Imprimis Pharmaceuticals, a pharmaceutical company focused on the development and commercialization of proprietary and customizable drug formulations, announced that it 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.
The ImprimisRx TX facility will make and distribute compounded drugs according to current good manufacturing practices (cGMP), which are the same standards used for the manufacture of FDA-approved drugs. ImprimisRx TX will initially distribute the company's proprietary sterile Dropless Therapy® injectable formulations, which are administered following ocular surgery, primarily cataract surgery. Once operating as an outsourcing facility, ophthalmologists will have the ability to simply order the quantities they need for inventory and office use, without providing patient specific information that is required today. The company expects to begin distributing from the facility towards the end of the second quarter of this year.
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."
Mr. Baum concluded, "We believe increased adoption of cGMP production standards, the same manufacturing standards that FDA-approved drugs are held to, will ensure public confidence in quality and patient safety for compounded drugs. We have also been engaged in efforts to improve the DQSA so that more compounded drugs are made in a cGMP environment. We fully expect that the FDA will remain a supportive partner as outsourcing facilities continue to operate and build quality-made finished pharmaceuticals under FDA scrutiny. We look forward to being a part of the outsourcing facility community and using the provisions of the DQSA to better serve the many thousands of patients we serve each week."