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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, current good manufacturing practices (cGMP), and rigorous testing protocols to ensure the medications we provide are of exceptional purity, strength, and quality. Our mission is to support the healthcare providers and patients at our location with reliable, large-scale compounded pharmaceutical solutions.
The operations at 503B Compounding Pharmacy are fundamentally different from a traditional compounding pharmacy. Our 503B status means we are subject to FDA oversight and manufacture compounded drugs for office use without patient-specific prescriptions. This allows physicians, surgeons, hospitals, and clinics to have essential medications readily available for immediate patient care. The facility at 2160 W State Road 434 is equipped with state-of-the-art technology and staffed by a team of experienced pharmacists and technicians who are experts in the art and science of compounding within a regulated environment.
We specialize in the production of a wide array of compounded formulations, including sterile injectables, ophthalmics, and other dosage forms that are in high demand within clinical settings. The medications produced at our Longwood facility are critical for a variety of treatments and procedures, ensuring that healthcare professionals have access to the specific medications they need. Every batch is meticulously crafted and undergoes extensive testing to verify sterility and potency, providing an unparalleled level of safety and efficacy for the patients who ultimately receive them.
503B Compounding Pharmacy is committed to being a trusted partner to the medical community at our location. We understand the critical nature of the medications we produce and the importance of timely access and absolute reliability. Our team works diligently to maintain efficient production schedules and robust quality assurance systems. For more information about our services or to discuss your needs, please contact us directly. You can reach our facility at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.
FAQ
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 operates under Section 503B of the FD&C Act. This subjects us to federal oversight, mandatory compliance with current good manufacturing practices (cGMP), and routine FDA inspections to ensure the highest quality and safety standards for our compounded medications.
2. Who can order medications from 503B Compounding Pharmacy at this location?
Our medications are produced for office use and are distributed to healthcare professionals and entities. This includes physicians, surgeons, hospitals, ambulatory surgery centers, and clinics that require bulk compounded pharmaceuticals for their practice and patients at our location.
3. Do you compound medications for individual patients with a prescription?
No. 503B Compounding Pharmacy operates as an outsourcing facility that compounds medications in large batches for office use by healthcare providers. We do not compound patient-specific prescriptions, which is the role of a traditional 503A pharmacy.
4. How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434 is comprehensive. It includes stringent environmental monitoring, validation of all processes and equipment, and rigorous testing of finished drug products for sterility, potency, and endotoxins by an independent laboratory to ensure every batch meets exacting specifications.
5. How can a healthcare provider at this location place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We encourage you to call us at (407)993-1381 to speak with a representative or visit https://503bcompoundingpharmacy.com/ for more information on becoming an account holder and placing orders.