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Imprimis Pharmaceuticals Registers its Texas Facility with the FDA as an Outsourcing Facility

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Mark L. Baum, CEO of Imprimis, stated, "This is an important milestone for our growing company. We believe transitioning our Dropless Therapy® injectable formulations to an outsourcing facility environment is good for our number one constituent – our patients. And if it is good for our patients, it is good for Imprimis and its shareholders. Importantly, operating as a 503B outsourcing facility should create new revenue opportunities by simplifying the ordering process with existing and new potential customers, including hospitals, group purchasing organizations, and surgery centers, that desire, or in some cases, require purchasing from an FDA-registered outsourcing facility. According to internal research and an April 2015 third party market research report, adoption of our core ophthalmology formulations is expected to increase as a result of moving to an outsourcing facility and once customers are no longer required to provide patient-specific prescriptions."
http://imprimispharm...
Additional Relevant Details Imprimis Pharmaceuticals has filed for registration of its ImprimisRx TX pharmacy, located in Allen, Texas, with the U.S. Food and Drug Administration (FDA) as a 503B outsourcing facility. The Drug Quality and Security Act (DQSA), signed into law on November 27, 2013, created this pathway in which a compounding pharmacy can voluntarily register with the FDA as an outsourcing facility under Section 503B of the federal Food, Drug and Cosmetic Act, comply with the DQSA and avail itself of the operational benefits the law provides.
http://imprimispharm...
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Catalyst Date
Occurred on:
Apr 12, 2016
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