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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile medications. The 503B designation signifies adherence to stringent federal quality and safety standards, providing a critical service for healthcare providers and patients at this specific location.
The core function of 503B Compounding Pharmacy is the non-patient-specific compounding of medications. This means medications are prepared in larger batches for office use by healthcare practitioners, ensuring immediate availability for patient needs. The facility at 2160 W State Road 434, Longwood, FL 32779, compounds a range of sterile preparations, including injectables, ophthalmics, and other formulations required in clinical settings. All processes are conducted under rigorous environmental controls and quality testing protocols mandated by the FDA.
Healthcare professionals seeking a reliable source for high-quality compounded medications utilize the services of this FDA-registered outsourcing facility. By operating under Section 503B, 503B Compounding Pharmacy provides an essential component of the healthcare supply chain, directly serving the needs of practitioners and their patients from its location at 2160 W State Road 434, Longwood, FL 32779.
For more information, you can visit or contact the facility directly at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779, is registered with the U.S. Food and Drug Administration and compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act, following Current Good Manufacturing Practices (cGMP).
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at this outsourcing facility are typically distributed to healthcare professionals for office use rather than directly to individual patients. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779, can utilize these medications for administration in their practice.
What types of medications does 503B Compounding Pharmacy prepare?
As an FDA-registered outsourcing facility, this location specializes in compounding sterile preparations, such as injectable medications, ophthalmic solutions, and other sterile products required for clinical use.
How does the 503B Compounding Pharmacy ensure medication quality and safety?
The facility at 2160 W State Road 434, Longwood, FL 32779, adheres to strict federal cGMP standards, which include rigorous testing, environmental monitoring, and quality control procedures to ensure the safety, identity, strength, and purity of all compounded preparations.
How can a healthcare professional order from 503B Compounding Pharmacy?
Healthcare professionals can contact 503B Compounding Pharmacy directly at (407)993-1381 to inquire about available medications and the ordering process for the facility at 2160 W State Road 434, Longwood, FL 32779.