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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility at its location on 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding, an outsourcing facility produces medications without patient-specific prescriptions in advance of receiving orders, adhering to rigorous current good manufacturing practices (cGMP). This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to a consistent and reliable supply of high-quality compounded sterile preparations.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile injectable medications. This includes a significant focus on providing office-use medications for physicians, clinics, and other healthcare entities operating at 2160 W State Road 434, Longwood, FL 32779. These medications are essential for a wide range of treatments, including hormone replacement therapy, pain management, ophthalmic procedures, and nutritional supplementation. By sourcing from an FDA-registered 503B outsourcing facility, healthcare professionals can be assured of the integrity, potency, and sterility of the medications they administer to their patients, which is paramount for patient safety and positive health outcomes.
Operating from 2160 W State Road 434, Longwood, FL 32779, the pharmacy’s processes are defined by strict adherence to cGMP. This encompasses every aspect of production, from the sourcing and testing of active pharmaceutical ingredients and excipients to the meticulous environmental controls within the cleanroom suites. Personnel undergo extensive training in aseptic techniques and garbing procedures to prevent contamination. Finished products are subjected to thorough testing, including sterility testing and endotoxin testing, to verify their safety before they are released for distribution. This comprehensive quality assurance framework is a fundamental aspect of the 503B outsourcing facility model.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with 503B Compounding Pharmacy offers distinct advantages. It mitigates the risks associated with using medications from less regulated compounding sources and reduces the administrative burden on clinical staff who would otherwise need to compound these medications in-house. The availability of ready-to-use, batch-tested medications from a trusted 503B outsourcing facility enhances operational efficiency and allows medical professionals to dedicate more time to direct patient care. The pharmacy serves as a critical partner in the local healthcare ecosystem, supporting the delivery of advanced and safe medical treatments.
To learn more about the services available from this 503B outsourcing facility or to discuss your specific needs, you can contact 503B Compounding Pharmacy directly. The team is available to provide information and support to the medical community at 2160 W State Road 434, Longwood, FL 32779. Reach out via phone at (407)993-1381 or visit the website at .
FAQ
1. What does it mean that this facility is a 503B outsourcing facility?
It means our location at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B of the FD&C Act. We produce compounded sterile medications in large batches for office use by healthcare providers, following strict current good manufacturing practices (cGMP) for quality and safety.
2. Can individual patients get prescriptions filled directly at 2160 W State Road 434, Longwood, FL 32779?
No. As a 503B outsourcing facility, our primary function is to supply medications for "office use" to licensed practitioners and healthcare entities. Patients should receive their treatments directly from their healthcare provider who sources medications from our facility.
3. What types of medications does this 503B compounding pharmacy produce?
We specialize in sterile injectable medications, which can include formulations for hormone therapy, pain management, vitamins, and electrolytes. These are produced for healthcare providers to administer to patients within their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How does using a 503B outsourcing facility benefit our local clinic?
Sourcing from our facility at 2160 W State Road 434, Longwood, FL 32779 provides your clinic with medications that meet the highest federal quality standards. This ensures patient safety, reduces your clinic's compounding burden, and provides a reliable supply of essential injectables.
5. How can a healthcare provider at this location place an order?
Healthcare providers and entities at 2160 W State Road 434, Longwood, FL 32779 can initiate an order or inquire about our available formulations by contacting us directly at (407)993-1381. Our team will guide you through the process.