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 providing high-quality compounded medications. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP). This ensures that every preparation meets stringent standards for strength, quality, and purity. Our primary focus is on producing large-scale batches of compounded sterile preparations (CSPs) for office use by healthcare practitioners. We serve as a critical partner for medical professionals in need of reliable, ready-to-administer medications for their patients.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. Our status as a 503B outsourcing facility means we are subject to federal oversight and must comply with detailed FDA regulations. This includes comprehensive testing of components, containers, and excipients, as well as stability testing and beyond-use date assignment based on scientific data. The environment at our Longwood location is meticulously controlled, with advanced air filtration systems and strict aseptic techniques employed to prevent contamination. Healthcare providers can confidently utilize our products, knowing they are sourced from a facility that prioritizes patient safety above all else.
Our services at 2160 W State Road 434 are designed to support the local medical community. We provide healthcare practitioners with access to a consistent supply of essential medications that may be in short supply or not commercially available. By working directly with 503B Compounding Pharmacy, medical offices can streamline their inventory management, reduce waste, and ensure they have the necessary preparations on hand for immediate patient care. Our team of qualified professionals, including pharmacists and technicians, is committed to excellence in every aspect of the compounding process.
For more information about our services and regulatory compliance, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What is a 503B outsourcing facility?
A 503B outsourcing facility is an entity registered with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities compound human drugs and must comply with current good manufacturing practice (cGMP) requirements. They are permitted to compound large volumes of medications without patient-specific prescriptions for office use by healthcare practitioners.
Who can order from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare practitioners. This includes physicians, surgeons, and other qualified medical professionals who require compounded sterile preparations for use in their practice settings.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile preparations (CSPs). These are typically injectable medications that are produced under strict aseptic conditions. Our focus is on medications that are essential for office-based procedures or that may be on the drug shortage list.
How does the quality assurance process work at your facility?
Quality assurance is paramount. Our processes at 2160 W State Road 434, Longwood, FL 32779 include rigorous testing of ingredients, environmental monitoring of our cleanrooms, and validation of our sterilization methods. Every batch is produced following strict cGMP standards to ensure safety, potency, and sterility.
How can I learn more about your available products?
Healthcare practitioners interested in our services can learn more by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381. We are located at 2160 W State Road 434, Longwood, FL 32779 and can provide detailed information tailored to your practice's needs.