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 FDA's Current Good Manufacturing Practices (cGMP), ensuring the highest standards of quality, purity, and potency for all medications we produce. This regulatory framework distinguishes our operations and provides healthcare providers and patients with the assurance of receiving medications that meet rigorous federal quality standards.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are not commercially available. This includes creating formulations without certain allergens, dyes, or preservatives, or producing medications that have been discontinued by major manufacturers. Our work directly supports healthcare providers at 2160 W State Road 434, Longwood, FL 32779 by providing access to essential medications tailored to specific patient needs that cannot be met by standard commercial products. All our processes are conducted within our state-of-the-art cleanroom environment at this location to ensure sterility and safety.
Our services are exclusively provided from our facility at 2160 W State Road 434, Longwood, FL 32779. We do not operate retail storefront services; instead, we work directly with healthcare providers who prescribe these necessary medications. Patients who require compounded medications from our pharmacy should consult with their healthcare provider to determine if a compounded prescription from an FDA-registered 503B outsourcing facility is appropriate for their treatment plan. The prescribing provider can then coordinate directly with our facility to fulfill the medication order.
Quality control is the foundation of everything we do at 503B Compounding Pharmacy. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 undergoes stringent testing and quality assurance protocols. This includes stability testing, sterility testing, and endotoxin testing for our sterile preparations. Our commitment to cGMP standards ensures that every prescription leaving our facility is of the highest quality and reliability, providing critical support for patient care in our community.
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 is available to assist healthcare professionals with inquiries regarding our compounding capabilities, regulatory compliance, and the ordering process from our location at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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 complies with strict federal standards known as Current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet rigorous quality, sterility, and potency controls.
2. As a patient, how do I obtain a medication from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications directly to healthcare providers and institutions, not individual patients at a retail counter. Your healthcare provider must determine the medical necessity for a compounded medication and will place the order directly with our facility at 2160 W State Road 434, Longwood, FL 32779 on your behalf.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our FDA-registered outsourcing facility specializes in compounding sterile injectable medications, including IV bags, ophthalmics, and other preparations that require an aseptic environment. We produce these medications in larger batches for healthcare providers, adhering to cGMP standards for safety and quality.
4. How does the quality assurance process work at your facility?
Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes a comprehensive quality control process. This includes testing for sterility, potency, and endotoxins by our quality control department to ensure it meets all specifications before being released for distribution.
5. Who should I contact for more information about your services?
Healthcare providers can contact 503B Compounding Pharmacy directly for more information. Please call us at (407)993-1381 or visit our website at . Our facility is located at 2160 W State Road 434, Longwood, FL 32779.