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 establishes a critical distinction, setting this facility apart from traditional compounding pharmacies. The 503B outsourcing facility is subject to rigorous current good manufacturing practice (cGMP) standards and undergoes regular FDA inspections. This ensures that every preparation leaving the facility meets the highest possible standards of quality, purity, and potency for the patients and healthcare providers it serves at its Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications in anticipation of receiving prescriptions. This proactive manufacturing model allows the facility to supply healthcare facilities, such as hospitals, clinics, and physician offices, with essential medications that may be in short supply or discontinued by commercial manufacturers. By providing a reliable source of high-quality compounded preparations, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, plays a vital role in supporting the local healthcare infrastructure and ensuring patient care continues without interruption.
Patients and medical professionals visiting or utilizing the services of 503B Compounding Pharmacy can be assured of a commitment to uncompromising quality. The facility's operations are designed to mitigate risk and enhance patient safety through a controlled environment, validated processes, and stringent testing protocols. This focus on regulatory compliance and excellence is the foundation of the trust placed in this 503B outsourcing facility by the local medical community at its specific location on W State Road 434.
For more information on the services provided, you can visit the facility's website at or contact them directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy is dedicated to fulfilling the needs of the healthcare providers and patients who rely on its specialized compounding services in Longwood.
FAQ
What does it mean that this is a 503B compounding pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile and non-sterile medications without receiving patient-specific prescriptions first. It operates under stricter federal regulations, including cGMP standards, and is subject to routine FDA inspections to ensure the highest level of quality and safety for its preparations at 2160 W State Road 434, Longwood, FL 32779.
Can I as an individual patient get a prescription compounded here?
503B Compounding Pharmacy primarily supplies its preparations to healthcare facilities. Individual patients typically receive medications that have been dispensed by a clinic, hospital, or physician's office that sources from this outsourcing facility. For personal prescriptions, you would need to consult with your healthcare provider about the dispensing process.
What kinds of medications does this 503B outsourcing facility compound?
The 503B compounding pharmacy focuses on compounding preparations that are often on drug shortage lists or have been discontinued by large-scale manufacturers. This includes a wide range of sterile injectables, IV preparations, ophthalmics, and other essential medications needed by healthcare providers serving patients in the area.
How does the quality assurance at a 503B differ from a regular pharmacy?
As an FDA-registered outsourcing facility, this 503B compounding pharmacy adheres to current good manufacturing practices (cGMP), which are the same standards followed by major pharmaceutical manufacturers. This involves extensive environmental monitoring, rigorous testing of components and finished preparations, validated sterilization processes, and comprehensive standard operating procedures that far exceed the standards for a traditional pharmacy.
How can a local healthcare facility order from this 503B compounding pharmacy?
Healthcare facilities and providers interested in sourcing medications can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their specific needs, establish an account, and learn about the ordering process and available preparations compounded at the Longwood location.