Regulatory Focus™ > News Articles > 2020 > 10 > FDA delays enforcement of some DSCSA provisions by three years

Regulatory NewsRegulatory News
Posted 26 October 2020 | By Michael Mezher 

FDA delays enforcement of some DSCSA provisions by three years

3065 The US Food and Drug Administration (FDA) last week announced it will again delay enforcement of a provision of the Drug Supply Chain Security Act (DSCSA) that would require wholesalers to verify saleable returned drugs they intend to further distribute.
“FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under section 582(c)(4)(D) of the [Federal Food, Drug, and Cosmetic Act] FD&C Act,” FDA writes.
The provision was originally slated to take effect last November, but FDA announced it would delay enforcement by one year in September 2019. (RELATED: FDA delays verification requirement for salable returned drugs, Regulatory Focus 24 September 2019).
FDA explains the latest enforcement delay in an immediately effective procedural guidance that also delays two other provisions of the DSCSA that were set to take effect next month by three years.
Those two provisions, which apply to drug dispensers, require verification of the product identifier of suspect or illegitimate product in the dispenser’s possession or control. Specifically, those provisions would require dispensers to verify the product identifier of a certain amount of suspect product against the product identifier assigned to the product by the manufacturer or repackager and to verify product in response to a notification of illegitimate product from FDA or a trading partner.
FDA explains that since it issued the 2019 compliance policy, it has received comments from wholesale distributors and others, “Expressing concern with industry-wide readiness for implementation of the verification of saleable returned product requirement for wholesale distributors and the challenges stakeholders face with developing interoperable, electronic systems to enable such verification and achieve interoperability between networks.”
The comments also highlighted challenges testing verification systems and the competing priority of responding to the COVID-19 pandemic as reasons justifying the delay.
FDA notes that the three-year delay will align the saleable returned product verification requirement with the 2023 deadline for an enhanced drug distribution security system set out in section 582(g) of the FD&C Act.
“Instead of developing separate processes or infrastructures solely for the saleable return verification requirement, wholesale distributors can incorporate the saleable return verification requirements into enhanced verification required by 2023,” FDA writes, providing a similar logic for delaying enforcement for the two dispensing provisions.
Manufacturers and repackagers, who sought to broaden the scope of the enforcement delay, are left out by the new policy.
FDA, Federal Register Notice


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found