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. Unlike traditional compounding pharmacies, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring that every batch of medication we produce meets stringent federal requirements for strength, quality, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare facilities. We provide healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable, trusted source for essential medications that are often in short supply or unavailable from conventional manufacturers. Our services are designed to support the operational needs of medical practices by providing ready-to-use, office-stock medications, thereby enhancing patient care and streamlining clinical workflows. By outsourcing their compounding needs to our 503B facility, healthcare providers can be assured of receiving consistent, high-quality products.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced environmental controls, including ISO-classified cleanrooms, to ensure the sterility and integrity of all our preparations. Our highly trained team of pharmacists and technicians follows exacting protocols for every step of the compounding process, from ingredient sourcing and testing to final product release. This meticulous attention to detail and unwavering commitment to cGMP standards defines the 503B Compounding Pharmacy service and provides peace of mind to the healthcare community we serve at our Longwood location.
For healthcare providers seeking a dependable partner for their compounded medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and reliability. We invite you to contact us to learn more about our services and how we can support your practice. You can reach us by phone at (407)993-1381 or visit our website for more information at https://503bcompoundingpharmacy.com/.
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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires us to comply with Current Good Manufacturing Practices (cGMP), which are stringent federal regulations for drug manufacturing that ensure identity, strength, quality, and purity.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers and facilities for office use. We do not provide medications directly to individual patients. Our services are designed to supply practitioners at 2160 W State Road 434, Longwood, FL 32779 with office-stock compounded preparations.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in the large-scale compounding of sterile injectable medications. This includes preparations like hormone injections, vitamin complexes, and other sterile solutions that are commonly used in clinical settings at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It includes rigorous testing of incoming ingredients, environmental monitoring of our cleanrooms, and validated sterility testing on finished products. Every batch is released only after meeting all specified quality control parameters as required by cGMP.
How can a healthcare provider at this location place an order?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can initiate orders by contacting 503B Compounding Pharmacy directly. Please call our facility at (407)993-1381 to speak with a representative or visit https://503bcompoundingpharmacy.com/ for more information on our ordering process.