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 is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies adherence to the highest level of federal regulatory standards, which are more rigorous than those applied to traditional 503A compounding pharmacies. This ensures that every preparation leaving the facility meets strict guidelines for potency, sterility, and purity. The core mission of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, reliable medications that are essential for patient care.
The operations at 2160 W State Road 434 are conducted within a controlled environment that complies with Current Good Manufacturing Practices (cGMP). This involves stringent environmental monitoring, validated sterilization processes, and extensive testing of both components and finished preparations. By operating on a larger scale than a traditional pharmacy, 503B Compounding Pharmacy can efficiently produce batches of medications for office use, allowing physicians and clinics to have essential drugs on hand for immediate patient needs. This model supports the local medical community by providing a dependable source for medications that may be in short supply, discontinued, or not otherwise commercially available.
503B Compounding Pharmacy serves an important role for healthcare practitioners. The medications compounded at the Longwood facility are distributed to hospitals, clinics, and healthcare offices for administration to patients under their care. This is distinct from a retail pharmacy that dispenses directly to individual patients. The focus is on producing preparations for office use, ensuring that healthcare providers at 2160 W State Road 434 have the necessary tools to treat their patients effectively and without delay. The facility's commitment to quality and compliance provides practitioners with confidence in the medications they use.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a reliable resource. The dedicated team utilizes advanced technology and rigorous protocols to ensure every product meets its exacting specifications. For more information, please visit or contact the facility directly at (407)993-1381.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 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 standards outlined in Section 503B of the FD&C Act. This includes adhering to Current Good Manufacturing Practices (cGMP) for consistent quality control, testing, and reporting.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility on W State Road 434 are distributed to healthcare providers and facilities for office use. This includes hospitals, clinics, and physician practices. We do not dispense medications directly to individual patients at our location.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications in larger batches. This often includes preparations that are on drug shortage lists, have been discontinued by manufacturers, or are needed for office-based procedures by practitioners in Longwood.
How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434 is comprehensive. It involves rigorous testing of raw materials, in-process testing during compounding, and final product testing for sterility, potency, and endotoxins. Our cGMP compliance ensures these processes are meticulously documented and validated.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate orders or make inquiries by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, available medications, and delivery logistics for the Longwood location.