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, granted 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, an outsourcing facility like 503B Compounding Pharmacy is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving the facility meets stringent quality control measures for the healthcare providers and patients it serves at its Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. This means that healthcare practitioners in the vicinity of 2160 W State Road 434 can access a reliable, high-quality supply of essential medications without the need for in-office compounding. The facility provides these medications in bulk to physician offices, hospitals, clinics, and other healthcare entities, enabling them to have necessary drugs readily available for patient administration. This model supports local healthcare delivery by ensuring a consistent supply of medications that may be commercially unavailable or in short supply.
By focusing on non-patient-specific, office-use compounding, 503B Compounding Pharmacy addresses critical gaps in the pharmaceutical market. This includes producing preparations that are on the FDA drug shortage list, allowing continuous patient care even when mainstream manufacturers cannot meet demand. Furthermore, the facility can compound formulations that are not otherwise available from commercial manufacturers, providing healthcare professionals at 2160 W State Road 434 with tailored solutions for specific clinical needs. All processes are conducted within a controlled ISO-classified cleanroom environment by highly trained personnel to guarantee sterility and potency.
503B Compounding Pharmacy is dedicated to supporting the local medical community at its Longwood facility. The team works closely with healthcare providers to understand their practice requirements and offers a portfolio of sterile compounded products designed for office-based procedures and treatments. The assurance of FDA-registered quality provides peace of mind to practitioners, knowing the medications they use adhere to the most exacting standards. For more information or to discuss your practice's needs, please contact 503B Compounding Pharmacy directly.
Website: Phone: (407)993-1381 Location: 2160 W State Road 434, Longwood, FL 32779
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility? It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal regulations, including current Good Manufacturing Practices (cGMP). This ensures a higher level of oversight and quality control for the sterile compounded preparations we produce compared to a traditional pharmacy.
2. As a patient, can I walk into the facility at 2160 W State Road 434 to get a prescription filled? No. 503B Compounding Pharmacy operates as a bulk manufacturer for office use by healthcare providers. We do not dispense medications directly to patients. Your healthcare provider will order and administer our compounded preparations from their office located near our facility in Longwood.
3. What types of medications does 503B Compounding Pharmacy produce? We specialize in producing sterile injectable preparations in bulk quantities. This includes medications that are on national drug shortage lists or are not commercially available from large-scale manufacturers. These preparations are supplied to local clinics, hospitals, and physician offices for use in treatments and procedures.
4. How does a healthcare provider at 2160 W State Road 434 order from your facility? Healthcare providers and their authorized staff can contact our facility directly by phone at (407)993-1381 to establish an account, discuss their specific needs, and place orders. We work directly with medical practices to supply the compounded sterile preparations required for their patients.
5. Why would a healthcare provider choose a 503B outsourcing facility over other suppliers? Healthcare providers choose 503B Compounding Pharmacy for the assurance of FDA-registered quality and compliance. Our status guarantees that our processes and products meet rigorous federal standards for sterility, potency, and purity, which is critical for patient safety and effective treatment outcomes at their practice.