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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the operations at the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality, safety, and production, which are distinct from those of traditional compounding pharmacies. The primary function of this facility is the large-scale, non-patient-specific compounding of sterile and non-sterile medications that are then distributed to healthcare providers and facilities for office use.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are defined by the 503B model. This includes the compounding of injectable medications, ophthalmics, and other sterile preparations in bulk quantities. These medications are essential for hospitals, clinics, surgical centers, and other healthcare providers who require readily available, high-quality medications for procedures and patient care. The 503B Compounding Pharmacy at this location follows current Good Manufacturing Practices (cGMP), ensuring every batch of medication is produced with consistent quality, potency, and purity. This involves stringent environmental controls, validated processes, and extensive testing to ensure the safety and efficacy of all preparations leaving the facility.
Patients and healthcare professionals in the area can be assured that the medications compounded at 2160 W State Road 434, Longwood, FL 32779 meet the highest regulatory standards. The 503B outsourcing facility is subject to regular and unannounced inspections by the FDA, providing an additional layer of oversight and confidence. The team at this location is comprised of skilled pharmacists and technicians who are experts in the science of sterile compounding, dedicated to supporting the local medical community with reliable pharmaceutical products. For more information or to discuss needs, please contact the facility directly.
Website: | Phone: (407)993-1381
Frequently Asked Questions
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, adhering to strict federal manufacturing standards under Section 503B.
Who can receive medications from this 503B facility?
Medications compounded at this location are distributed to healthcare providers and facilities, such as hospitals, clinics, and surgical centers. Patients receive these medications directly from their provider during a procedure or office visit, not from the pharmacy itself.
What types of medications are compounded at this location?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in sterile preparations, including injectables, IV bags, and ophthalmic solutions, which are provided in bulk for healthcare settings.
How does the 503B model ensure medication safety?
This facility operates under current Good Manufacturing Practices (cGMP) and undergoes regular FDA inspections. This ensures consistent quality, sterility, and potency through validated processes, environmental monitoring, and rigorous testing.
How can a healthcare provider place an order with this facility?
Healthcare providers and facilities can contact the 503B Compounding Pharmacy directly at (407)993-1381 to discuss their specific medication needs and the ordering process for office-use compounds.