Washington, D.C.—Nearly a decade ago, the Drug Quality and Security Act (DQSA) was enacted by Congress in an effort to enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Congress mandated that all U.S. prescription drug supply chain trading partners meet the DSCSA’s final requirements no later than November 27, 2023. By that date, manufacturers, distributors, and dispensers were told to begin interoperably and electronically exchanging data identifying each prescription drug package purchased and sold.

The problem according to the Healthcare Distribution Alliance (HDA), a national organization representing primary pharmaceutical distributors, is that “this complex capability to trace at the serialized individual package level does not exist today. Currently, prescription drugs can only be traced at the lot level.”

As a result, in early June the HDA sent a letter to the FDA recommending a phased approach to final implementation of the SDCSA to minimize the potential for supply disruptions and interruptions to patient care.

Later in the month, three key associations representing pharmacists also chimed in with a request that “FDA use its authority under the law for dispensers to comply with the EDDS [enhanced drug distribution security] requirements no earlier than February 27, 2026.”

The American Pharmacists Association, the National Association of Chain Drug Stores, and the National Community Pharmacists Association also recommended a phased, stepwise approach to the implementation of the EDDS requirements of the DCSCA.

“The action would go a long way in helping to minimize the potential for supply disruptions and ensure that there are no interruptions to patient care,” the groups pointed outed.

The groups stated, “Our member organizations support a phased, stepwise approach to ensure that all sectors of the pharmaceutical supply chain have adequate time to stabilize the complex systems and processes necessary for efficient transactions across the supply chain. To be clear, our support for this approach is not to delay all implementation activity. We believe during the phased period it is important for trading partners to continue on the path toward package-level tracing and enhanced supply chain security Congress envisioned when it enacted the DSCSA ten years ago.”

A key concern is the ability of pharmacies and pharmacists to purchase medications from manufacturers and wholesalers when that is “completely reliant” on their ability to comply with DSCSA requirements.

“The inability to be ready by November 27 would cause significant risk to patients’ access to their lifesaving medications,” the pharmacist groups maintained. “If upstream trading partners cannot accurately exchange interoperable package-level data to subsequently provide to dispensers, then the DSCSA is structured to prohibit dispensers from purchasing such product to meet their patients’ needs. This could potentially cause significant harm and drug shortages for patients who rely on these medications.”

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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