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 current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous standards for sterility, potency, and purity. This designation differentiates us from traditional compounding pharmacies and underscores our commitment to providing healthcare providers with medications they can trust for their patients.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. We supply healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with essential medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers. Our services are vital for medical offices, surgery centers, and clinics, enabling them to have critical drugs readily available for procedures and patient treatments without the burden and regulatory complexity of in-house compounding. We provide a reliable, compliant source for these necessary medications.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists and technicians. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This unwavering focus on quality control and regulatory compliance is the foundation of our operation. Healthcare professionals who utilize our services can be confident that the medications they receive are produced under the most stringent quality assurance protocols, providing the utmost safety for patient care.
503B Compounding Pharmacy serves as a crucial partner to the local medical community. By outsourcing their compounding needs to our facility at 2160 W State Road 434, Longwood, FL 32779, healthcare providers can reallocate valuable time and resources directly to patient care, knowing their medication supply is managed by experts. We are committed to supporting the health infrastructure of our immediate area through reliability, quality, and a dedicated focus on the specific requirements of Section 503B compliance.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly by phone at (407)993-1381. Our team is available to assist healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with their specific medication needs.
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 operating under Section 503B. We compound large volumes of sterile medications for office use by healthcare practitioners and must comply with strict federal current good manufacturing practices (cGMP).
2. Can I, as an individual patient, get a prescription filled at this location?
No. 503B Compounding Pharmacy provides medications for office use to healthcare providers and practices. Individual patients should contact a traditional 503A compounding pharmacy for their personal prescription needs.
3. What types of medications does this 503B facility typically prepare?
We specialize in compounded sterile preparations (CSPs), which can include injectables, IV bags, ophthalmics, and other medications that are often on drug shortage lists or are needed in specific strengths not commercially available for healthcare providers at our location.
4. How does a medical practice at this address order from your 503B facility?
Healthcare providers and practices can establish an account with our facility by contacting us directly. Orders can be placed by calling (407)993-1381. Our team will guide you through the process specific to 503B outsourcing.
5. Why should a clinic use a 503B outsourcing facility instead of compounding in-house?
Utilizing our 503B facility at 2160 W State Road 434, Longwood, FL 32779 eliminates the significant regulatory burden, equipment costs, and validation processes required for a practice to perform its own sterile compounding. It ensures compliance and provides access to rigorously tested medications.