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 located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality control benchmarks for the medical professionals and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. Our services are specifically designed for healthcare providers with practices near 2160 W State Road 434, Longwood, FL 32779. We provide physicians and clinics with essential medications that are often in short supply or discontinued by major manufacturers. By preparing these medications in advance and under sterile conditions, we enable local healthcare providers to have critical drugs readily available for their patients, supporting efficient and effective treatment plans without the delays associated with traditional pharmacy dispensing.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology, including ISO Class 7 cleanrooms and isolator technology, to guarantee the sterility and potency of our preparations. Every batch is meticulously tested and documented to provide an unparalleled level of safety and reliability. The team at 503B Compounding Pharmacy comprises highly skilled pharmacists and technicians who are experts in sterile compounding processes. We are dedicated to supporting the local medical community by providing a dependable source for high-quality, compounded medications that are essential for patient care in the Longwood area.
For healthcare providers seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a resource of integrity and excellence. We invite you to learn more about our processes and how we can support your practice. Contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381 to speak with a representative.
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 and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and adhere to strict current Good Manufacturing Practice (cGMP) regulations, which are the same standards required of large pharmaceutical manufacturers. This ensures a higher level of quality control and consistency for the compounded medications we produce.
Who can receive medications from 503B Compounding Pharmacy?
As an outsourcing facility, our primary clients are healthcare providers, such as physicians, clinics, and hospitals. We supply medications for "office use," meaning a healthcare professional can administer them to patients within their practice located near 2160 W State Road 434, Longwood, FL 32779. We do not typically dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy prepare?
We specialize in the large-scale compounding of sterile preparations, including injectables, ophthalmics, and other formulations that require an aseptic environment. Common preparations include hormone injections, pain management solutions, and medications that are currently on drug shortage lists from commercial manufacturers, all produced at our facility on W State Road 434.
How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434 is comprehensive. It includes rigorous testing of components, in-process testing, and finished preparation testing. We perform sterility testing, endotoxin testing, and potency assays to verify that every batch of medication meets its specified identity, strength, quality, and purity characteristics before it is released.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order or inquire about our services by contacting 503B Compounding Pharmacy directly. The preferred method is to call our dedicated phone line at (407)993-1381 to speak with our team. You can also find more information and contact forms on our official website at https://503bcompoundingpharmacy.com/.