House Compounding Bill Seeks to Provide Clarity and Balance Between FDA and State Boards of Pharmacy Oversight
Last week, Representatives Morgan Griffith (R-Virginia), Diana DeGette (D-Colorado), and Gene Green (D-Texas) introduced in the House compounding legislation entitled the "Compounding Clarity Act of 2013" (H.R. 3089) that could give FDA additional official authority under the Federal Food, Drug, and Cosmetic Act ("FD&C Act") over compounding facilities. The Bill comes after almost a year after contaminated drugs from a Massachusetts compounding facility caused 64 people to die from fungal meningitis.
According to Green, "For the last several weeks, a bipartisan and bicameral group of lawmakers have been meeting to make sure we never relive the tragedy of the 2012 fungal meningitis outbreak that originated in a compounding pharmacy in Massachusetts." Griffith said that the bill would "prevent another [New England Compounding Center]-type outbreak from occurring and ensuring the quality and safety of all compounded drugs in the country."The Bill would amend Section 503A of the FD&C Act with a new framework and standards for traditional compounding pharmacies and additional FDA oversight for large-scale compounding like the New England Compounding Center. The legislation would help remove the Constitutional concerns concerning advertising that had been raised in various court cases and had raised certain questions about FDA's regulatory authority over compounding.