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 pharmaceutical compounding, including current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility meets rigorous quality and safety protocols for potency, purity, and sterility.
The 503B Compounding Pharmacy model is distinct from traditional compounding. Our status as an FDA-registered outsourcing facility means we compound medications in larger batches for office use, which are then distributed to healthcare practitioners for patient administration within their practices. The medications prepared at our location on W State Road 434 are essential for many healthcare providers, including hospitals, clinics, surgical centers, and physician offices, enabling them to have a reliable supply of critical drugs.
Our services at 2160 W State Road 434 are focused on the needs of the medical community. We provide a vital resource for practitioners who require medications that are not commercially available or are experiencing a shortage. The 503B Compounding Pharmacy team is comprised of skilled pharmacists and technicians who utilize advanced technology and stringent quality control measures to produce preparations that healthcare providers can trust implicitly for their patients.
Quality assurance is the cornerstone of our operation at this facility. Every step of the compounding process, from sourcing ingredients to final packaging, is meticulously controlled and documented. This unwavering commitment to quality ensures that the preparations provided by 503B Compounding Pharmacy are of the highest caliber, providing practitioners and their patients with confidence and peace of mind.
For more information about the services provided directly from our facility at 2160 W State Road 434, Longwood, FL 32779, please contact us. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our team is prepared to assist healthcare providers with their specific medication needs.
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 FDA and operates under Section 503B of the FD&C Act. We comply with current Good Manufacturing Practices (cGMP) and are subject to regular FDA inspections, which ensures a higher level of regulatory oversight for the sterile and non-sterile preparations we compound.
2. Can I as an individual patient pick up my prescription directly from the 503B Compounding Pharmacy location?
No. As a 503B outsourcing facility, we primarily compound medications for office use by healthcare practitioners. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. Our preparations are distributed to hospitals, clinics, and doctor's offices located near our facility at 2160 W State Road 434.
3. What types of preparations does 503B Compounding Pharmacy provide from this location?
Our facility on W State Road 434 specializes in compounding a range of preparations, including sterile injectables, ophthalmics, and other medications that are often on drug shortage lists. We provide these in larger batches for healthcare providers to have on hand for patient care within their practice settings.
4. How does a healthcare provider at a local clinic order from 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs. Orders can be placed by calling our facility at (407)993-1381. Our team will work with the provider to fulfill their request for compounded medications from our location at 2160 W State Road 434.
5. How does 503B Compounding Pharmacy ensure the quality of its preparations?
Quality is ensured through strict adherence to cGMP guidelines. This includes rigorous testing of ingredients, environmental monitoring of our cleanrooms, validation of sterilization processes, and thorough quality control testing on finished preparations before they are released from our facility at 2160 W State Road 434, Longwood, FL 32779.