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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are a specialized pharmacy located at 2160 W State Road 434, Longwood, FL 32779, dedicated to the large-scale compounding of sterile and non-sterile medications. Unlike traditional pharmacies, our 503B status signifies our adherence to the most rigorous federal standards for quality, safety, and production control. This ensures that every preparation leaving our facility meets stringent testing and beyond-use dating requirements, providing healthcare providers and patients with the highest level of confidence in their medications.
Our core service at our Longwood facility is the production of compounded medications in bulk for office use by healthcare practitioners. We serve hospitals, clinics, surgical centers, and other healthcare providers who require ready-to-administer, patient-specific medications. By outsourcing their compounding needs to our 503B Compounding Pharmacy, these practices can enhance patient safety, improve operational efficiency, and ensure regulatory compliance. Our team of highly trained pharmacists and technicians utilizes state-of-the-art technology and cleanroom environments to compound a wide array of preparations, including intravenous (IV) bags, hormone therapy injections, ophthalmic solutions, and other essential sterile products.
We are committed to supporting the local medical community at 2160 W State Road 434, Longwood, FL 32779 by providing a reliable and compliant source for high-quality compounded medications. Our processes are designed for accuracy and sterility, from the sourcing of pure, high-quality active pharmaceutical ingredients (APIs) to the final packaging and labeling. For healthcare providers seeking a trusted partner for their compounding needs, we invite you to contact 503B Compounding Pharmacy to learn more about our services and capabilities.
For more information, please visit our website at or call us at (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 registration requires us to comply with Current Good Manufacturing Practice (CGMP) regulations, which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures a higher level of quality control, sterility assurance, and product testing for all medications we produce at our location on 2160 W State Road 434, Longwood, FL 32779.
2. Can I, as an individual patient, pick up my prescription directly from your facility?
No. 503B Compounding Pharmacy primarily produces medications in bulk for office use by healthcare providers. Individual patient prescriptions are typically compounded and dispensed through a traditional 503A pharmacy. Our services are designed to supply physicians, hospitals, and clinics at 2160 W State Road 434, Longwood, FL 32779 with medications they need to administer to patients within their practice.
3. What types of medications does 503B Compounding Pharmacy prepare?
We specialize in compounding sterile injectable medications, including IV bags, hormone injections, and other solutions for administration by healthcare professionals. Our focus is on producing these preparations in larger quantities to support the needs of the medical community we serve from our facility at 2160 W State Road 434, Longwood, FL 32779.
4. How does a healthcare provider at 2160 W State Road 434 order from you?
Healthcare providers can establish an account with 503B Compounding Pharmacy by contacting our team directly. We will work with you to understand your specific needs and requirements. Orders can be placed through our dedicated channels. Please contact us at (407)993-1381 to begin the process.
5. Why should a clinic use a 503B outsourcing facility instead of compounding in-house?
Utilizing our 503B Compounding Pharmacy eliminates the significant overhead, regulatory burden, and quality control challenges associated with in-house compounding. Our dedicated facility at 2160 W State Road 434, Longwood, FL 32779 is designed and maintained to meet strict FDA CGMP standards, providing assurance of sterility, potency, and purity. This allows clinics to focus on patient care while relying on us for consistent, high-quality compounded medications.