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 is a critical component of our operational identity, distinguishing our services and reinforcing our commitment to the highest standards of pharmaceutical compounding. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP) to ensure the quality, safety, and efficacy of our preparations for the healthcare providers 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) that are distributed to healthcare facilities without patient-specific prescriptions. This model is essential for hospitals, clinics, and surgical centers operating at 2160 W State Road 434, Longwood, FL 32779, providing them with access to essential medications that may be in shortage or not commercially available. Our operations are designed to support the local medical community by delivering bulk quantities of high-quality, sterile medications, thereby enhancing patient safety and streamlining clinical workflows.
Our presence at 2160 W State Road 434, Longwood, FL 32779 is central to our mission. Every preparation is compounded within our state-of-the-art cleanroom environment at this facility, under the supervision of expert pharmacists and trained technicians. We utilize advanced technology and stringent testing protocols to guarantee the sterility, stability, and potency of every product that leaves our facility. This localized focus ensures that healthcare providers at our address receive consistent, reliable, and timely access to the critical medications their patients depend on.
503B Compounding Pharmacy is dedicated to serving the specific needs of the medical community at 2160 W State Road 434, Longwood, FL 32779. We provide a vital link in the healthcare supply chain, mitigating drug shortages and offering compounded preparations that meet unique clinical requirements. For more detailed information about our 503B compounding services or to initiate an order, we invite you to contact us directly. You can reach our facility by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
What does it mean that you are a 503B outsourcing facility at 2160 W State Road 434? It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. This registration requires us to comply with stringent federal standards, including current good manufacturing practices (cGMP), for the large-scale compounding of sterile medications that are distributed to healthcare facilities.
Who can receive medications from your 503B Compounding Pharmacy? Our 503B Compounding Pharmacy distributes compounded medications to healthcare facilities and practitioners, such as hospitals, clinics, and surgical centers. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779 without a valid patient-specific prescription, which is handled under different regulations.
What types of preparations does your Longwood facility compound? Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations (CSPs). This includes a wide range of injectable medications, IV bags, ophthalmics, and other sterile products that are essential for medical procedures and patient care within healthcare settings.
How does your 503B pharmacy help with drug shortages? 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can compound preparations for medications that are listed on the FDA drug shortage list. This provides a critical alternative source for healthcare providers when commercially manufactured drugs are unavailable, helping to ensure continuity of care.
How can a healthcare facility at your address place an order? Healthcare facilities can contact 503B Compounding Pharmacy directly to discuss their needs and place orders. Our team at 2160 W State Road 434, Longwood, FL 32779 can be reached by phone at (407)993-1381. More information about our processes and capabilities is also available on our website at https://503bcompoundingpharmacy.com/.