Lee Rosebush Decries FDA Insistence that Compounders Use Agency-Approved Substances Rather than Bulk Products

News / April 30, 2018

Partner Lee Rosebush is quoted in an article published April 27, 2018, in Bloomberg’s Health Care Blog. The article, “Bulk Drug Compounders Confounded by FDA Plan,” reports on the Food and Drug Administration (FDA) draft guidance that indicates large-scale drug compounders should use agency-approved substances instead of bulk substances whenever possible.

Rosebush, who is the chairman of the Outsourcing Facilities Association, told the publication, “[T]his guidance document appears to be a direct giveaway to drug manufacturers, as 503Bs would now be required to start with higher-priced products while meeting cGMP standards. This is simply a way for pharma to continue to protect their products and FDA to continue to collect user fees.”