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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, sterility, and potency, providing healthcare providers with medications they can trust for their patients.
The 503B Compounding Pharmacy model is distinct from traditional compounding. Our operation at 2160 W State Road 434, Longwood, FL 32779 is subject to rigorous current Good Manufacturing Practices (cGMP) as mandated by the FDA. This ensures every batch of medication produced within our facility undergoes stringent testing and quality assurance protocols. We serve healthcare providers by producing large quantities of compounded sterile preparations (CSPs) and non-sterile preparations for office use, eliminating the need for individual practitioner compounding.
Our core service at 2160 W State Road 434, Longwood, FL 32779 is the large-scale compounding of medications for office use by healthcare practitioners. This includes a wide range of sterile injectables, ophthalmics, and other preparations that are essential for clinics, hospitals, and surgical centers. By relying on our 503B outsourcing facility, healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can be assured of receiving medications that meet the highest standards of pharmaceutical quality, safety, and consistency.
The team at our 503B Compounding Pharmacy location is comprised of highly skilled pharmacists and technicians who are experts in sterile and non-sterile compounding techniques. Every process within the facility at 2160 W State Road 434, Longwood, FL 32779 is meticulously controlled and documented, from ingredient sourcing to final packaging. We are committed to supporting the local medical community by providing a reliable, compliant source of high-quality compounded medications.
For healthcare providers seeking a trusted 503B outsourcing facility partner, we are located at 2160 W State Road 434, Longwood, FL 32779. You can learn more about our compliance and services by visiting our website at or by calling us directly at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
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 an FDA-registered outsourcing facility that operates under Section 503B of the FD&C Act. We are required to comply with strict current Good Manufacturing Practices (cGMP) for the production of compounded medications, ensuring a higher level of regulatory oversight for sterility, potency, and quality control compared to a traditional 503A pharmacy.
2. Can I, as a patient, order medication directly from your 503B facility?
No. As a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we provide medications for office use by healthcare practitioners. Patients must receive 503B compounded medications through their doctor, clinic, or hospital. We do not dispense medications directly to individual patients.
3. What types of medications does the 503B Compounding Pharmacy at this location produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in producing large batches of compounded sterile preparations (CSPs), such as injectables, ophthalmics, and irrigation solutions. We also compound non-sterile medications. All our products are intended for office use by healthcare providers serving patients at their practice locations.
4. How does the quality control at a 503B outsourcing facility differ?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 follows enforced cGMP standards. This includes rigorous testing of incoming ingredients, environmental monitoring of our cleanrooms, sterility testing on finished products, and stability studies to ensure potency and purity throughout a medication's shelf life. This level of testing is a fundamental requirement of our FDA-registered status.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your facility?
Healthcare providers can establish an account with our 503B outsourcing facility by contacting us. For ordering information and to discuss your practice's specific needs, please visit our website at or call our facility directly at (407)993-1381.