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
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP) to ensure the quality, safety, and potency of every preparation. Our primary focus is on producing medications in larger batches for healthcare providers, hospitals, and clinics, which distinguishes our role from traditional compounding pharmacies. We serve as a critical component in the healthcare supply chain, providing practitioners with access to essential medications that may be in shortage or not commercially available.
The team at 503B Compounding Pharmacy comprises highly skilled pharmacists, pharmacy technicians, and quality assurance professionals. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to meet the strictest environmental controls for compounding. We utilize advanced technology and validated processes to compound a wide range of preparations, including injectables, infusions, ophthalmics, and other sterile products. Our commitment to compliance and quality is unwavering, as we are subject to regular FDA inspections and stringent regulatory oversight. By operating as a 503B outsourcing facility, we provide an additional layer of assurance to healthcare providers regarding the integrity and reliability of the medications they administer to their patients.
Our services are tailored to meet the specific needs of the medical community. We work closely with healthcare providers to ensure they have the necessary compounded medications to support patient care. The operational model of 503B Compounding Pharmacy allows for the anticipatory production of medications, which can be essential during drug shortages or for medications that are not commercially viable for large pharmaceutical companies to produce. Our location at 2160 W State Road 434, Longwood, FL 32779 is the center of our manufacturing and distribution activities. For more information about our compliance and services, please visit our website at https://503bcompoundingpharmacy.com/ or contact us directly at (407)993-1381.
Frequently Asked Questions
What does it mean to be a 503B outsourcing facility?
Being a 503B outsourcing facility means we are registered with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration requires us to comply with current good manufacturing practices (cGMP) and subjects us to federal oversight, unlike traditional compounding pharmacies that are primarily regulated by state boards of pharmacy.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in producing sterile compounded medications, which can include injectables, intravenous (IV) bags, ophthalmics, and other preparations that must be sterile. These are typically produced in larger batches for healthcare settings rather than for individual patient prescriptions.
Who can order from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779?
Our services are designed for healthcare entities. Orders are typically placed by hospitals, clinics, surgery centers, and other healthcare providers. We do not generally dispense medications directly to individual patients.
How does 503B Compounding Pharmacy ensure medication quality?
We ensure quality through strict adherence to cGMP standards. This involves rigorous testing of components, validated sterile compounding processes, environmental monitoring, and comprehensive quality control checks throughout the production cycle at our facility.
What is the advantage of using a 503B outsourcing facility?
The primary advantage is the assurance of quality and compliance with federal manufacturing standards. For healthcare providers, this means access to high-quality, reliable compounded medications, especially important for drugs in shortage or those not available from conventional manufacturers.