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 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 unwavering commitment to the highest standards of quality, safety, and regulatory oversight, far exceeding those of traditional compounding pharmacies. We serve a critical role in the healthcare ecosystem by providing bulk compounded medications for physician offices, hospitals, and healthcare providers, ensuring they have access to essential drugs that are often unavailable or in short supply from conventional manufacturers.
The core mission of 503B Compounding Pharmacy is to alleviate drug shortages and provide customized medication solutions that meet specific patient needs. By operating under the rigorous cGMP (current Good Manufacturing Practices) standards mandated for 503B outsourcing facilities, we guarantee a level of sterility assurance, potency, and purity that is vital for patient safety. Every process within our Longwood facility, from ingredient sourcing to final packaging, is meticulously controlled and documented. Our highly skilled team of pharmacists and technicians utilizes state-of-the-art technology and cleanroom environments to produce medications that healthcare professionals can trust implicitly for their patients.
For healthcare providers seeking a reliable partner for compounded pharmaceutical needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and reliability. We encourage you to connect with us to discuss how our services can support your practice and enhance patient care. You can reach our facility directly at (407)993-1381 or learn more about our capabilities and compliance standards by visiting our official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific 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, including cGMP, for the large-scale compounding of medications. This ensures a higher level of quality control and regulatory oversight compared to a traditional pharmacy.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily supplies compounded medications in bulk to healthcare providers and institutions, such as physician offices, clinics, and hospitals, for office-use. We do not typically dispense medications directly to individual patients at our Longwood location.
What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility in Longwood specializes in compounding a wide range of sterile and non-sterile medications, often focusing on formulations that are on drug shortage lists or are not commercially available from standard pharmaceutical manufacturers.
How does 503B Compounding Pharmacy ensure medication safety and quality?
Our facility on W State Road 434 adheres to rigorous cGMP standards. This involves stringent testing of ingredients, validated sterility processes, environmental monitoring of our cleanrooms, and comprehensive quality control checks on every batch of medication we compound.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers and institutions can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their specific medication needs and initiate the ordering process. Our team is available to provide information and support.