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Lee Rosebush Comments on FDA Approval for Compounding Outsourcing Facilities to Publish Shortage Drugs They Produce

News / April 29, 2020

Partner Lee Rosebush, who serves as the Chairman and General Counsel for the Outsourcing Facilities Association (OFA), is quoted in an April 29, 2020, news release announcing that the U.S. Food and Drug Administration (FDA) has granted it unprecedented approval, due to the COVID-19 pandemic, to publish a list of compounded drugs that 503B outsourcing facilities prepare than can be used in place of medications that are commercially unavailable or in short supply during the crisis. Many of the medications in short supply are anesthetics used in conjunction with ventilators.

Rosebush said, “This move recognizes the important roles that outsourcing facilities can play during a drug shortage caused by a national emergency. It is our hope that outsourcers can continue to publicly share details about any FDA-recognized drug shortage products. Our members and other 503Bs can produce these medications and are ready to help now and beyond the pandemic.”

Read the article.