As 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?
IT MEANS NOTHING
You could easily make the argument that, with this new revised guidance and the delay in FDA enforcement, supply chain entities like drug manufacturers, wholesale distributors and repackagers who ship drugs to dispensers are also off the hook when it comes to providing the recipient with the DSCSA mandated Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) documentation. I seems logical. If the FDA is not going to enforce the requirement for the dispenser to receive that documentation, then why would they enforce the requirement for the seller to provide it to them?
You could make that argument, but you would be wrong. In fact, the FDA is currently enforcing the DSCSA requirement that sellers provide buyers–including buyers who are dispensers–with TI, TH and TS. That enforcement began on May 1 of this year (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1“).
It is clear from the wording of the newly revised guidance document that the FDA wants to be clear about this point. 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.”
But the agency goes even further in clarifying that even when a dispenser is the seller, TI, TH and TS must be provided to the buyer (except for returns or to meet a “specific patient need”).
“In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history, as required by section 582(d)(1)(A)(ii).”
This will likely complicate the situations where a dispenser sells some drugs to another dispenser if the selling dispenser did not accept and save the transaction information from their supplier during this period of enforcement discretion.
The extension in enforcement of the dispenser data exchange requirement by the FDA will be a great relief for the majority of dispensers as they continue to prepare to meet the law, but drug manufacturers, wholesale distributors and repackagers should pay no attention to it.
Over the last few days I have converted RxTrace.com to only use Secure HyperText Transport Protocol (HTTPS) instead of just HTTP. You shouldn’t notice any real difference, but HTTPS is more secure. All data passed between the RxTrace.com servers and your browser are now encrypted. Many of your favorite websites will be doing the same thing over time, as Google, Yahoo, Amazon and others already have. Now RxTrace is in that camp.
If you experience any unexpected behavior all of a sudden, let me know. This is just one of a series of important updates I am making on RxTrace over the next few months. Watch for more.