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 a commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of traditional compounding. As a 503B outsourcing facility, our processes are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring that every preparation meets precise specifications.
The primary function of 503B Compounding Pharmacy is to provide bulk compounded medications for healthcare facilities. We serve hospitals, clinics, and other healthcare providers by producing significant quantities of medications that may be in short supply or are not available from conventional pharmaceutical manufacturers. By operating under Section 503B, we help mitigate drug shortages and provide essential medications that are critical for patient care. The medications compounded at our Longwood location are prepared without patient-specific prescriptions and are intended for office use by healthcare practitioners.
Quality control is the cornerstone of our operations at 2160 W State Road 434. Our state-of-the-art facility employs advanced environmental monitoring, stringent testing protocols, and validated processes to ensure sterility and potency. Every batch of medication undergoes rigorous analytical testing to verify its identity, strength, quality, and purity. This level of quality assurance is a fundamental requirement of being an FDA-registered 503B outsourcing facility and provides healthcare professionals with the confidence that the medications they administer are safe and effective.
503B Compounding Pharmacy focuses on compounding medications that are often on the FDA’s drug shortage list or are needed in specific formulations not commercially available. This includes sterile injectables, ophthalmics, and other dosage forms required in a clinical setting. Our ability to compound on a larger scale allows us to respond promptly to the evolving needs of the healthcare community in Longwood. Healthcare providers can rely on our 503B outsourcing facility as a trusted source for high-quality compounded preparations.
The team at 503B Compounding Pharmacy comprises highly skilled pharmacists, pharmacy technicians, and quality assurance professionals. Their expertise is focused on the complex science of large-scale compounding within the regulatory framework of Section 503B. Continuous training and adherence to cGMP standards ensure that our staff is proficient in the latest compounding techniques and compliance requirements. This dedication to excellence ensures that every product leaving our facility at 2160 W State Road 434 meets the highest professional standards.
For more information about 503B Compounding Pharmacy and our services, please contact us. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
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 Section 503B of the FD&C Act. This registration subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring a higher level of quality and safety for our compounded medications compared to traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for healthcare facilities and practitioners. Our products are intended for office use by physicians, hospitals, and clinics. We do not compound medications based on individual patient prescriptions for the general public; our services are specifically for healthcare providers.
What types of medications does 503B Compounding Pharmacy produce?
We specialize in large-scale compounding of medications that are often in short supply or unavailable from standard manufacturers. This includes sterile injectables, ophthalmics, and other formulations required by healthcare providers for their patients at their practice locations.
How does 503B Compounding Pharmacy ensure the quality of its preparations?
Quality is ensured through strict adherence to cGMP regulations. This involves rigorous environmental monitoring, validated sterilization processes, and comprehensive testing of every batch for sterility, potency, and purity. Our quality control laboratory at our Longwood facility performs these essential checks.
Can I pick up a medication directly from your location at 2160 W State Road 434?
No, 503B Compounding Pharmacy does not dispense medications directly to individual patients. All orders are distributed to the healthcare facilities and practitioners we serve. Patients should contact their healthcare provider for information about medications administered in a clinical setting.