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 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 traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving the facility meets stringent quality control standards for potency, purity, and sterility.
The core service of 503B Compounding Pharmacy is the large-scale compounding of medications that are not available commercially. The team at the Longwood facility specializes in producing sterile injectables, ophthalmic preparations, and other complex dosage forms in bulk for healthcare facilities. By operating from 2160 W State Road 434, 503B Compounding Pharmacy provides a critical service, ensuring that local practitioners have access to essential medications that are often in short supply or discontinued by major manufacturers. The pharmacy’s work supports patient care by enabling physicians to obtain the specific medications required for their treatment protocols.
Patients and healthcare providers who engage with 503B Compounding Pharmacy at 2160 W State Road 434 benefit from a process designed for reliability and safety. The facility’s adherence to cGMP means that every batch of medication is produced in a controlled environment with extensive documentation and testing. This level of quality assurance is a fundamental aspect of the 503B outsourcing model. For any inquiries regarding services or to initiate an order, 503B Compounding Pharmacy can be contacted directly at (407)993-1381. Further information about the facility’s capabilities and compliance is available on the official website at https://503bcompoundingpharmacy.com/.
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 sterility, potency, and quality.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily provides compounded medications to healthcare facilities and practitioners for office use. Patients receive these medications directly from their healthcare provider at the point of care. Individual patient-specific prescriptions are not the primary focus of the 503B outsourcing facility model.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in compounding sterile preparations, including injectables, IV bags, and ophthalmic solutions. These are often medications that are on shortage or unavailable from conventional manufacturers, providing a vital supply for local medical practices.
How does the quality control process work at your facility?
As a 503B outsourcing facility, we implement rigorous quality control measures mandated by cGMP. This includes environmental monitoring, validation of sterilization processes, and testing of raw materials and finished products for potency, sterility, and endotoxins to ensure every batch is safe for patient use.
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. Our team will guide them through the process. More details about our services can also be found on our website at https://503bcompoundingpharmacy.com/.