U.S. House passes track-and-trace bill

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.

Healthcare Distribution Management Assn. (HDMA) President and CEO John M. Gray released the following statement on the passage of H.R. 3204:

“Now that the House of Representatives’ has passed legislation to strengthen the security of the pharmaceutical supply chain only the Senate’s imminent vote stands in the way of establishing a federal uniform traceability framework for prescription medicines. For nearly a decade, HDMA has worked to replace the 50-state patchwork of rules and regulations with a federal solution that ensures regulatory clarity and consistency, helps prevent counterfeits, discourages gray market activities, and enhances the safety and security of the pharmaceutical supply chain for all Americans.

“HDMA thanks Energy and Commerce Committee Chairman Upton, Ranking Member Waxman, and Reps. Dingell, Latta and Matheson for their leadership as this legislation was developed and ultimately passed by the House. We look forward to the final step in the legislative process as we await the Senate vote in the coming days.”

HDMA is a national association representing primary healthcare distributors, the link between pharmaceutical manufacturers and healthcare providers.