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 quality control, sterility, and potency, providing a critical service for patients whose medical needs cannot be met by commercially available FDA-approved drugs.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. This means healthcare practitioners at medical facilities can utilize our medications for immediate administration to patients within their practice. Our operations are distinct from traditional compounding, as we are subject to rigorous FDA oversight, current Good Manufacturing Practices (cGMP), and mandatory reporting of adverse events. This regulatory framework ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets an exceptional level of safety and reliability.
Our services are essential for hospitals, surgical centers, clinics, and other healthcare providers that require access to ready-to-use, high-quality medications. We provide a vital supply of medications that may be in short supply or discontinued by major manufacturers, helping to prevent treatment delays for patients. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize state-of-the-art equipment and technology within our controlled environment to ensure the integrity of every preparation.
Patients and healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can have full confidence in the medications we produce. Our commitment is to uphold the stringent regulations that define a 503B outsourcing facility, providing a dependable and critical component of the local healthcare infrastructure. For more information on how we can support your practice, please contact us directly.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. This subjects us to more rigorous federal standards, including cGMP, than a traditional compounding pharmacy, ensuring a higher level of quality control and sterility assurance for the medications we produce at our location on W State Road 434.
2. Can I as an individual patient pick up my prescription directly from your facility?
No. 503B Compounding Pharmacy primarily prepares medications for office use by healthcare providers. Individual patient-specific prescriptions are typically handled by traditional 503A compounding pharmacies. Our services are designed to supply medications in bulk to hospitals, clinics, and other medical practices for their use.
3. How does the 503B model benefit my local doctor's office or clinic?
It provides your healthcare provider with immediate access to high-quality, sterile medications that are often on shortage or unavailable from large manufacturers. This allows them to treat patients promptly without delays, using preparations that have been made under the strictest FDA-enforced quality standards right here in Longwood.
4. Are the medications from a 503B outsourcing facility safe?
Yes. Safety is the foundation of the 503B model. Our facility undergoes regular FDA inspections and must comply with current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This includes extensive testing of components, environmental monitoring, and validation of sterilization processes.
5. How can a medical practice at 2160 W State Road 434 order from you?
Healthcare providers and facilities can establish an account with 503B Compounding Pharmacy by contacting our team directly. We will guide you through the simple process. You can reach us for ordering information and questions at (407)993-1381 or via our website at .