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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), providing healthcare providers and patients with the assurance that our preparations meet stringent federal quality standards.
At our location on 2160 W State Road 434, Longwood, FL 32779, we specialize in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. Our primary focus is on producing preparations that are often in short supply or not commercially available, thereby playing a critical role in patient care within our community. The medications produced at this facility are formulated without commercially available alternatives or are necessary for patients who have specific medical needs that cannot be met by an FDA-approved drug.
The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who utilize state-of-the-art equipment and technology within our controlled environment at 2160 W State Road 434, Longwood, FL 32779. Every process, from ingredient sourcing to final product testing, is meticulously controlled and documented to ensure potency, purity, and sterility. Our facility provides healthcare professionals in the area with a reliable and trusted source for high-quality compounded medications, supporting them in delivering optimal therapeutic outcomes for their patients.
For more information about the services provided directly from our facility, please visit our website at or contact us by phone at (407)993-1381. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the highest principles of pharmaceutical compounding under federal law.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under strict federal regulations known as current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and testing for the medications we compound compared to a traditional pharmacy.
2. Can I, as a patient, pick up my medication directly from your location?
No. As a 503B outsourcing facility, our primary function is to supply compounded medications for office use by healthcare providers. Your prescribing physician or clinic would order and receive the medication from us at 2160 W State Road 434, Longwood, FL 32779, and then administer it to you during your appointment.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectables, ophthalmics, and other preparations that are often on drug shortage lists or are not available from commercial manufacturers. We provide these in larger batches for healthcare practitioners.
4. How can my medical practice order from your facility?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will guide you through the process, which includes establishing an account and providing necessary documentation.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing our 503B facility at 2160 W State Road 434, Longwood, FL 32779 provides assurance of receiving medications produced under the highest quality standards mandated by the FDA. This reduces risk and provides confidence in the sterility, potency, and purity of the compounded preparations used in patient care.