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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility provides large-scale compounding of sterile and non-sterile medications for healthcare providers. The 503B outsourcing facility designation signifies a commitment to a higher standard of quality control and regulatory oversight, ensuring that practitioners at 2160 W State Road 434, Longwood, FL 32779 receive medications that are consistently produced in a controlled environment.
The core function of 503B Compounding Pharmacy is the preparation of medications that are not commercially available or are in shortage. This is achieved through rigorous compounding processes conducted on the premises of 2160 W State Road 434, Longwood, FL 32779. The facility specializes in producing batches of medications for office use by healthcare providers, enabling them to have essential treatments readily available for their patients. The operations at this specific location are dedicated to supporting the local medical community with a reliable source of high-quality compounded pharmaceuticals.
As an FDA-registered outsourcing facility, 503B Compounding Pharmacy adheres to Current Good Manufacturing Practices (cGMP). This ensures that every medication compounded at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for purity, potency, and safety. The facility's compliance with federal regulations provides an additional layer of assurance for healthcare providers utilizing its services. The focus remains exclusively on the professional compounding services provided from this facility to other medical professionals.
503B Compounding Pharmacy provides its specialized services to healthcare providers from its location at 2160 W State Road 434, Longwood, FL 32779. For comprehensive information regarding its capabilities and regulatory status, please visit the official website at https://503bcompoundingpharmacy.com/. To speak directly with a representative regarding services at this facility, you may contact 503B Compounding Pharmacy by phone at (407)993-1381.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the FD&C Act, adhering to Current Good Manufacturing Practices (cGMP) and undergoing federal oversight to ensure the quality and safety of its compounded medications.
What types of medications does 503B Compounding Pharmacy provide?
503B Compounding Pharmacy provides compounded medications, often including those that are commercially unavailable or in shortage, for office use by healthcare providers. These medications are prepared in batches at the facility located at 2160 W State Road 434, Longwood, FL 32779.
Who can order from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides its services to healthcare providers and medical practices. The medications compounded at this location are intended for office use by licensed practitioners.
How does the 503B outsourcing model benefit healthcare providers?
The 503B model provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, consistently compounded medications that meet federal cGMP standards, ensuring reliability and patient safety for in-office treatments.
How can I contact 503B Compounding Pharmacy?
503B Compounding Pharmacy can be contacted via its website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381. The facility is located at 2160 W State Road 434, Longwood, FL 32779.