Legislative Issues

Isotope Availability

In 2012 Congress enacted S. 99, the American Medical Isotopes Production Act of 2011, as part of the Defense Authorization bill.  S. 99 addressed some of the technology and waste disposal issues that were obstacles to the development of new Molybdenum-99 (Mo-99) production facilities.  The U.S. consumes approximately one-half of the world’s supply of Mo-99, but currently has no domestic source of supply.

Compounding

Some nuclear pharmacies compound certain radiopharmaceuticals and adjunct drugs, especially during times of shortages, after discontinuation by the manufacturer not related to safety issues, and for other reasons. On September 28, 2013, the House of Representatives approved a new bill, H.R. 3204, the Drug Quality and Security Act. The Senate also passed H.R. 3204 by voice vote on November 18. President Obama signed the bill on November 27 as Public Law No: 113-54.