FDA Extends Dispenser Delay in DSCSA Enforcement

Early this morning the FDA published a revised version of its “DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy“, originally published on July 6, 2015 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“).  That original document established the FDA’s intention to exercise “enforcement discretion” on dispenser transactions that

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3 thoughts on “FDA Extends Dispenser Delay in DSCSA Enforcement”

    1. Jason,
      It appears that this delay does not have any impact on the wholesaler’s requirement to provide TI, TH and TS to their customers at the time of shipment. I base that opinion on the language in the new guidance where it says:

      “This compliance policy does not extend to the requirements under section 582(b)(1), (c)(1), and (e)(1) that other trading partners (manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers.”

      I think that’s pretty definitive, but I am not a lawyer!

      Dirk.

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