Imprimis Pharmaceuticals, Inc., announced that it has commenced construction on the company’s Allen, Texas compounding pharmacy and plans to register the pharmacy with the 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, Texas facility commences 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.
Mark L. Baum, CEO of Imprimis stated, “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. Fortunately, our Allen, Texas 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. We have begun renovations and purchased the equipment required for our Allen, Texas pharmacy to serve as an outsourcing facility at a cost of less than $200,000.
“We plan to initially use this location for our HLA compounded formulation prescribed for interstitial cystitis (IC) and later expand to include our ophthalmology Dropless TherapyT injectable and LessDropsT 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.
“Our new Allen, Texas facility will also be helpful to our ophthalmology customers. Once it begins operations as an outsourcing facility, physicians, ambulatory surgical centers and hospital customers, and their patients, will appreciate the convenience of having the ability to order an inventory of our proprietary compounded formulations for immediate office use.”
The company intends to open and qualify its larger, state of the art Roxbury, New Jersey outsourcing facility during the first quarter of 2016.
Currently, all Imprimis formulations may be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.
