H.R. 3204 Drug Quality and Security Act Signed Into Law

Published Online: Wednesday, November 27, 2013
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November 27, 2013 (WASHINGTON, DC) – The American Pharmacists Association (APhA) applauds the final passage of H.R. 3204 the Drug Quality and Security Act. President Obama officially signed the compounding and track-and-trace legislation into law this afternoon during a bill signing ceremony in the Oval Office.

“APhA is grateful to Congress, staffers and the President for their focus on this challenging issue,” stated APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA. “APhA played the critical role of a voice for the individual pharmacist throughout the drafting of this legislation by maintaining active involvement and communication with the HELP committee. Throughout the process we supported protecting patients from harm by improperly manufactured drug products while ensuring patient access to needed and properly prepared compounded medications.”

The legislation distinguishes compounders engaged in traditional pharmacy practice (ie: office use or one product per one patient prescription) from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the Food and Drug Administration as “outsourcing facilities,” subject to FDA oversight in much the same way as traditional manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.

The new law also offers providers and patients better information about compounded drugs, by directing FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requiring detailed labeling on compounded drugs, and prohibiting false and misleading advertising.

“We appreciate that the legislation provides a clear delineation between compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions,” APhA wrote in a letter of support. “Our members were concerned about being forced to register with the FDA and this legislation would allow traditional pharmacies to continue to be regulated by state boards of pharmacy while creating outsourcing facilities that would be subject to FDA oversight.”

The legislation also includes the creation of a track-and-trace pathway for the more than 4 billion prescriptions that are written in America every year, which helps to ensure the safety of the drug-supply chain. The bill creates a new uniform framework for tracking drugs from the manufacturer to the pharmacy, including strengthening licensure requirements for wholesale distributors and third-party logistics providers and establishing nationwide drug serial numbers.
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