Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”). The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”. That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA. It is an unfunded mandate.
Fortunately the FDA is Continue reading FDA DSCSA Deadline Passes Quietly
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 fall under the Drug Supply Chain Security Act (DSCSA) dispenser requirements to receive Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement.
The revision published today pushes Continue reading FDA Extends Dispenser Delay in DSCSA Enforcement
Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet. When allowed, grandfathering allows a company to continue doing something after a regulatory deadline that mandates a change, as long as one or more pre-conditions apply. For example, Section 582(a)(5)(B) of the Drug Supply Chain Security Act (DSCSA) allows wholesale distributors, and repackagers to sell drugs that were already within the supply chain on January 1, 2015 without passing the necessary transaction data. This makes sense because companies were not obligated to supply that data before that date and so some of the assertions required in the Transaction Statement would not be true (among other problems that grandfathering eliminates). [Of course, Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?
The FDA updated their website this morning with new guidance that indicates they intend to use enforcement discretion by not enforcing the dispenser requirements to accept and capture Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement. The document indicates that the FDA’s decision to take this action was based on the fact that “…some dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date.” Continue reading FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015
I was poking around on the FDA website yesterday to find out if any new DSCSA documents had been released recently. I just returned from a near three-week trip to Western Europe and wanted to see if perhaps I missed something. No. Nothing released recently. You can find a list of DSCSA documents released by the FDA on their website and the most recent one was published on December 31, 2014.
Back in January of this year the FDA published their annual list of guidance titles that they think they will publish in the coming year (updated in April). That list included six titles of guidance documents related to the DSCSA that they expect to either publish in draft form, or finalize. These include: Continue reading FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015