On Wednesday, a bipartisan group of lawmakers in the House and Senate announced an agreement on legislation that would give FDA greater authority to regulate compounding pharmacies and implement an electronic system to track compounded prescription drugs thoughout the distribution chain, Reuters reports (Clarke, Reuters, 9/25).
Background on Legislation
In April, a bipartisan group of legislators released a draft bill on the issue. The draft bill was crafted by Sens.:
- Lamar Alexander (R-Tenn.);
- Michael Bennet (D-Colo.);
- Richard Burr (R-N.C.); and
- Tom Harkin (D-Iowa).
The lawmakers in a statement said that the draft bill aims to replace a "patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit-level product tracing for the entire country" (iHealthBeat, 4/22).
Details of New Legislation
The new bill -- called the Drug Quality and Security Act -- would allow federal regulators to:
- Track drugs that compounding pharmacies are making;
- Receive reports about problems with the compounded drugs; and
- Have authority to conduct safety inspections.
It also would allow compounding pharmacies to register as outsourcing facilities and be subject to FDA oversight in a manner similar to traditional drug manufacturers (LeBlanc, AP/Atlanta Journal-Constitution, 9/25).
Comments From Lawmakers
Henry Waxman -- ranking member of the House Energy and Commerce Committee -- said, "This legislation is a major stride toward the goal of ensuring the quality and safety of the medicines Americans rely upon every day" (Viebeck, "Healthwatch," The Hill, 9/25).
In addition, Harkin -- chair of the Senate Health, Education, Labor and Pensions Committee -- praised the creation of "an unprecedented tracing system that will track prescription drugs from manufacturing to distribution" (Senate HELP Committee release, 9/25).