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. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP) and are subject to regular FDA inspections, providing an additional layer of assurance for the medications we produce.
The services provided by 503B Compounding Pharmacy at our location on 2160 W State Road 434 are distinct from traditional compounding. We engage in large-scale, non-patient-specific compounding. This means we produce compounded medications in bulk for healthcare facilities, which then dispense them to their patients pursuant to a patient-specific prescription. Our core mission is to support the local medical community by providing them with access to high-quality, sterile and non-sterile compounded preparations that are often unavailable from conventional pharmaceutical manufacturers.
Our facility at 2160 W State Road 434 is equipped with state-of-the-art technology and maintained under strict environmental controls to ensure the integrity of every preparation. Our team of highly trained pharmacists and technicians follows exacting protocols for every batch, which includes comprehensive testing and stringent quality control measures. By focusing on bulk compounding, 503B Compounding Pharmacy helps to alleviate drug shortages, provides essential medications for office use, and contributes to the efficiency of healthcare delivery for practitioners serving patients from our location.
For healthcare providers and facilities seeking a reliable source for bulk compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a trusted partner. We encourage you to contact us to discuss your specific needs. You can reach us by phone at (407)993-1381 or visit our website for more information at .
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 in compliance with Section 503B of the FD&C Act. We are subject to federal oversight, including routine FDA inspections, and must adhere to current good manufacturing practices (cGMP), which are the strict quality standards required of major pharmaceutical manufacturers.
2. Can I, as an individual patient, get a prescription filled directly at 2160 W State Road 434?
No. 503B Compounding Pharmacy is an outsourcing facility that compounds medications in bulk for healthcare facilities and practitioners. Individual patients must receive their medications through their prescribing doctor's office or a clinic that has sourced the medication from our facility. We do not dispense directly to the public from our location.
3. What types of medications does 503B Compounding Pharmacy produce at its Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434 specializes in compounding a wide range of sterile and non-sterile preparations in bulk quantities. This includes, but is not limited to, hormone replacement therapies, sterile injectables, ophthalmics, and other formulations that are on shortage or are not commercially available for healthcare providers.
4. How does a medical practice or hospital order from your facility?
Healthcare facilities and licensed practitioners can establish an account with 503B Compounding Pharmacy by contacting us directly. Our team will guide you through the onboarding process. You can initiate this by calling our facility at (407)993-1381. Orders are typically placed by authorized personnel from the healthcare facility.
5. Why would a healthcare provider choose a 503B outsourcing facility over a traditional 503A pharmacy?
Healthcare providers sourcing from our location at 2160 W State Road 434 choose a 503B outsourcing facility for the enhanced level of regulatory oversight and quality control. The cGMP standards and federal inspection requirements provide an added assurance of product quality, sterility, and strength, which is particularly critical for office-use medications and medications administered within a clinical setting.