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 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 pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, which are the same standards applied to major pharmaceutical manufacturers. This ensures that every medication produced at the Longwood facility meets stringent requirements for sterility, potency, and purity, providing healthcare providers and patients with a trusted source for essential drugs.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but not individually identified. This means the facility prepares batches of medications in advance of receiving a prescription, based on historical demand from healthcare providers. The medications produced are typically sterile injectables, which are often in short supply from conventional manufacturers. By operating from its location at 2160 W State Road 434, this 503B facility serves a critical role in the local healthcare infrastructure, helping to alleviate drug shortages and ensure a consistent supply of vital medications for patients in Longwood who require them.
Healthcare professionals, including those at hospitals, clinics, and surgical centers in the area, rely on the services of 503B Compounding Pharmacy for a dependable supply of high-quality compounded medications. The facility's operations are designed to support the local medical community by providing medications that are essential for a wide range of treatments, including hormonal therapies, ophthalmologic preparations, and pain management solutions. The team at the Longwood location comprises highly trained pharmacists, chemists, and quality control professionals who utilize state-of-the-art technology and cleanroom environments to compound medications with precision and care.
For patients and prescribers at 2160 W State Road 434, Longwood, FL 32779, engaging with a 503B Compounding Pharmacy offers a distinct level of assurance. The federal oversight and cGMP compliance provide a layer of safety and quality control that goes beyond traditional pharmacy practice. Patients can have confidence that the medications they receive, though compounded, are produced under the most rigorous conditions. To learn more about the specific medications available or to inquire about services, you can contact 503B Compounding Pharmacy via their website at or by phone at (407)993-1381.
FAQ
1. What does it mean that this is a 503B compounding pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds medications in large batches for healthcare providers. It operates under strict federal regulations and current Good Manufacturing Practices (cGMP) to ensure the highest standards of quality, sterility, and safety for all medications produced at 2160 W State Road 434, Longwood, FL 32779.
2. Who can receive medications from this 503B compounding pharmacy?
Medications are dispensed pursuant to a prescription from a licensed healthcare provider. The facility primarily provides compounded medications to healthcare professionals and entities for office use and for administration to their patients within their practice at 2160 W State Road 434.
3. What types of medications does this 503B facility compound?
As a 503B outsourcing facility, the primary focus is on compounding sterile injectable medications, which are often drugs that are on shortage from conventional manufacturers. This includes preparations for pain management, hormone replacement therapy, and other essential injectable treatments needed by local healthcare providers.
4. How does the quality control at a 503B facility differ from a regular pharmacy?
This 503B compounding pharmacy adheres to cGMP standards mandated by the FDA. This involves rigorous environmental monitoring, extensive testing of raw materials and finished products for sterility and potency, and validated processes that far exceed the standards required of a traditional compounding pharmacy, ensuring exceptional quality for every batch.
5. How can a healthcare provider at this location place an order?
Healthcare providers can place orders directly with the facility by calling (407)993-1381. The team will provide information on available medications, assist with the ordering process, and ensure compliance with all necessary regulations for dispensing.