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. We serve a critical role for healthcare providers and patients by producing medications that are not commercially available, ensuring specific patient needs are met with the highest standards of quality and safety.
The 503B outsourcing facility designation signifies that our pharmacy adheres to rigorous current good manufacturing practices (cGMP). This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent federal standards for potency, purity, and sterility. Our processes are subject to regular FDA inspections, providing an additional layer of assurance for the healthcare community we serve.
Our core service is the large-scale compounding of medications for office use by healthcare practitioners. Physicians and clinics can utilize our services to obtain necessary medications for their practice, ensuring they have the right preparations on hand for patient treatments. This model supports efficient clinic operations and enhances patient care by providing access to essential medications that are tailored to specific clinical applications.
We provide essential pharmaceutical preparations for a variety of medical needs. This includes compounded sterile preparations (CSPs) such as injections, ophthalmic drops, and irrigation solutions. Our work is conducted in controlled environments by highly trained personnel to ensure patient safety. We maintain a steadfast commitment to the principles of quality and compliance that define a 503B outsourcing facility.
Contact 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 for more information. You can reach us via phone at (407)993-1381 or visit our website at . Our team is prepared to support healthcare providers with their compounding needs.
Frequently Asked Questions
What does it mean that you are 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 Section 503B of the FD&C Act. We follow current good manufacturing practices (cGMP) and are subject to regular FDA inspections, which allows us to compound medications on a larger scale for office use by healthcare practitioners.
Who can order medications from your facility?
We provide compounded medications for office use to licensed healthcare practitioners. Patients must work with their healthcare provider, who can then place an order with our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we prepare a range of sterile compounded medications, including injectables, ophthalmic solutions, and other preparations that are essential for healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at your facility?
Our quality assurance process is governed by strict cGMP standards. Every batch of medication compounded at our location undergoes rigorous testing and validation to ensure it meets specified standards for identity, strength, quality, and purity before it is released.
How can a healthcare provider place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. Our facility is located at 2160 W State Road 434, Longwood, FL 32779.