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 facility is located at 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility designation signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. This location adheres to rigorous Current Good Manufacturing Practices (cGMP) as mandated by the FDA, ensuring that every preparation meets stringent quality control standards before it is dispensed.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. This facility prepares medications for office use, which are then distributed to healthcare providers and practitioners for administration to their patients within their practice settings. The services provided at 2160 W State Road 434, Longwood, FL 32779 are essential for supporting the local medical community by supplying medications that are not commercially available or are in shortage. This includes a wide range of preparations such as injectables, ophthalmics, and other dosage forms required by physicians, surgeons, and clinics.
By operating as a 503B outsourcing facility, this pharmacy provides a critical service that is distinct from traditional retail compounding. The focus is on non-patient-specific, office-use medications that are vital for procedures, treatments, and therapies administered by healthcare professionals. The team at 2160 W State Road 434, Longwood, FL 32779 consists of skilled pharmacists and technicians who utilize advanced technology and sterile techniques to compound medications with precision and accuracy. The facility's operations are designed to support the specific needs of the healthcare providers it serves from its location at 2160 W State Road 434, Longwood, FL 32779.
For more information about the services provided, you can visit the website at or contact the facility directly by phone at (407)993-1381. 503B Compounding Pharmacy is dedicated to its role as a reliable source of high-quality compounded medications for office use from its facility in Longwood.
Frequently Asked Questions
What does it mean to be a 503B outsourcing facility?
Being a 503B outsourcing facility means this pharmacy is registered with the FDA and operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. The facility at 2160 W State Road 434, Longwood, FL 32779 complies with stricter cGMP standards for the large-scale compounding of medications intended for office use by healthcare practitioners.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are dispensed for office use to healthcare providers and practitioners. These are non-patient-specific medications that are administered to patients within a clinical setting, not directly to individual members of the public.
What types of medications are compounded at this location?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectables, ophthalmics, and other non-sterile preparations that are often on shortage or unavailable from commercial manufacturers, specifically for use by local healthcare providers.
How does this facility ensure medication quality and safety?
The facility at 2160 W State Road 434, Longwood, FL 32779 adheres to Current Good Manufacturing Practices (cGMP). This involves rigorous testing, environmental monitoring, validation of processes, and quality control measures to ensure every compounded preparation meets exacting standards for potency, purity, and sterility.
How can a healthcare provider place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly at (407)993-1381. The team will provide information on ordering protocols for medications compounded at 2160 W State Road 434, Longwood, FL 32779.