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 precisely 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 adheres to rigorous current good manufacturing practices (cGMP), ensuring that every preparation meets stringent federal guidelines for sterility, potency, and purity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare facilities. Our operations at 2160 W State Road 434, Longwood, FL 32779 are dedicated to providing healthcare providers with access to critical medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers. By producing these essential medications in bulk, we provide a reliable and trusted source for physicians, hospitals, and clinics, helping to mitigate drug shortages and support patient care protocols.
Our services at the 2160 W State Road 434, Longwood, FL 32779 location are defined by our regulatory status. As a 503B outsourcing facility, our processes are subject to regular and unannounced FDA inspections, providing an additional layer of oversight and assurance for the healthcare providers we serve. We utilize state-of-the-art technology and environmental controls within our facility to ensure the integrity of every preparation. The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists and technicians who are experts in sterile compounding techniques, working diligently to uphold the impeccable standards required by our designation.
For healthcare entities seeking a dependable partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a pinnacle of quality and reliability. We invite you to learn more about our specific services and capabilities by visiting our website or contacting our facility directly. You can reach us at (407)993-1381 or explore the information available online at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 requires us to comply with current good manufacturing practices (cGMP) and subjects us to regular FDA inspections, ensuring the highest level of quality and safety for our compounded preparations.
2. Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
As a 503B outsourcing facility, we provide compounded medications primarily to healthcare practitioners and facilities for office use and administration to patients. We do not typically dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779 without a specific arrangement through a prescribing practitioner.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in the large-scale compounding of sterile injectable medications. This often includes preparations that are on drug shortage lists, such as specific hormones, electrolytes, and other critical care medications needed by healthcare providers.
4. How does the quality control process work at your facility?
Our quality control at 2160 W State Road 434, Longwood, FL 32779 is comprehensive and mandated by cGMP standards. It includes rigorous testing for sterility, endotoxins, potency, and stability. Every batch is meticulously documented and reviewed by our quality unit before being released, ensuring it meets all specified criteria.
5. How can a healthcare facility place an order with your pharmacy?
Healthcare facilities and practitioners can initiate an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 will provide information on our available preparations, ordering process, and requirements.