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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility adheres to the most rigorous current good manufacturing practices (cGMP) mandated by the FDA. This ensures that every preparation leaving the facility meets the highest standards of quality, purity, and potency for the patients and healthcare providers it serves.
The core function of 503B Compounding Pharmacy is the large-scale, non-patient-specific compounding of sterile and non-sterile medications. As an outsourcing facility, it prepares medications in advance of receiving a prescription, based on historical demand data from healthcare providers. This model allows for a consistent and reliable supply of essential medications that may be on shortage or are not commercially available. The medications produced are then distributed to healthcare facilities and prescribers for administration to their patients, ensuring timely access to critical treatments.
The team at 503B Compounding Pharmacy comprises highly skilled pharmacists and technicians who are experts in the science of compounding within a cGMP environment. The facility at 2160 W State Road 434 is equipped with state-of-the-art technology, including advanced environmental monitoring systems and ISO-classified cleanrooms, to guarantee the sterility and safety of all injectable and other sterile preparations. Every batch undergoes stringent testing and quality control checks before it is released, providing an unparalleled level of assurance.
Healthcare providers who partner with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be confident they are sourcing medications from a trusted, compliant, and quality-focused outsourcing facility. The pharmacy is dedicated to supporting the local medical community by providing a vital link in the supply chain for essential medications. For more information or to discuss your facility's needs, you can contact 503B Compounding Pharmacy via their website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means our facility at 2160 W State Road 434 is registered with the FDA and operates under strict federal regulations known as current good manufacturing practices (cGMP). This is different from a traditional 503A pharmacy, as we compound medications on a larger scale without receiving individual patient prescriptions beforehand.
2. Who can receive medications from 503B Compounding Pharmacy?
Medications are distributed to healthcare providers and facilities, such as hospitals, clinics, and physician offices. These healthcare professionals then administer the medications to their patients under their care. We do not dispense medication directly to individual patients at our location on W State Road 434.
3. What types of medications does 503B Compounding Pharmacy prepare?
We specialize in compounding sterile injectable medications that are often on drug shortage lists or are not commercially available from large pharmaceutical manufacturers. This includes a wide range of preparations vital for patient care in various clinical settings.
4. How does the quality assurance process work at your facility?
Our quality assurance is rigorous and multi-layered. It includes extensive testing of components, in-process testing, and finished preparation potency, sterility, and endotoxin testing. Our cleanrooms are continuously monitored to ensure they meet ISO standards for particulate and microbial counts.
5. How can a healthcare facility at 2160 W State Road 434 order from you?
Healthcare facilities and providers can establish an account with our 503B outsourcing facility. For ordering information and to discuss your specific needs, please contact our team directly at (407)993-1381 or visit our website at .