practice. For any inquiries regarding our services, to place an order, or to discuss your facility's specific needs, please contact us directly. We are here to serve the healthcare community from our location at 2160 W State Road 434, Longwood, FL 32779.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B of the FD&C Act. We compound large batches of sterile medications for office use by healthcare providers and must comply with stringent federal manufacturing standards, including Current Good Manufacturing Practices (cGMP).
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare facilities and providers, such as hospitals, clinics, and surgical centers. We supply medications for office use, meaning a healthcare professional administers them directly to a patient within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not fulfill individual patient prescriptions directly to the public.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile injectable medications. This includes a wide range of preparations used in various medical specialties, such as anesthesia, pain management, and antibiotics, all produced under cGMP standards at our location on W State Road 434.
How does 503B Compounding Pharmacy help with drug shortages?
When FDA-approved drugs are in shortage or unavailable, our facility can often compound a necessary alternative. Healthcare providers serving 2160 W State Road 434, Longwood, FL 32779 can rely on us to provide a compliant and steady supply of these critical medications to ensure continuous patient care.
How do I place an order or get more information?
Healthcare providers and facilities can contact 503B Compounding Pharmacy directly to place orders or discuss needs. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information about our services and compliance.