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, providing medications for healthcare providers to administer to their patients in a professional clinical setting or for patient-specific dispensing.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded drugs. This process is conducted under rigorous quality control protocols that are mandated by the FDA. The medications prepared at our Longwood facility are intended for use by physicians, clinics, and hospitals, ensuring they have access to essential drugs that may be in shortage or not commercially available. Our operations are distinct from traditional compounding, focusing on providing a bulk supply of medications without receiving individual patient prescriptions.
Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and maintained under controlled environmental conditions to ensure the integrity and sterility of every preparation. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who are experts in aseptic processing and quality assurance. We are committed to supporting the local medical community by providing a reliable source of high-quality compounded medications, thereby enhancing patient care and treatment outcomes.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly at (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is focused on serving the specific needs of healthcare professionals with precision and reliability.
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 strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures the medications we produce meet specific quality and safety benchmarks.
2. Who can order medications from 503B Compounding Pharmacy?
Medications are provided to healthcare professionals and entities, such as hospitals, clinics, and physician offices. We do not dispense medications directly to individual patients based on a prescription; instead, we supply medications in bulk for office use.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility prepares a range of sterile and non-sterile compounded medications. This often includes medications that are on drug shortage lists or are not available from commercial manufacturers, providing a critical supply for healthcare providers.
4. How does the quality control process work at your facility?
Quality control is integral to our operation. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing and validation processes to ensure sterility, potency, and purity before it is released for distribution.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will provide information on ordering procedures, available medications, and delivery options specific to our location.