FDA puts back DSCSA deadlines by three years

The FDA has extended the enforcement holiday for a Drug Supply Chain Security Act (DSCSA) deadline once again, setting it back by three years.

The saleable returns verification requirements was originally due to come into effect in November 2019, but the FDA has now confirmed that it won’t be requiring compliance with the regulation until November 27, 2023.

The agency said that it had been advised of challenges stakeholders were facing with developing “interoperable, electronic systems to enable such verification and achieve interoperability between networks,” according to a Federal Register notice.

The DSCSA provision covering saleable returns requires wholesalers and distributors to verify the serialised unique identifiers of returned products before they can be placed into inventory for resale.

Last year, the US regulator announced a one-year enforcement delay to the deadline, but there are still concerns that the industry is not fully ready to comply. That could lead to perfectly good medicines being quarantined or destroyed, potentially leading to drug shortages.

The single biggest reason for returned medicines is the overstocking by dispensaries, and it is estimated that there are around 60m saleable returns each year, equating to around $11bn-worth of drugs.

The FDA said it had received comments saying that wholesale distributors needed more time to test verification systems using real-time volumes of saleable returned product.

The decision was welcomed by the Healthcare Distribution Alliance (HDA), which represents primary pharmaceutical distributors in the US. It said in a statement that the industry’s efforts to comply with the saleable returns requirements had been hampered by the COVID-19 pandemic.

“Rest assured, industry, and HDA as its convener, will work to leverage the immense effort, learnings and investments made to date to comply with the serialised saleable return deadline as we work toward the ultimate goal of 2023 DSCSA interoperability,” it said in a statement.

Dispenser deadline also affected

Meanwhile, the FDA says it also won’t be taking any action against “dispensers who do not verify the statutorily-designated portion of product identifiers of suspect or illegitimate product” before that date.

That applies to a DSCSA provision that requires dispensers to verify at least three packages or 10 per cent of any suspect product, whichever is greater, or all packages if there are fewer than three.

That’s not to say that the requirements can now be entirely ignored for three years. The FDA still says it will be looking for signs that the industry is acting in good faith to move towards compliance, and that means there could potentially still be legal liability if something were to go awry.