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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical compounding, including current Good Manufacturing Practices (cGMP), which ensures every preparation meets rigorous quality and safety protocols. Our mission is to provide healthcare providers with access to essential medications that are not commercially available, thereby supporting patient care directly from our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. This process is conducted for office use by healthcare practitioners, allowing them to have vital medications on hand for immediate patient needs. The medications prepared at our 2160 W State Road 434 facility are distributed to healthcare providers for administration within their professional practice settings. This model is fundamental to the 503B outsourcing facility designation, distinguishing our operations from traditional retail compounding pharmacies and ensuring a consistent supply of high-quality medications.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and maintained under stringent environmental controls. This infrastructure supports our commitment to producing sterile injectables, ophthalmics, and other complex dosage forms with the utmost precision and sterility assurance. Every batch of medication is subject to rigorous testing and quality control measures before it is released, providing healthcare professionals with the confidence that they are using products of the highest integrity for their patients in the local area.
503B Compounding Pharmacy serves as a critical partner for local healthcare providers, including hospitals, clinics, and surgical centers. By supplying them with FDA-registered, office-use medications from our location at 2160 W State Road 434, we help ensure that practitioners have the necessary tools to deliver effective and timely care. Our dedicated team of pharmacists and technicians is committed to excellence in every aspect of the compounding process, from sourcing quality ingredients to the final packaging and labeling of our products.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at . We are located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of medications for office use by healthcare practitioners, adhering to strict federal quality standards including current Good Manufacturing Practices (cGMP).
2. Can I, as an individual patient, pick up my prescription at your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. Individual patient prescriptions are typically handled by traditional retail pharmacies. Our services are dedicated to supplying practitioners from our facility at 2160 W State Road 434.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectables, ophthalmics, and other non-sterile preparations that are distributed to healthcare providers for use within their practice.
4. How does a healthcare provider order from your pharmacy?
Healthcare providers can place orders for compounded medications by contacting our facility directly at (407)993-1381. Our team will provide information on ordering procedures and product availability from our location at 2160 W State Road 434.
5. Why is using an FDA-registered 503B outsourcing facility important?
It ensures that the medications are produced under the highest level of regulatory oversight, which includes compliance with cGMP for consistent quality, strength, and purity. This provides an added layer of safety for healthcare providers and their patients using medications from our Longwood facility.