Compounding, track-and-trace bill likely to become law

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Senate votes to advance H.R. 3204; FDA supports the bill

Final passage of the compounding and track-and-trace legislation is expected early next week. On November 12, the Senate voted 97–1 to advance the Drug Quality and Security Act (H.R. 3204) on a cloture motion—a procedure by which the Senate can vote to place a time limit on consideration of a bill to overcome a filibuster.

Debate in the Senate has been stalled for a couple of days. The bill has already passed the House by voice vote. APhA supports H.R. 3204.

“There will be no differences between what passes out of each chamber and the president will not veto the bill,” explained APhA Senior Lobbyist Michael Spira.

When debate began in the Senate on Tuesday afternoon, Sen. Tom Harkin (D-IA), Chair of the Health, Education, Labor, & Pensions Committee, specifically recognized and thanked four or five groups, including APhA, for supporting the legislation in his remarks on the Senate floor, according to Spira.

“APhA has been heavily involved in the drafting of this legislation through dozens and dozens of meetings, phone calls, and e-mails,” wrote APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, in a blog post Tuesday evening.

In related news, APhA government affairs staff attended a Bloomberg Government conference on November 5. The keynote speaker, FDA Commissioner Margaret A. Hamburg, MD, touched briefly on the compounding bill to say that FDA supported the bill, according to Michael Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.

FDA Commissioner Margaret A. Hamburg, MD, with APhA Associate Director of Health Policy Michael Ghobrial, PharmD, JD

Hamburg said that H.R. 3204 is not as comprehensive as FDA would have hoped but that the measure will help. She noted that FDA is concerned with the current regulatory oversight of compounding pharmacies, but clarified that the concern is with very large volume drug compounders shipping high-risk products, such as sterile injectables, across state lines—not with compounding in traditional “mom and pop” pharmacies.

Hamburg ended her comments by highlighting the value of large volume drug compounders to hospitals, clinics, and patients.

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