Imprimis Pharmaceuticals announced that it has filed for registration of its recently-constructed New Jersey facility with the FDA as a 503B outsourcing facility. The facility is expected to begin manufacturing as an outsourcing facility in December 2016 and dispensing medications in early first quarter 2017, according to a company news release.
The outsourcing facility will initially make and distribute Imprimis’ proprietary sterile Dropless Therapy injectable and LessDrops topical formulations in accordance with current good manufacturing practices (cGMP). Imprimis designed the facility for the production of its core ophthalmology formulations, outfitting it with automated filling, labeling, and other state-of-the-art equipment that should allow for improved production efficiencies. The ease of customer ordering for office use and stocking inventory should also increase administration and dispensing efficiencies. The company also believes ophthalmologists, surgery centers and other health care providers will benefit greatly by having the ability to simply order the quantities of Dropless Therapy and LessDrops formulations they require for inventory and office use without having to provide patient specific prescriptions.
“This is an important milestone for our company. We believe transitioning the production of our proprietary Dropless Therapy injectable and LessDrops formulations to an outsourcing facility environment should create additional 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," Mark L. Baum, CEO of Imprimis, said in the news release. "Based on our internal research and an April 2015 third party market research report, we expect that adoption of our core ophthalmology formulations will increase as a result of moving to an outsourcing facility environment, once customers are no longer required to provide patient-specific prescriptions. This is an exciting time for Imprimis and I am confident that with the investments in infrastructure, improvements in operating efficiencies and strengthening of our senior leadership team, we are well positioned to meet our existing and anticipated increase in demand for our innovative ophthalmic formulations.”
The DQSA was signed into law on November 27, 2013 and, as enacted, clarifies and strengthens the regulatory framework governing compounding pharmacies. The law’s addition of Section 503B to the Federal Food, Drug and Cosmetic (FD&C) Act established a highly regulated form of entity, an outsourcing facility, that requires both the facility and the products it compounds to be registered with, and regularly inspected by, the FDA.
Other than drugs compounded at a registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.