New DSCSA dispenser rules come into play tomorrow

The FDA recently deferred enforcement of a series of Drug Supply Chain Security Act (DSCSA) requirements, but some are still in play and come into force tomorrow.

Starting November 27, for example, pharmacies in the US must buy and sell only products with a required product identifier on their packages, part of the phased implementation of DSCSA building towards a full track-and-trace system by the end of 2023.

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, according to Ilisa Bernstein, senior vice president of pharmacy practice and government affairs at the American Pharmacists Association (APhA).

The APhA – which is the largest association of pharmacists in the US – had sought to delay the enforcement of this provision of the DSCSA, but that was denied by the regulator.

“If unsure, check the transaction statement to see if a product identifier should be on the package,” says Bernstein, noting that should allow them to confirm from the seller that the product and information surrounding the sale are accurate, including that a suspect or illegitimate product was not knowingly shipped.

Most products packaged by manufacturers after November 27, 2018—although not all—must be affixed or imprinted with a product identifier that features the product’s National Drug Code (NDC), plus a unique serial number, lot number, and expiration date.

In October, the FDA delayed until November 27, 2023 a requirement that dispensers should verify product identifiers when investigating suspect or illegitimate medicinal produce, along with other aspects of the DSCSA including saleable returns verification requirements.

Pharmacists who encounter products without a product identifier should determine whether the product is grandfathered because it was made before the DSCSA labelling requirements came into effect, or because it is in an exempt category such as blood products, radiopharmaceuticals, medical gases or homeopathic medicines.

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