Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779. This designation, granted under Section 503B of the Federal Food, Drug, and Cosmetic Act, defines the specific operational and quality standards adhered to at this location. The 503B Compounding Pharmacy provides bulk compounded medications for office use by healthcare practitioners, distinguishing its services from traditional retail pharmacy models.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded preparations. These medications are prepared in advance of receiving a patient-specific prescription and are intended for distribution to healthcare providers for office use. The facility at 2160 W State Road 434, Longwood, FL 32779 is structured to meet the rigorous FDA standards required for an outsourcing facility, which include current good manufacturing practices (cGMP), stringent quality control protocols, and detailed reporting of adverse events.
Healthcare professionals in Longwood who utilize the services of 503B Compounding Pharmacy benefit from access to a reliable supply of high-quality compounded medications. The portfolio typically includes a range of preparations that may be in short supply or not available from conventional pharmaceutical manufacturers. By sourcing from this local 503B outsourcing facility, practitioners can ensure they have necessary medications on hand for immediate administration to patients during office visits, enhancing treatment efficiency and patient care.
The operational integrity of 503B Compounding Pharmacy is central to its service offering. The processes employed at the 2160 W State Road 434 location are designed to ensure every preparation meets exacting standards for potency, purity, and sterility. This commitment to quality and compliance provides healthcare providers with confidence in the medications they obtain from this FDA-registered outsourcing facility. For more information or to inquire about services, contact 503B Compounding Pharmacy directly at (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility? It means this specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with federal standards for compounding medications in bulk for office use by healthcare practitioners, including adherence to current good manufacturing practices (cGMP).
Who can receive medications directly from 503B Compounding Pharmacy? 503B Compounding Pharmacy distributes compounded medications to healthcare practitioners for office use. Patients do not receive medications directly from this facility; instead, their healthcare provider administers or dispenses the medication from their office stock obtained from the outsourcing facility.
What types of medications does 503B Compounding Pharmacy prepare? As an outsourcing facility operating under Section 503B, 503B Compounding Pharmacy prepares bulk quantities of both sterile and non-sterile compounded medications that are often used by healthcare providers in a clinical setting, which may include medications that are on shortage or not commercially available.
How does a healthcare provider at 2160 W State Road 434 order from 503B Compounding Pharmacy? Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 to establish an account and discuss their specific needs. Orders are placed by the provider or their authorized staff for pickup or delivery to their practice location.
Why would a healthcare provider choose 503B Compounding Pharmacy over a traditional compounding pharmacy? A healthcare provider may choose this FDA-registered outsourcing facility because it operates under federal oversight and cGMP standards, which provide an additional layer of quality assurance for non-patient-specific compounded medications used in their practice at 2160 W State Road 434, Longwood, FL 32779.