The Drug Quality and Security Act (H.R. 3204) is a new name for a new bill addressing both compounding and track and trace on which agreement was reached by leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor, & Pensions (HELP) Committee. Introduced on September 27, the bill passed the House by voice vote on September 28.
House Energy & Commerce and Senate HELP staff had negotiated behind the scenes to reach agreement, according to APhA Senior Lobbyist Michael Spira. The Senate is expected to take up the bill soon.
In the wake of the ongoing fungal meningitis tragedy linked to the New England Compounding Center, Congress is moving quickly now to act on the Drug Quality and Security Act. Older bills include the Compounding Clarity Act (H.R. 3089) introduced September 12 by Reps. Morgan Griffith (R-VA), Gene Greene (D-TX), and Diana DeGette (D-CO); a Senate HELP Committee bill (S. 959); and a bill introduced by former House Democrat Sen. Ed Markey (D-MA) (H.R. 2186).
The Drug Quality and Security Act would help ensure the safety of compounded drugs and would track all prescription drugs from the manufacturer to the pharmacy, according to a September 28 news release from the Senate HELP Committee.
Related to compounding, the proposed legislation would distinguish compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions; would define FDA’s role in oversight of outsourcing facilities; would offer providers and patients information about compounded drugs; and would clarify current federal law regarding pharmacy compounding.
More specifically, traditional pharmacies would continue to be primarily regulated by state boards of pharmacy. But compounders who wish to practice outside the scope of traditional pharmacy practice could register as outsourcing facilities that would be subject to FDA oversight in much the same way as traditional manufacturers. Providers and patients would have the option of purchasing products from outsourcing facilities that comply with FDA quality standards.
Related to track and trace, the proposed legislation would develop a pathway to unit-level tracing in 10 years; would strengthen licensure requirements for wholesale distributors and third-party logistics providers; and would establish nationwide drug serial numbers.
On September 26, when the Drug Quality and Security Act was a draft proposal being circulated to stakeholders for comments, APhA sent a comment letter to HELP Committee staff that (among other suggestions) recommended the legislation include an advisory council that would include pharmacists. In less than a day, the bill was introduced—and altered from the draft proposal version to reflect that particular concern.
“Up to the minute, [Government Affairs staff has] been talking, e-mailing, meeting with Senate and House staff,” Spira said. “Constant communication.”
“We are pleased with the progress made as APhA has been working with both chambers and other stakeholders for months to shape an effective bill that maintains patient access to pharmacist-compounded preparations while protecting the public’s health,” APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPHA, said in a CEO Blog post published September 27. “While we still have concerns with the newly introduced legislation, such as the omission of office use, we are still working with staff to produce a better bill.”
The reactions of other pharmacy groups have varied. The International Academy of Compounding Pharmacists is opposed to the bill. Among the groups supporting the proposed legislation are the American Society of Health-System Pharmacists, National Community Pharmacists Association, and National Association of Chain Drug Stores.