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 status means we adhere to rigorous current good manufacturing practices (cGMP) and are subject to regular FDA inspections, ensuring a level of quality control and consistency that is paramount for patient safety and therapeutic efficacy.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. Our services are designed to support healthcare providers and facilities by providing them with essential medications that are not commercially available or are in shortage. By operating from our location at 2160 W State Road 434, Longwood, FL 32779, we are a reliable local source for physicians, surgeons, dermatologists, veterinarians, and other medical professionals who require access to high-quality, ready-to-administer medications for their patients. Our offerings include a range of sterile injectables, ophthalmics, and other preparations necessary for various clinical settings.
Our operational model at 503B Compounding Pharmacy is built on a foundation of precision and reliability. Every batch of medication produced within our facility undergoes stringent testing and quality assurance protocols. This process includes analytical testing to verify potency, sterility testing to ensure the absence of microbial contaminants, and endotoxin testing to guarantee patient safety. The medications prepared at our Longwood location are distributed directly to healthcare practitioners, enabling them to stock their offices with critical drugs needed for procedures and treatments, thereby enhancing patient care and operational efficiency for local medical practices.
Engagement with the local medical community is a priority for 503B Compounding Pharmacy. We establish direct relationships with healthcare providers serving patients from our facility at 2160 W State Road 434. Our team is dedicated to understanding the specific needs of these practices, offering a dependable supply chain for medications that may be experiencing national backorders or are not produced by large pharmaceutical manufacturers. This local presence ensures timely delivery and facilitates clear communication, allowing us to be a responsive and trusted partner in patient care for the medical professionals in our immediate area.
For healthcare providers seeking a compliant and quality-focused source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a dedicated resource. We invite local medical practices to learn more about our services and how we can support their clinical operations. You can reach us by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 stringent current good manufacturing practices (cGMP) and undergo regular FDA inspections, ensuring the highest standards of quality, sterility, and safety for the medications we compound.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility are provided for office use by healthcare practitioners. We serve physicians, hospitals, clinics, and other healthcare entities that require bulk compounded sterile preparations for their patients. We do not dispense medications directly to individual patients at our Longwood location.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in compounding sterile preparations, including injectables, ophthalmics, and other formulations that are often on shortage or are not commercially available. These are produced in batches for healthcare providers to have on hand for procedures and treatments at their practices.
How does 503B Compounding Pharmacy ensure medication quality?
Quality is assured through a rigorous process that includes analytical testing for potency, sterility testing, and endotoxin testing. Every batch produced at our Longwood facility is subject to these strict quality control measures before being released to a healthcare provider.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach our facility by calling (407)993-1381. More information about our services and processes is also available on our website at https://503bcompoundingpharmacy.com/.