On November 27, President Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA), into law. The Act gives FDA the authority to regulate specialty compounding drugs and creates a voluntary program for FDA to regulate companies that manufacture batch compounded drugs that elect to register with FDA. DQSA also establishes a national track-and-trace system to secure the pharmaceutical supply chain and minimize opportunities for contamination, adulteration, diversion, or counterfeiting. The Act is in response to a 2012 meningitis outbreak, which was traced back to products manufactured by the New England Compounding Center.
House Energy and Commerce Committee Chairman Fred Upton (R-MI) applauded the president’s signing of the Act. “With the president’s signature, this bipartisan law will help prevent future crises like last year’s deadly fungal meningitis outbreak while also establishing a unified framework for maintaining safety throughout the drug supply chain. Across the nation, Americans going to their doctor’s office or pharmacy will now have the confidence that their drugs are safe,” said Chairman Upton in a press release. “From bipartisan oversight to drafting and approving legislation, we were able to reach a compromise to protect the drug supply and also remove regulatory roadblocks, creating an environment conducive to job creation. I am thankful for the cooperation of my colleagues in both the House and the Senate, on both sides of the aisle, for their efforts in this achievement.”
FDA released three draft guidance documents on Dec. 2, 2013 as a result of DQSA. One guidance, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act, explains FDA’s enforcement actions. The other two, Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, outline the new voluntary registration program.
For more on this topic, see Provider Demand to Drive Compounder Registration with FDA.