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. We serve healthcare providers and their patients by producing sterile and non-sterile preparations that are not commercially available, ensuring specific patient needs are met with precision and care.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under rigorous quality control protocols. As a 503B outsourcing facility, our processes are subject to current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This ensures that every preparation leaving our facility meets stringent standards for potency, purity, and sterility. Healthcare professionals can confidently prescribe our compounded medications, knowing they are sourced from a fully compliant and audited facility dedicated to patient safety.
Our service at this location is defined by our ability to compound medications in larger volumes for office use. Physicians and practitioners in need of readily available, pre-made compounded preparations for their practice can rely on our 503B Compounding Pharmacy. This eliminates the need for individual patient-specific prescriptions for certain standard preparations, allowing for greater efficiency in clinical settings. We provide healthcare providers with access to a consistent and reliable supply of high-quality compounded drugs.
The team at our Longwood facility comprises skilled pharmacists and technicians who are experts in the science of compounding. Their dedication is focused on the precise execution of formulas and the meticulous preparation of each drug. We utilize advanced technology and equipment within our 2160 W State Road 434 facility to ensure accuracy and sterility in every batch we produce. Our primary goal is to support the medical community by being a trusted partner in patient care.
For more information about our services or to place an order, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance standards at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and follows strict current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet the highest federal standards for safety, quality, and purity.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare providers. Physicians and other qualified medical practitioners can order compounded medications from our location at 2160 W State Road 434 for office use to treat their patients.
Can I as a patient pick up my medication directly from your facility?
No. As a 503B outsourcing facility, we distribute compounded medications to healthcare providers and practices, not directly to patients. Your prescribing provider will administer or dispense the medication to you from their office.
What types of medications does 503B Compounding Pharmacy prepare?
We compound a range of sterile and non-sterile preparations in batches at our Longwood facility. This includes medications for hormone therapy, pain management, ophthalmology, and other therapeutic areas where commercially available products are not suitable.
How do I contact 503B Compounding Pharmacy to place an order or ask a question?
Healthcare providers can contact our facility directly by calling (407)993-1381. You can also find more information about our services and compliance on our website at https://503bcompoundingpharmacy.com/.