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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike traditional compounding pharmacies, this 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), which are the same standards followed by major pharmaceutical manufacturers. This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent specifications for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. This means healthcare practitioners at practices and facilities can order these medications in bulk for administration to their patients within their clinical settings. The medications produced are typically those that are on the FDA’s drug shortage list or are not commercially available from standard pharmaceutical companies. By providing these essential medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 serves as a critical partner to the local medical community, helping to ensure patient care is not interrupted by supply chain issues.
Operations at this specific location are defined by a robust quality control framework. Every batch of medication is subjected to thorough testing and validation processes. This includes sterility testing, endotoxin testing, and analytical verification of potency to guarantee that each preparation is safe and effective for patient use. The environment at 2160 W State Road 434, Longwood, FL 32779 is a controlled, cleanroom space where air quality, temperature, and humidity are constantly monitored to prevent contamination. This meticulous attention to detail is a fundamental requirement of the 503B outsourcing facility designation and is central to the mission of this pharmacy.
503B Compounding Pharmacy provides a vital service from its facility at 2160 W State Road 434, Longwood, FL 32779. It enables healthcare providers to access necessary medications that are otherwise unavailable, directly supporting the health and well-being of their patients. The pharmacy’s role is to act as a reliable, high-quality manufacturer for the medical community, ensuring that practitioners have the tools they need to deliver effective treatments. For more information or to inquire about services, please contact 503B Compounding Pharmacy at their website, , or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare providers. It operates under stricter federal regulations (cGMP) than a traditional compounding pharmacy.
2. Can I, as an individual patient, pick up a prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy primarily supplies medications in bulk for office use to healthcare practitioners. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. This location focuses on serving the needs of medical practices and facilities.
3. What types of medications does this 503B outsourcing facility prepare?
The facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding medications that are on the FDA drug shortage list or are not commercially available. This often includes sterile injectables, IV preparations, and other medications required for use in clinical settings.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers and facilities can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. The team will provide information on available medications, ordering procedures, and delivery options specific to this location.
5. Why is the 503B designation important for quality?
The 503B designation requires the facility to comply with current good manufacturing practices (cGMP). This ensures every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for sterility, potency, and purity, providing a higher assurance of safety for patients.