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 status means we are subject to rigorous federal oversight, including current Good Manufacturing Practices (cGMP), which ensures every batch of medication we produce meets stringent quality control specifications for strength, purity, and stability.
The services provided at our Longwood location are centered on the large-scale production of compounded sterile preparations (CSPs) for office use. We supply healthcare practitioners with essential medications that are often in short supply or unavailable from conventional manufacturers. By providing these critical drugs, we support local medical practices, surgical centers, and clinics in delivering continuous, high-quality patient care. Our portfolio includes a wide array of sterile injectables, ophthalmics, and other preparations necessary for various therapeutic applications.
Our operational model at 2160 W State Road 434 is designed for efficiency and reliability. We utilize state-of-the-art technology and controlled environments to ensure the integrity of every product. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists, technicians, and quality assurance professionals dedicated to upholding the principles of cGMP. This dedication ensures that every medication leaving our facility is of the highest possible quality, providing practitioners and their patients with confidence and peace of mind.
For healthcare providers seeking a dependable source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a trusted partner. We invite you to learn more about our services and how we can support your practice. Contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381 to speak with a representative.
FAQ
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 complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet heightened requirements for quality, purity, and strength.
2. Can I pick up medications directly from your location at 2160 W State Road 434?
No, 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Our services are designed to supply physicians, clinics, and hospitals. Patients should contact their healthcare provider, who can order from our facility.
3. What types of medications does 503B Compounding Pharmacy produce?
We specialize in compounding sterile preparations, including injectables, ophthalmics, and other medications that are often on drug shortage lists. Our focus is on providing bulk quantities for healthcare settings at our Longwood facility.
4. How does the quality control process work at your facility?
Our quality control at 2160 W State Road 434 is comprehensive. It includes rigorous testing, environmental monitoring, and strict adherence to cGMP protocols to ensure every batch of compounded medication is safe, pure, and potent before it is released.
5. How can a healthcare provider at a local clinic place an order with your pharmacy?
Healthcare providers can initiate an order by contacting 503B Compounding Pharmacy directly at (407)993-1381 or through the professional portal on our website at https://503bcompoundingpharmacy.com/. Our team will guide you through the ordering process.