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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are located at 2160 W State Road 434, Longwood, FL 32779, providing essential pharmaceutical compounding services from this specific facility. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing compounded medications in large batches for healthcare providers without patient-specific prescriptions. Our operations are distinct from traditional 503A compounding pharmacies, focusing on supplying sterile and non-sterile medications to hospitals, clinics, and healthcare practitioners for office use.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is committed to rigorous quality control. Our facility undergoes regular FDA inspections to ensure compliance with Current Good Manufacturing Practices (cGMP). This commitment guarantees that every medication we produce meets stringent standards for potency, purity, and sterility. Healthcare professionals who source medications from our Longwood location can be confident in the integrity and reliability of our products, which are essential for patient treatment and office-based procedures.
Our core service at the 2160 W State Road 434 facility is the large-scale compounding of medications. This includes the production of sterile injectables, ophthalmics, and other formulations that are in high demand within clinical settings. By operating as a 503B outsourcing facility, we provide a critical supply chain component for the local healthcare community, ensuring access to necessary drugs that may be in short supply or unavailable from conventional manufacturers. Our work supports the efficient and safe delivery of care from our specific location in Longwood, FL 32779.
Healthcare providers can engage with 503B Compounding Pharmacy by contacting us directly. We provide our compounded medications to practitioners for office use, ensuring they have the necessary supplies on hand to treat patients effectively. Our team is dedicated to supporting the medical community at our address on W State Road 434 with consistent, high-quality pharmaceutical products. For more information or to discuss your facility's needs, please contact 503B Compounding Pharmacy at our phone number: (407)993-1381, or visit our website at .
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. We compound medications in larger batches for office use by healthcare practitioners, adhering to strict federal manufacturing standards instead of state pharmacy regulations.
2. Who can receive medications from your Longwood facility?
503B Compounding Pharmacy provides compounded medications to healthcare entities and practitioners for office use. This includes hospitals, clinics, and other healthcare providers who can then administer these medications to patients within their practice at 2160 W State Road 434, Longwood, FL 32779.
3. How does the quality control at your facility work?
As an FDA-registered 503B outsourcing facility, we operate under Current Good Manufacturing Practices (cGMP). This involves rigorous testing of ingredients, environmental monitoring, and validation of processes to ensure every product leaving our location at 2160 W State Road 434 meets defined standards for safety, sterility, and strength.
4. Can I as an individual patient get a prescription filled at your location?
No. 503B Compounding Pharmacy does not compound patient-specific prescriptions. We supply medications in bulk for office use to healthcare providers. Individual patients should contact a traditional 503A compounding pharmacy for personalized prescriptions.
5. How can a healthcare provider at your location order medications?
Healthcare providers and facilities can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on available medications, ordering procedures, and delivery options from our facility at 2160 W State Road 434, Longwood, FL 32779.