Congress Warns DSCSA Could Disrupt Drug Supply

Starting Nov. 27, all drugs must be able to be tracked electronically on the unit level.

A bipartisan group of 28 members of Congress is urging the US Food and Drug Administration to address drugmakers' concerns that they may not fully comply with the Drug Supply Chain Security Act when it takes effect in late November.  

Under DSCA, starting on Nov. 27, all drugs must be able to be tracked electronically on the unit level. Drugs that do not comply cannot be distributed or dispensed to patients.

In a letter this week to FDA Commissioner Robert M. Califf, MD, the lawmakers expressed support for DSCSA and write that it "will ultimately improve the ability to trace pharmaceutical products and remove potentially dangerous products from the pharmaceutical supply chain."

"However, it is our understanding that some supply chain participants are facing difficulties meeting DSCSA's full implementation requirements," the letter states. "Based on what we are hearing from healthcare supply chain stakeholders about readiness for the November 27th deadline, absent government intervention, there will likely be disruptions that could lead to patient access problems and further drug shortages."

They're urging the FDA to ensure that DSCSA requirements do not disrupt the drug supply chain.

The members issued a joint press statement, which includes support from the nation's major supply chain and pharmacy associations.

The letter is endorsed by the Healthcare Distribution Alliance, American Pharmacists Association, National Association of Boards of Pharmacy, National Community Pharmacists Association, and National Association of Chain Drug Stores.

Kristen Freitas, director of Federal Government Affairs for the Healthcare Distribution Alliance (HDA), praised lawmakers for pressing "the FDA to ensure that the final implementation of DSCSA is done efficiently and effectively to minimize the very real, yet avoidable, risk to patient care if the supply chain is disrupted."