San Diego-based Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) – a national leader in the development, production and dispensing of novel compounded pharmaceuticals announced that it plans to register its Texas Pharmacy with the FDA as an Outsourcing Facility.
The new planned outsourcing facility is expected to comply with the Current Good Manufacturing Practices (cGMP) and register with the FDA under 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). Increased customer convenience is expected as a result of physicians no longer having to complete patient-specific prescriptions for certain of Imprimis’ key proprietary compounded formulations
When the facility starts its operations as an outsourcing facility in Allen Texaa, physicians, hospitals and ambulatory surgical centers will have the opportunity to prescribe and receive some of Imprimis’ proprietary compounded formulations with greater ease and without the time delays associated with the current requirement of providing patient-specific prescriptions and related shipping times.
Imprimis’ Texas facility hopes to be completed and dispensing certain prescriptions as an outsourcing facility on or before February 1, 2016. In the meantime, the pharmacy will continue its current operations without disruption of service during construction.
The company believes this is the future for sterile compounding pharmacies. They have been advocates of the new law and increased FDA oversight to ensure public confidence in quality and patient safety. They have begun renovations and purchased the equipment required for their Allen, Texas pharmacy to serve as an outsourcing facility at a cost of less than $200,000. The initial plan is to use this location for their HLA compounded formulation prescribed for interstitial cystitis (IC) and later expand to include ophthalmology Dropless Therapy™ injectable and LessDrops™ combination topical eye drop compounded formulations. IC is emergent in nature and patients don’t have the luxury of waiting for their medication to be prescribed, dispensed and arrive days later. The disease process and patient experience for this condition mandates that the patient have immediate access to this medication when prescribed. The Allen, Texas facility will also be helpful to ophthalmology customers. Once it begins operations as an outsourcing facility, physicians, ambulatory surgical centers and hospital customers, and their patients, should benefit from the convenience of having the ability to order an inventory of their proprietary compounded formulations for immediate office use.
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