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 quality and safety, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving our facility meets stringent federal requirements for strength, quality, and purity.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals in Longwood can rely on our facility for a consistent, high-quality supply of essential medications for their practice. This allows healthcare providers to have the necessary medications on hand for immediate administration to patients during procedures, treatments, or office visits, enhancing patient care and convenience. Our operations are distinct from a traditional retail pharmacy, as we primarily serve the needs of the medical community rather than dispensing directly to individual patients on a prescription-by-prescription basis.
Our state-of-the-art facility at 2160 W State Road 434 is designed to support a wide range of compounding needs. We specialize in sterile preparations, which are critical for injections, infusions, ophthalmic use, and other parenteral routes of administration. The environment in which these medications are produced is meticulously controlled to prevent microbial contamination, ensuring patient safety. Our highly trained staff of pharmacists and technicians utilizes advanced technology and precise processes to compound medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers.
503B Compounding Pharmacy is committed to supporting the local healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779. By providing healthcare practitioners with access to reliable, FDA-registered compounded medications, we play a vital role in the continuum of patient care. Our team works closely with medical providers to understand their specific needs and to ensure a seamless supply chain for their practices. For more information or to discuss your office use needs, please contact us at our website or by phone at (407)993-1381.
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 under Section 503B of the FD&C Act. We are subject to federal oversight and must comply with Current Good Manufacturing Practices (cGMP), which are the same stringent quality standards required of large-scale pharmaceutical manufacturers. This ensures a higher level of quality control and consistency for the compounded medications we produce.
2. Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily supplies compounded medications for office use to healthcare practitioners with prescribing authority. This includes physicians, surgeons, dermatologists, and other medical professionals who administer medications within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not typically dispense medications directly to individual patients based on a personal prescription.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in preparing both sterile and non-sterile compounded medications in larger, bulk quantities. This includes sterile injectables, ophthalmic solutions, and other preparations that are essential for healthcare providers to have in stock for procedures and treatments performed at their practices serving the 2160 W State Road 434, Longwood, FL 32779 location.
4. How does using a 503B outsourcing facility benefit my medical practice?
Utilizing our services at 2160 W State Road 434 ensures your practice has access to high-quality, reliable medications that are compounded under the strictest federal standards. This mitigates the risk of drug shortages from traditional manufacturers and provides a trusted source for medications that are critical for your procedures, ultimately enhancing patient safety and care at your practice.
5. How can I order compounded medications for my practice?
Healthcare practitioners can initiate orders or inquire about our services by contacting 503B Compounding Pharmacy directly. You can reach our facility located at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381. Our team will guide you through the process and discuss your specific office use requirements.