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 large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare providers with access to medications that are not commercially available or are in shortage.
The 503B Compounding Pharmacy model ensures that all medications prepared at our Longwood location are produced under rigorous quality control standards. This includes undergoing testing for potency, sterility, and endotoxins. Our state-of-the-art facility on W State Road 434 is designed to meet the strict regulatory requirements set forth by the FDA, providing healthcare professionals with the assurance that the medications they receive are of the highest quality and reliability.
Our primary service is the compounding of medications in anticipation of receiving prescriptions, which allows us to supply healthcare providers with essential drugs for office use. The 503B Compounding Pharmacy at 2160 W State Road 434 serves a critical role in the local healthcare ecosystem by providing medications that are often on national shortage lists, ensuring that patient care in Longwood is not interrupted. We work directly with physicians, hospitals, and clinics to meet their specific medication needs.
Operating from our specific location in Longwood, we focus on the precise and accurate preparation of compounded medications. The 503B Compounding Pharmacy is equipped with advanced technology and staffed by experienced pharmacists and technicians who are experts in the art and science of compounding. Our commitment is to support the local medical community by being a reliable source for high-quality, compounded pharmaceutical products.
For more information about the services provided by 503B Compounding Pharmacy, you can visit our website at or contact us directly by phone at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to assist healthcare providers with their compounding needs.
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 FDA and complies with Current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet rigorous federal standards for quality, purity, and strength.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners. We supply medications directly to physicians, clinics, and hospitals for administration to their patients at their practice located at 2160 W State Road 434, Longwood, FL 32779.
3. Does 503B Compounding Pharmacy compound medications for individual patients?
No, 503B Compounding Pharmacy operates as an outsourcing facility under Section 503B. We compound medications in large batches for office use by healthcare providers, not for individual patient-specific prescriptions.
4. What types of medications does 503B Compounding Pharmacy prepare?
At our Longwood facility, we specialize in compounding both sterile and non-sterile medications that are often on drug shortage lists or are not available from traditional manufacturers, providing a critical supply for local healthcare providers.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 will assist with the ordering process.