Tag Archives: enforcement discretion

DSCSA

No Surprise: DSCSA Verification Delay

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Dr. Ilisa Bernstein leaves FDA for APhA

It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”).  The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.

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DSCSA

Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

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On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch.  They are required to:

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Dispensers, DSCSA

FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders

iStock_000022846474_smallerBack in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  That was itself an additional four month extension to the four month enforcement discretion they originally announced on June 30 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“).  Many dispensers were hoping for another extension in these last few days of February.  It turns out, the enforcement discretion will be extended until further notice, but apparently mostly just for first responders. Continue reading FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders →

DSCSA

Pay No Attention To The Enforcement Delay Unless You Are A Dispenser

iStock_000037865140_smallerAs I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  What does this mean for drug manufacturers, wholesale distributors and repackagers? Continue reading Pay No Attention To The Enforcement Delay Unless You Are A Dispenser →