FDA denies DSCSA delay sought by dispensers

Pharmacies and other dispensers in the US will have to comply with medicine track-and-trace obligations coming into effect this month under the Drug Supply Chain Security Act (DSCSA), the FDA has confirmed.

The American Pharmacists Association (APhA) – the largest association of pharmacists in the US – had sought to delay the enforcement of a DSCSA requirement that dispensers buy and sell only products with a product identifier on their packages that features the products’ National Drug Code (NDC) plus a unique serial number, lot number, and an expiration date.

Dispensers have to ensure the product identifier is on the packages of most products when they receive them, but are not yet required to scan product barcodes upon receipt.

“The challenge for dispensers is that not all drug product packages are required to have a product identifier, and there is no central database to check if a product should have one,” said Ilisa Bernstein, APhA senior vice president of pharmacy practice and government affairs.

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“If unsure, check with the manufacturer to see if a product identifier should be on the package,” she advises.

Last month, the FDA said it would not enforce other requirements due to come into force on November 27, including a 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.

The agency will not act against dispensers who do not comply with the requirement before November 27, 2023.

“For suspect and illegitimate product, dispensers must still quarantine product, conduct investigations, and disposition illegitimate product,” Bernstein said.