Draft legislation would establish uniform, electronic drug tracking system

A bipartisan draft bill would create a uniform, national traceability system that tracks drugs from their manufacturing source through their final destination on drugstore shelves.

The discussion draft, released by Sens. Lamar Alexander (R-Tenn.), Michael Bennet (D-Colo.), Richard Burr (R-N.C.) and Tom Harkin (D-Iowa) of the Senate Health, Education, Labor and Pensions Committee, would amend the federal Food, Drug and Cosmetic Act to replace state product tracing laws with a nationwide electronic, interoperable unit level product tracing system.

Under the bill, every entity in the drug supply chain—including manufacturers, repackagers, wholesale distributors, third-party logistic providers and dispensers—would be required to input transaction information and ownership change information. No player in the chain could accept drugs lacking sufficient transaction information.

Licensing requirements for wholesale distributors and third-party logistic providers also are tightened in the bill. The FDA likewise would manage a publicly available online database of wholesale distributors. “This empowers both consumers and members of the pharmaceutical distribution supply chain to identify appropriately licensed wholesalers,” according to the senators’ April 22 statement on the draft.

"Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drugstore shelves,” Sen. Bennet said in the statement. “In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death. This draft bill would put steps in place to prevent and reduce those problems and help ensure our drug supply is safe.”

The senators are seeking comment on the draft until April 26.