Imprimis Registers Texas Site as an Outsourcing Facility

Imprimis Pharmaceuticals Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary compounded drug therapies, started construction on the company’s Allen, TX, compounding pharmacy and plans to register the pharmacy with the U.S. Food and Drug Administration (FDA) as a 503B sterile outsourcing facility under the Drug Quality and Security Act (DQSA) of 2013. The DQSA was signed into law by President Obama on November 27, 2013 and created a new pathway, in which a compounding pharmacy can register with the FDA as an outsourcing facility.

Once the Allen facility begins operations as an outsourcing facility, physicians, hospitals and ambulatory surgical centers will have the opportunity to prescribe and receive certain 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 is expected 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.

“We believe this is the future for sterile compounding pharmacies and we have been advocates of the new law and increased FDA oversight to ensure public confidence in quality and patient safety,” said Mark Baum, chief executive officer, Imprimis. “Fortunately, our Allen, TX facility was a very good candidate for a low cost upgrade to a 503B outsourcing facility given the quality of the existing compounding infrastructure we recently purchased.” 

In addition, the company says it intends to open and qualify its larger, state-of-the-art Roxbury, NJ outsourcing facility during the first quarter of 2016.