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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing medications in larger batches for office use by healthcare practitioners or for distribution to hospitals and clinics, without patient-specific prescriptions.
The 503B Compounding Pharmacy model ensures that all medications prepared within our facility on W State Road 434 meet rigorous testing and quality assurance protocols as mandated by the FDA. This provides a critical component of the local healthcare infrastructure, supplying practitioners with access to medications that may be commercially unavailable or in short supply. The operations at our Longwood location are focused on reliability and consistency, providing healthcare professionals with the assurance that the medications they administer are produced under the most stringent regulatory oversight.
Our team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in the art and science of pharmaceutical compounding. The environment at our facility on W State Road 434 is meticulously controlled to ensure the integrity of every preparation. For healthcare providers seeking a trusted source for high-quality compounded medications for office use, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a pivotal resource. We encourage local practitioners to contact us to discuss their specific needs.
To learn more about the services provided by 503B Compounding Pharmacy or to place an order, please visit our website at or call us at (407)993-1381. Our team is ready to assist healthcare professionals with their compounding requirements.
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 registration requires compliance with Current Good Manufacturing Practices (cGMP), which includes stricter standards for quality control, testing, and reporting compared to traditional compounding pharmacies.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy prepares medications in bulk for "office use" by healthcare practitioners or for distribution to healthcare facilities. We do not compound patient-specific medications based on an individual prescription. Patients should contact their healthcare provider, who can then order from our facility on W State Road 434 for administration in their practice.
3. What types of medications does 503B Compounding Pharmacy at this location prepare?
Our facility on W State Road 434 in Longwood prepares a range of sterile and non-sterile compounded medications that are typically used by healthcare providers in clinical settings. This includes, but is not limited to, hormone preparations, sterile injectables, ophthalmics, and other formulations that may be on drug shortage lists or are not commercially available.
4. How can a healthcare provider at a local practice order from your facility?
Healthcare providers and facilities can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process, which is designed for healthcare professionals seeking compounded medications for office use from our location at 2160 W State Road 434.
5. Why should a healthcare provider choose 503B Compounding Pharmacy for compounded medications?
Choosing our 503B outsourcing facility at 2160 W State Road 434 provides assurance of receiving medications produced under the highest federal quality and safety standards. Our compliance with cGMP regulations means every batch is rigorously tested for potency, sterility, and purity, offering a level of quality control that is essential for patient safety in a clinical setting.