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 large quantities of sterile and non-sterile compounded preparations that are not available commercially.
As a 503B outsourcing facility, our operations are distinct from traditional compounding pharmacies. We are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility. Our primary mission is to provide healthcare practitioners with reliable access to high-quality compounded medications, thereby supporting enhanced patient care and treatment outcomes.
The services provided by 503B Compounding Pharmacy are integral to the local healthcare ecosystem. We work directly with physicians, hospitals, and clinics, enabling them to obtain necessary medications that are often in short supply or discontinued by large-scale manufacturers. By operating from our location at 2160 W State Road 434, Longwood, FL 32779, we ensure a consistent and dependable supply of critical medications, contributing to the stability and resilience of patient care in our community.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly skilled pharmacists and technicians. This team is dedicated to the precise and accurate compounding of a wide array of preparations. The environment is meticulously controlled to prevent contamination, with sterile compounding performed in ISO-classified cleanrooms. This unwavering dedication to excellence and safety is the foundation of our operation as a trusted 503B outsourcing facility.
For more information about our services or to discuss how we can support your practice, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/. Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to assist you.
Frequently Asked Questions
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 and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and adhere to current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This ensures a higher level of oversight and quality control for the compounded preparations we produce.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers and institutions. We do not dispense medications directly to individual patients. A licensed physician or healthcare facility must place an order for our compounded preparations, which are then administered to patients under their care.
What types of compounded preparations are available from your facility?
As a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we compound large batches of both sterile and non-sterile medications. This includes preparations like sterile injectables, ophthalmics, and other dosage forms that are often on drug shortage lists or are needed by hospitals and clinics in specific strengths or formulations not available from commercial manufacturers.
How does the quality control process work at your facility?
Our quality control process is extensive and mandated by cGMP regulations. It includes rigorous testing of raw materials, in-process testing during compounding, and finished preparation potency and sterility testing. Our cleanrooms at 2160 W State Road 434, Longwood, FL 32779 are continuously monitored to ensure they meet strict environmental standards for particulate matter and microorganisms.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers and institutions can initiate an order by contacting our facility directly. For ordering information and to speak with our team, please call (407)993-1381. You can also find more details about our capabilities and processes on our website at https://503bcompoundingpharmacy.com/.