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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our adherence to the most rigorous federal standards for quality, safety, and production. Unlike traditional compounding, our 503B status means our medications are produced in bulk for healthcare facilities without patient-specific prescriptions, ensuring a reliable and consistent supply for the medical community at our specific location.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality compounded medications that may be commercially unavailable or in short supply. Our operations at 2160 W State Road 434, Longwood, FL 32779 are strictly regulated, involving stringent environmental controls, validated processes, and robust quality assurance testing. This ensures every preparation leaving our facility meets precise sterility, potency, and purity specifications. We serve as a critical partner to hospitals, clinics, and other healthcare entities by providing them with essential medications they can trust.
Our services are defined by our compliance with Current Good Manufacturing Practices (cGMP). The team at our Longwood facility is comprised of skilled pharmacists and technicians who specialize in compounding complex formulations. The environment at 2160 W State Road 434 is meticulously controlled, with air quality, equipment, and procedures all designed to prevent contamination. We provide a vital service by compounding preparations that are not available from standard commercial manufacturers, helping to meet specific patient needs and address critical drug shortages from our established location.
503B Compounding Pharmacy is committed to supporting the local healthcare infrastructure from our facility at 2160 W State Road 434, Longwood, FL 32779. We work directly with healthcare professionals to supply them with the necessary medications for their practice. Our role is to be a dependable source for bulk compounded pharmaceuticals, produced under the exacting standards required of an FDA-registered 503B outsourcing facility. For more information or to discuss your facility's needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
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 under Section 503B of the FD&C Act. We operate under Current Good Manufacturing Practices (cGMP), which involve rigorous testing, environmental monitoring, and quality control procedures to ensure the safety, sterility, and potency of all medications we compound.
2. Can I as an individual patient get a prescription filled at 2160 W State Road 434?
No. 503B Compounding Pharmacy does not compound medications based on individual patient prescriptions. We are an outsourcing facility that compounds medications in bulk for healthcare facilities. Individual patients should contact a traditional 503A compounding pharmacy for their personal prescription needs.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a range of sterile and non-sterile medications in bulk quantities. This often includes preparations that are on drug shortage lists or are not commercially available from large pharmaceutical manufacturers. We produce these medications for healthcare providers to administer to patients within their practice.
4. Who can place an order with your pharmacy at this location?
Orders are placed by healthcare facilities and licensed medical professionals. This includes hospitals, surgery centers, clinics, and physician practices. We do not accept orders directly from individual consumers or patients. All inquiries from healthcare providers can be directed to (407)993-1381.
5. How does the quality control process work at your Longwood facility?
Quality control is integral to our operation at 2160 W State Road 434. Every batch of medication undergoes extensive testing to verify its identity, strength, quality, and purity. Sterile preparations are compounded in ISO-classified cleanrooms, and our processes are continuously validated to meet cGMP standards, ensuring the highest level of safety and efficacy for the healthcare providers we serve.