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 current good manufacturing practices (cGMP), which distinguishes our operations and ensures a level of quality, consistency, and safety beyond traditional compounding standards. Our mission is to provide healthcare providers with access to essential medications that are often on shortage or unavailable from conventional pharmaceutical manufacturers, directly serving the needs of the local medical community from our specific location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications for office use. This means physicians and healthcare practitioners in Longwood can obtain vital medications for immediate administration to patients within their practice settings. Our facility at 2160 W State Road 434, Longwood, FL 32779 prepares batches of medications without receiving patient-specific prescriptions, which are then distributed to healthcare facilities for office stock. This model is crucial for ensuring that clinics and practices have the necessary medications on hand for treatments, procedures, and emergency care, enhancing the efficiency and effectiveness of local patient care.
Our services are defined by our regulatory status as a 503B outsourcing facility. We engage in the compounding of sterile preparations, which are medications intended to be administered through injections, infusions, or applied to the eye. This includes solutions, suspensions, and emulsions that must be prepared in a meticulously controlled environment to ensure they are free from contaminants. Our facility is designed with state-of-the-art cleanrooms and environmental monitoring systems to guarantee the sterility and stability of every preparation that leaves our location. Additionally, we compound non-sterile medications, which are used in various other treatment protocols. All processes are governed by rigorous testing, quality control measures, and strict adherence to cGMP regulations.
503B Compounding Pharmacy provides these medications directly to healthcare entities. Our primary point of contact is with licensed practitioners, including physicians, surgeons, and other healthcare providers, who utilize our compounded products within their practice at 2160 W State Road 434, Longwood, FL 32779. We are a vital partner to the local medical community, helping to mitigate drug shortages and provide reliable access to critical medications. For more information about our services or to discuss your facility's needs, you can visit our website at or contact us directly 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 complies with Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to follow current good manufacturing practices (cGMP) for the compounding of medications, which includes rigorous testing, quality control, and adherence to strict sterility standards for our preparations.
2. Who can order medications from 503B Compounding Pharmacy?
Medications are supplied to licensed healthcare practitioners for office use within their practice. This includes physicians, surgeons, and other qualified medical professionals who administer medications to patients in a clinical setting. We serve these healthcare providers directly from our location at 2160 W State Road 434, Longwood, FL 32779.
3. Does 503B Compounding Pharmacy fill individual patient prescriptions?
No. As a 503B outsourcing facility, our primary function is the large-scale compounding of medications for office stock. We do not compound medications based on individual patient prescriptions. Our products are supplied to healthcare facilities for use by practitioners during treatments and procedures.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our facility compounds both sterile and non-sterile medications. Sterile preparations include injectables, infusions, and ophthalmic solutions. Non-sterile preparations include various other dosage forms. All medications are compounded in batches under cGMP standards at our location on W State Road 434.
5. How can a healthcare provider place an order or get more information?
Healthcare providers interested in our services can obtain more information or initiate an order by contacting 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website at . Our team is available to discuss your specific medication needs for your practice.