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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring every preparation meets exacting specifications for the healthcare providers and patients we serve at our Longwood location.
The core service of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are distributed to healthcare facilities for office use. Our operations at 2160 W State Road 434 are specifically designed to support physicians, surgeons, dermatologists, oncologists, and other medical professionals in the area by providing them with ready-to-use, high-quality medications that are often unavailable from commercial manufacturers. This includes a range of preparations such as sterile injectables, ophthalmics, topicals, and other dosage forms essential for modern medical practice.
By focusing on non-patient-specific, office-use compounding, 503B Compounding Pharmacy provides a critical supply chain solution for local clinics and practices. This allows healthcare providers at our location to maintain an inventory of essential medications without the burden and regulatory complexity of compounding them in-house. Our processes are meticulously controlled, from sourcing high-purity active pharmaceutical ingredients (APIs) to employing advanced environmental monitoring and finished product testing, providing assurance to the medical community at 2160 W State Road 434, Longwood, FL 32779.
Our facility is equipped with state-of-the-art technology, including ISO-classified cleanrooms for sterile compounding, to ensure the integrity and safety of every preparation. The team at 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals dedicated to upholding the principles of cGMP. We are a pivotal resource for the local medical community, enabling providers to enhance patient care with confidence through reliable access to compounded medications. For more information or to discuss your office-use needs, please contact us via our website at or by phone at (407)993-1381.
FAQ
1. What does it mean that you are a 503B outsourcing facility?
Being a 503B outsourcing facility means we are an FDA-registered entity that compounds medications in large volumes for office use by healthcare providers. We operate under stricter federal regulations, including current Good Manufacturing Practices (cGMP), which ensures a higher level of quality control, testing, and oversight compared to traditional pharmacies.
2. Can I, as a patient, pick up my personal prescription at your location?
No. 503B Compounding Pharmacy does not compound patient-specific prescriptions. Our services are exclusively for healthcare providers and their office-use needs. Patients should contact their prescribing physician or a traditional compounding pharmacy for their individual medications.
3. What types of medications do you compound for healthcare providers at your facility?
We compound a wide array of sterile and non-sterile preparations, including injectables, ophthalmics, dermatological creams, and other formulations. These are supplied to local clinics and practices for administration to patients within their care settings at 2160 W State Road 434, Longwood, FL 32779.
4. How do I, as a healthcare provider, order compounded medications from your facility?
Healthcare providers can establish an account with us by contacting our office directly. Orders can be placed through our dedicated systems. Please reach out to our team at (407)993-1381 or via our website at to begin the process.
5. Why should a practice at your location use a 503B facility instead of compounding in-house?
Utilizing our 503B facility eliminates the significant capital investment, stringent environmental control requirements, and extensive regulatory compliance burden associated with in-house compounding. We provide guaranteed quality, rigorous testing, and compliance, allowing providers to focus on patient care.