October has arrived, along with a government shutdown and the ongoing debate over the Patient Protection and Affordable Care Act. Yet just before we turned the page on our calendars, the U.S. House of Representatives passed H.R. 3204, Drug Quality and Security Act (DQSA), a bicameral compounding and track-and-trace bill that now awaits action in the U.S. Senate.
According to Dirk Rodgers, author of RxTrace and Healthcare Packaging Contributing Editor, progress was made during the August recess when managers from separate House and Senate bills and their staffs were able to create a compromise bill. Over this past weekend, the House passed the new bill (see the draft of the bill here).
Rodgers believes the bicameral bill has a good chance to pass in the Senate, an action that could occur at any time. If it does pass, it moves forward for the President’s signature. Presidential approval would mean that the new law would become effective immediately, with serialization requirements taking place four years later. Other provisions would occur at other effective dates, based on when the President signs. The bill’s passage would preempt pending California e-pedigree legislation and give the packaging community between two to three years of additional time to comply compared to the initial Jan. 1, 2015 California e-pedigree phase-in date.
