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. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality control, sterility, and safety that exceed those of traditional compounding pharmacies. The primary function of this facility is the large-scale compounding of medications for office use, which are then distributed to healthcare providers for administration to their patients within clinical settings.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for healthcare practitioners. This 503B Compounding Pharmacy prepares sterile injectable medications, including IV bags, syringes, and other parenteral preparations, in bulk quantities. These medications are essential for hospitals, clinics, surgical centers, and other healthcare practices, ensuring they have access to critical drugs that may be in short supply or not commercially available. The operations at this location are focused on non-patient-specific, office-use compounding, which is distinct from patient-specific prescriptions.
Quality and compliance are the cornerstones of the operation at 2160 W State Road 434, Longwood, FL 32779. The facility follows current Good Manufacturing Practices (cGMP), which mandate strict environmental controls, extensive testing of components and finished products, and robust standard operating procedures. Every batch of medication compounded at this 503B Compounding Pharmacy undergoes thorough testing to ensure potency, purity, and sterility before it is released for distribution to healthcare providers.
Healthcare providers who source their office-use medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from a reliable supply of high-quality compounded preparations. This facility plays a vital role in the local healthcare ecosystem by mitigating drug shortages and providing essential medications that are necessary for patient care in a variety of medical specialties. The dedicated team at this location is committed to upholding the highest standards of pharmaceutical compounding as defined by its 503B outsourcing facility designation.
For more information about the services available from this specific facility, you can visit the website at or contact the pharmacy directly by phone at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile, non-patient-specific medications for office use by healthcare practitioners, adhering to strict federal quality and safety standards.
2. Can I, as an individual patient, get a prescription filled at this location?
No. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds medications exclusively for office use by healthcare providers. Individual patients should contact a traditional compounding pharmacy for their prescription needs.
3. What types of medications does this 503B facility compound?
This location specializes in compounding sterile injectable medications, such as IV solutions, epidurals, and pre-filled syringes, which are supplied in bulk to hospitals, clinics, and surgical centers for administration to patients within those settings.
4. How does this pharmacy ensure the quality of its compounded preparations?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under current Good Manufacturing Practices (cGMP), which includes rigorous environmental monitoring, validated processes, and extensive testing of all finished products for sterility, potency, and purity.
5. How can a healthcare practice order medications from this facility?
Healthcare practices interested in ordering office-use medications can contact the 503B Compounding Pharmacy directly at (407)993-1381 or through their website at to discuss their specific needs and establish an account.