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 is an FDA-registered outsourcing facility operating under Section 503B of the Drug Quality and Security Act. We are a specialized pharmacy located at 2160 W State Road 434, Longwood, FL 32779, dedicated to the large-scale compounding of sterile and non-sterile medications. Unlike traditional pharmacies, our 503B status signifies our adherence to the most rigorous federal standards for quality, safety, and consistency. This ensures that every preparation leaving our facility meets stringent testing and production protocols, providing healthcare providers and patients with the highest level of confidence.
Our core mission at our Longwood facility is to support the medical community by providing bulk quantities of compounded medications that are often in short supply or unavailable from conventional manufacturers. We serve hospitals, clinics, and healthcare practitioners by producing essential medications, including sterile injectables, ophthalmics, and other critical care formulations. By operating as a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we help alleviate drug shortages and provide a reliable source for high-quality, patient-specific preparations that are vital for effective treatment plans.
The operations at 503B Compounding Pharmacy are defined by an unwavering commitment to pharmaceutical science and regulatory excellence. Our state-of-the-art facility on W State Road 434 is designed with advanced environmental controls and utilizes cutting-edge technology to ensure the integrity of every compound. Our team of highly skilled pharmacists and technicians follows exacting procedures under a quality management system that far exceeds typical pharmacy standards. This meticulous approach guarantees that every product is compounded accurately, free from contaminants, and of the highest possible purity.
For healthcare providers seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a pinnacle of reliability and quality. We understand the critical nature of the medications we produce and the profound impact they have on patient outcomes. Our dedicated local team is committed to upholding the principles of 503B compounding through continuous improvement, transparency, and a patient-first philosophy. To learn more about our services or to discuss your specific needs, we encourage you to contact us directly.
You can reach 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to provide you with detailed information and support.
FAQ
1. 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 operates in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration subjects us to heightened federal oversight, including compliance with Current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies.
2. Who can receive medications from your Longwood location?
503B Compounding Pharmacy primarily provides compounded medications in bulk to healthcare facilities and practitioners, such as hospitals, clinics, and physician offices. These entities then administer the medications to their patients. We do not typically dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications do you compound at your facility?
Our 503B compounding pharmacy specializes in the large-scale production of sterile injectables and other formulations that are often on drug shortage lists. This includes IV bags, ophthalmics, and other critical care solutions. All our compounding activities are conducted on-site at 2160 W State Road 434, Longwood, FL 32779 under strict sterile conditions.
4. How does the quality control process work at your pharmacy?
Quality control is integral to our 503B operations. Every batch of medication compounded at our Longwood facility undergoes rigorous testing for sterility, potency, and endotoxins before it is released. Our processes are designed to meet or exceed all FDA requirements for an outsourcing facility, ensuring the highest level of safety and efficacy for the medications we produce.
5. How can a healthcare provider place an order with your pharmacy?
Healthcare providers and facilities can initiate orders by contacting our team directly at (407)993-1381. Our staff at 2160 W State Road 434, Longwood, FL 32779 will guide you through the process, discuss your specific requirements, and provide all necessary information regarding ordering, fulfillment, and delivery logistics.