Lawmakers Push Bicameral Bill to Trace Prescription Manufacture
The House-passed Drug Quality and Security Act would prevent disease outbreaks by ensuring all drugs sold in the U.S. are manufactured with Food and Drug Administration consent, said Congresswoman Marsha Blackburn, R-Tenn., following the Sept. 28 passage (here) of the legislation. The Senate sister bill (here) may be taken up in the Senate in the coming days, said a HELP press official. The Drug Quality and Security Act would not have to go through conference because of the bicameral support, said the HELP official.
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The bill would implement a tracing system, enabling scrutiny over the entire manufacturing to distribution process, said HELP Chairman Tom Harkin, D-Iowa. Ranking member Lamar Alexander, R-Tenn., Senator Al Franken, D-Minn., Senator Pat Roberts, R-Kan., Senator Michael Bennet, D-Colo., and Senator Richard Burr, R-N.C., the other senators involved in crafting the legislation, said the legislation would curb disease outbreak and counterfeiting. According to the Senators, the bill would:
- Strengthen license requirements for wholesale distributors and third-party logistics providers.
- Develop a workable pathway to unit-level tracing in a decade.
- Establish nationwide drug serial numbers.
- Distinguish compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions.
- Define FDA’s role in oversight of outsourcing facilities.
- Offer providers and patients better information about compounded drugs.
- Clarify current federal law regarding pharmacy compounding.