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 2160 W State Road 434, Longwood, FL 32779. This designation, granted under Section 503B of the Federal Food, Drug, and Cosmetic Act, signifies adherence to the highest standards of pharmaceutical compounding. As a 503B outsourcing facility, this pharmacy prepares large batches of compounded sterile preparations (CSPs) for office use by healthcare practitioners, without patient-specific prescriptions. The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under rigorous FDA cGMP (current Good Manufacturing Practice) regulations, ensuring a level of quality, sterility, and safety that is paramount for patient care.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is to provide healthcare providers with access to essential medications that are often in short supply or unavailable from traditional manufacturers. By producing these medications in a controlled, sterile environment, the pharmacy helps to mitigate drug shortages and supports the continuity of care for patients in the local medical community. The team of highly trained pharmacists and technicians at this location utilizes state-of-the-art equipment and validated processes to compound a range of sterile injectables, including IV bags, epidurals, and ophthalmics, all within the specific regulatory framework of a 503B outsourcing facility.
Healthcare practitioners who source medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be confident in the integrity of the products they administer. The facility's commitment to compliance, quality control, and patient safety is embedded in every step of its operation. For more information or to inquire about services, please contact 503B Compounding Pharmacy at their website or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779?
It means this facility is registered with the FDA and compounds large volumes of sterile medications for office use by healthcare providers. It operates under strict federal cGMP standards, which are more rigorous than those applied to traditional compounding pharmacies, ensuring a higher level of quality control and sterility assurance for all products prepared at this location.
2. As a patient, can I get a prescription filled directly at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy primarily supplies medications to healthcare practitioners and clinics for office use. Patients receive these medications directly from their doctor during a procedure or office visit. You cannot present an individual prescription to this facility for fulfillment.
3. What types of medications are compounded at this specific location?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable preparations. This includes medications for anesthesia, pain management, antibiotics, and other solutions that are administered in clinical settings, such as hospitals, surgical centers, and doctors' offices.
4. How does a healthcare provider order from your facility?
Healthcare providers and medical facilities can establish an account and place orders by contacting 503B Compounding Pharmacy directly. You can initiate this process by calling (407)993-1381 to speak with a representative who can guide you through the onboarding and ordering procedures specific to this location.
5. Why should a clinic at 2160 W State Road 434, Longwood, FL 32779 use a 503B outsourcing facility?
Utilizing a 503B outsourcing facility like ours provides assurance of quality, compliance, and reliability. Clinics benefit from access to medications that may be on shortage, the convenience of office-use stock, and the confidence that comes with using products manufactured under the highest federally regulated standards for sterility and safety.