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 signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike a traditional 503A pharmacy, this 503B outsourcing facility prepares medications in larger batches for office use, supplying healthcare practitioners with essential drugs that are not commercially available. The operations at this specific location are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring that every preparation meets stringent identity, strength, quality, and purity standards.
The core service of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded medications for office use. Healthcare providers at medical practices, hospitals, and clinics can rely on this facility as a trusted source for critical medications that are often on shortage or discontinued by major manufacturers. By providing these vital preparations, 503B Compounding Pharmacy supports the local medical community, enabling practitioners to obtain necessary treatments for their patients without the burden of in-house compounding. The facility’s work is integral to patient care, ensuring a consistent and reliable supply of high-quality compounded pharmaceuticals.
Patients and healthcare professionals visiting or utilizing the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be assured of a operation dedicated to precision and safety. The facility employs advanced technology and meticulous processes to compound a range of preparations. This includes sterile injectables, ophthalmics, and other dosage forms that are essential for various treatments. The focus remains on serving the specific needs of the medical community by providing bulk compounded drugs that are essential for office-based procedures and patient care protocols.
For more information about 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 supporting the healthcare infrastructure from its location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. It compounds medications in larger batches for office use by healthcare practitioners and is subject to strict FDA oversight and current Good Manufacturing Practice (cGMP) regulations.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Medications are prepared for office use and are distributed to healthcare practitioners and entities, such as hospitals, clinics, and medical practices. The facility provides medications for practitioners to administer to patients within their care.
What types of medications does this 503B facility compound?
The 503B Compounding Pharmacy compounds a range of sterile and non-sterile preparations, including injectables and ophthalmics, that are often on drug shortage lists or are no longer available from commercial manufacturers.
How does the quality assurance at a 503B outsourcing facility differ?
As an FDA-registered 503B outsourcing facility, it must comply with more rigorous cGMP standards compared to a traditional pharmacy. This includes extensive testing of components and finished preparations, environmental monitoring, and adherence to strict standard operating procedures to ensure product quality and safety.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly by phone at (407)993-1381 to discuss their needs and place an order for compounded medications for office use.