Drugs

DSCSA Can Lead to Drug Shortages: Reps

A bipartisan group of 28 members of the House of Representatives is warning FDA that the 11/27 deadline for implementing provisions of the Drug Supply Chain Security Act (DSCSA) could lead to disruptions to drug supply and patient care. The group is led by Reps. Troy Balderson (R-OH) and Ann Kuster (D-NH).

In a statement (contains a link to the letter), Balderson says the group is highlighting “issues facing pharmaceutical manufacturers, distributors, and dispensers as they work to bring the drug supply chain into compliance with DSCSA requirements. Beginning 11/27, all drugs must be able to be tracked electronically on the unit level. Any drugs that do not comply with the new requirements cannot be distributed or dispensed to patients. While well-intentioned, it is critical FDA ensures that DSCSA requirements do not lead to shortages of life-saving drugs for Americans.”

The representatives say they understand that some supply chain participants are facing difficulties meeting DSCSA’s full implementation requirements. “Based on what we are hearing from healthcare supply chain stakeholders about readiness for the 11/27 deadline,” they write, “absent government intervention, there will likely be disruptions that could lead to patient access problems and further drug shortages.”

The letter asks for FDA responses to five questions on how FDA is tracking the situation, the potential ramifications of DSCSA noncompliance, and whether FDA plans to issue further guidance on enforcement policies.

The letter says Balderson and Kuster have support from the Healthcare Distribution Alliance, American Pharmacists Association, National Association of Boards of Pharmacy, National Community Pharmacists Association, and National Association of Chain Drug Stores.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome