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 is an FDA-registered outsourcing facility operating 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 and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality, safety, and production, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for patient-specific medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of compounded medications in advance of or without receiving a patient-specific prescription. distributed to hospitals, clinics, and physician practices for office use. The operations at 2160 W State Road 434, Longwood, FL 32779 are strictly controlled under current Good Manufacturing Practices (cGMP), ensuring every preparation meets exacting specifications for potency, purity, and sterility. This is a distinct advantage for medical professionals seeking a trusted supplier for their practice's needs.
Services provided by 503B Compounding Pharmacy at its location on 2160 W State Road 434, Longwood, FL 32779 include the compounding of sterile injectables, ophthalmics, and other dosage forms that require an aseptic environment. The facility is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians who are experts in sterile compounding techniques. This ensures that all medications produced are of the highest quality and free from contaminants, providing a critical service for healthcare delivery from the facility at 2160 W State Road 434, Longwood, FL 32779.
503B Compounding Pharmacy provides healthcare practitioners with essential medications that may be in short supply or discontinued by major manufacturers. By compounding these vital drugs, the pharmacy at 2160 W State Road 434, Longwood, FL 32779 helps to prevent treatment delays and supports continuity of care. The team works diligently to fulfill the needs of the medical community, emphasizing a commitment to safety, compliance, and reliability from their base of operations at 2160 W State Road 434, Longwood, FL 32779.
For more information on the services available from 503B Compounding Pharmacy, you can visit their website at or contact them directly by phone at (407)993-1381. The facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the highest standards of pharmaceutical compounding as defined by its 503B status.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal regulations, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet the highest standards for quality, sterility, and strength.
Who can purchase medications from 503B Compounding Pharmacy at 2160 W State Road 434?
As a 503B outsourcing facility, we provide compounded medications to licensed healthcare practitioners and facilities for office use. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779 without a prescription order from a licensed provider.
What types of medications does 503B Compounding Pharmacy specialize in?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in the large-scale compounding of sterile preparations, including injectables, ophthalmics, and other formulations that require an aseptic processing environment, all produced under cGMP standards.
How does 503B Compounding Pharmacy ensure medication safety?
Our facility at 2160 W State Road 434, Longwood, FL 32779 follows rigorous cGMP protocols. This includes extensive testing of components and finished products, environmental monitoring, validation of processes and equipment, and comprehensive documentation for every batch compounded to ensure safety and quality.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their needs. Our team at 2160 W State Road 434, Longwood, FL 32779 will provide information on ordering and our available medication formulations.