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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. We specialize in the large-scale, non-patient-specific compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, sterility assurance, and testing, providing healthcare providers with a reliable source for compounded medications.
At our location on 2160 W State Road 434, Longwood, FL 32779, our primary focus is supplying compounded medications to healthcare facilities and practitioners. Our operations are distinct from traditional retail pharmacies, as we provide medications in bulk for office use. This enables local healthcare providers to have essential medications readily available for their patients without the need for individual prescriptions for each vial or tube. We compound a significant volume of medications, ensuring consistent supply and rigorous quality for the medical community we serve directly from our Longwood facility.
The 503B outsourcing facility model requires us to follow Current Good Manufacturing Practices (cGMP). This commitment to excellence is embedded in every process at our facility. From the sourcing of pure, high-quality active pharmaceutical ingredients (APIs) to the final testing of our finished products, every step is meticulously documented and controlled. This level of oversight provides an additional layer of safety and reliability for the healthcare providers who utilize our services at 2160 W State Road 434, Longwood, FL 32779.
Our services are integral to the local healthcare infrastructure. By providing sterile injectables, ophthalmics, and other crucial formulations, we support hospitals, clinics, and surgical centers in delivering effective patient care. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are dedicated to the science and safety of compounding. We are committed to maintaining our status as a trusted 503B outsourcing facility for practitioners who rely on our products at 2160 W State Road 434, Longwood, FL 32779.
For more information about our services, please visit our website at or contact us directly by phone at (407)993-1381. Our team is available to assist healthcare providers and answer questions regarding our compounding capabilities and processes.
FAQ
1. What does it mean that you are a 503B Compounding Pharmacy?
It means we are an FDA-registered outsourcing facility operating under Section 503B. We compound large quantities of medications for office use by healthcare providers, adhering to strict federal manufacturing standards, including Current Good Manufacturing Practices (cGMP).
2. Can I, as an individual patient, pick up a prescription at 2160 W State Road 434?
No. Our facility at 2160 W State Road 434, Longwood, FL 32779, supplies medications directly to healthcare providers and facilities for office use. Patients should obtain their compounded medications directly from their prescribing physician or clinic.
3. What types of medications do you compound at your Longwood location?
At our facility, we compound a wide range of sterile and non-sterile medications, including injectables, ophthalmics, and topical formulations. These are supplied in bulk to healthcare practices located at 2160 W State Road 434, Longwood, FL 32779, and the immediate vicinity.
4. How does your 503B status ensure medication quality?
As a 503B outsourcing facility, we are subject to rigorous FDA oversight. This includes compliance with cGMP, which mandates stringent testing of ingredients and finished products, environmental monitoring, and validated processes to ensure sterility, potency, and purity.
5. How can a healthcare provider at your location place an order?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will provide information on ordering procedures, available formulations, and delivery options for services at 2160 W State Road 434, Longwood, FL 32779.