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 at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality, safety, and production, which are distinct from traditional compounding pharmacies. Our primary mission is to provide healthcare providers in Longwood with access to high-quality, compounded medications that are essential for patient care but may be commercially unavailable or in short supply.
The operations at our location on W State Road 434 are focused on producing medications for office use. This means we supply physician offices, hospitals, and other healthcare facilities with the necessary medications to administer to patients directly within their practice. We compound a significant volume of injectable medications, including IV bags, syringes, and other sterile preparations that are critical for various treatments and procedures. By ensuring a reliable supply of these essential drugs, we support the local medical community in delivering efficient and effective care to their patients.
Our status as a 503B outsourcing facility mandates compliance with Current Good Manufacturing Practices (cGMP). This commitment to excellence is evident in every step of our process at the Longwood facility. Our cleanrooms are designed to meet stringent environmental controls to prevent contamination. Every batch of medication we produce undergoes rigorous testing and quality control checks to ensure potency, purity, and sterility. This level of quality assurance provides healthcare professionals at 2160 W State Road 434 with the confidence that the medications they use meet the highest possible standards.
While we do not provide compounded medications directly to individual patients from our location, we are a vital component of the local healthcare infrastructure. Physicians and healthcare providers in Longwood rely on our services to obtain medications for office use, ensuring they have the right tools to treat their patients effectively. For more information about our services or to inquire about becoming a client, please contact us directly. We are committed to supporting the health and well-being of the community through our specialized compounding services.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. 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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires us to comply with stricter federal standards, including Current Good Manufacturing Practices (cGMP), for the production of compounded medications intended for office use by healthcare providers.
2. Can I, as an individual patient, pick up a prescription at your location?
No. 503B Compounding Pharmacy provides medications for office use to healthcare facilities and practitioners. We do not compound patient-specific prescriptions or dispense medications directly to the public from our facility at 2160 W State Road 434. Your healthcare provider will administer any medications we compound directly to you in their office.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility primarily compounds large-scale batches of sterile injectable medications, such as IV bags, syringes, and other preparations that are often used in clinics, hospitals, and surgical centers. These are medications that are on the FDA drug shortage list or are not otherwise commercially available for healthcare providers to purchase.
4. How does a healthcare provider at 2160 W State Road 434 order from you?
Healthcare providers and facilities can establish an account with our pharmacy. Orders are typically placed directly through our dedicated channels. For detailed information on becoming a client and our ordering process, please contact our facility at (407)993-1381.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours ensures that the medications received are produced under the highest standards of quality and safety mandated by federal law. This provides assurance regarding the sterility, potency, and purity of the medications used in patient care, which is crucial for patient safety and effective treatment outcomes.