FDA hands dispensers a two-year DSCSA delay

The FDA has said it will give small dispensers a two-year extension to comply with the enhanced tracking requirements for prescription medicines under the Drug Supply Chain Security Act (DSCSA).

The delay applies to the FDA’s enforcement of enhanced drug distribution security requirements and verification requirements for dispensers that come across suspect or illegitimate products, which were laid out in guidance published last year.

The new enforcement holiday comes on top of a one-year delay to the deadline of November 27, 2023 – intended as a “stabilisation period” to give trading partners in the pharma distribution supply chain more time to “implement, troubleshoot and mature” DSCSA systems – and means that small dispensers are now exempted until November 27, 2026.

In its update, the FDA said it will also consider waiver or exemption requests from other trading partners that are not ready to implement these systems by November next year.

“Small dispensers have described challenges related to the time, costs, and resources needed to further develop the robust technologies and processes to enable data exchange, establish business relationships with their trading partners, and operationalise business practices,” said Michael Levy, deputy director of the Office of Compliance in the FDA’s Centre for Drug Evaluation and Research (CDER).

The agency defines a small dispenser as one that has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.

It has been more than a decade since the DSCSA was enacted in 2013 to require trading partners along the pharma supply chain – from drug manufacturers to pharmacies – to deploy traceability systems that allow prescription medicines to be tracked at the pack level, using serialised codes.

The objective of the DSCSA is that manufacturers can respond in real-time to queries about the legitimacy of a product, to improve the security of the supply chain and prevent counterfeit and otherwise illicit medicines from reaching patients.

Levy stressed that the exemptions “are not intended to provide, and should not be viewed as providing, a justification for delaying efforts by small dispensers to implement the enhanced drug distribution security requirements.”