Drug manufacturers facing the November 27, 2017 deadline for applying unique identifiers to their products should take care when interpreting the FDA’s recent draft compliance policy. All the headlines scream (including last week’s RxTrace essay: “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) that the Drug Supply Chain Security Act (DSCSA) serialization deadline is delayed, but there are important nuances to the delay. Don’t just read the headlines, read the whole articles. Officially, the deadline remains the same. Yes, the FDA will look the other way for some drugs, but for others, the deadline still appears to apply. How do you know if your drugs are those where the deadline still applies? Read on.
First, so far, it’s only a draft. It will almost certainly be finalized. Almost certainly. But it’s not final until the FDA collects comments over the next 60 days (now 53 days), and then they publish the final document. They could end up changing the text, just for clarity, or for substance. For example, if they collect enough convincing evidence in the public input, they could…I said they could…even make the enforcement delay longer than just one year.
I’ve argued elsewhere that the delay should be as long as the four overdue guidance document have been late. That’s now more than 19 months and counting. The justification is that Congress set the deadline of November 27, 2015 for the FDA to publish those guidances so that you would have two full years to use their contents to develop strategies, design your systems and apply for waivers, exemptions and exceptions as needed. You’ve been denied that time by the FDA withholding those guidance documents until just before the original deadline. Is one extra year of the-FDA-looking-the-other-way going to replace that mandated guidance timeline? Let them know in your comments.
Second, as I interpret it, if a manufacturer begins shipping serialized product on or before November 27, 2017, the delay in enforcement does not apply to those products. Why would it, right? After all, the delay is for drugs that are NOT serialized by that date.
Yes, but remember that the delay also applies to the enforcement of verification. And here the draft policy can appear to be inconsistent. On the one hand it says the following:
“FDA does not intend to take action against a manufacturer who initially introduces product in a transaction into commerce without a product identifier between November 27, 2017, and November 26, 2018, and:
does not verify product without a product identifier, at the package level, in situations where such verification is required by section 582(b)(4)(A)(i)(II) of the FD&C Act ( i.e., the manufacturer has determined that such product is a suspect product or it has received a verification request for such product from the FDA);
does not, upon receiving a request from an authorized trading partner, verify a product without a product identifier, as required by section 582(b)(4)(C) of the FD&C Act (i.e., the manufacturer has received a request for verification from an authorized trading partner that is in possession or control of a product that such trading partner believes to be manufactured by such manufacturer); or
does not verify a package or sealed homogenous case of product without a product identifier that is intended for further distribution as a saleable returned product, as required by section 582(b)(4)(E) of the FD&C Act.”
On the other hand, it says:
“If a product has a product identifier, FDA expects manufacturers and downstream trading partners to use it in verification.”
Don’t be confused by the FDA’s use of the phrase “…initially introduces product…” in the first extract above. I don’t think they are only referring to new products that are introduced for the first time during that one year period. Remember, the term “Product” has a very specific meaning in the DSCSA. So do the terms “transaction”, “product identifier”, “verify/verification”, and even “manufacturer”. To fully understand the statements above—let alone the entire guidance—you need to know those and other DSCSA-specific definitions.
Clearly the best advice from the entire document is, if the product package has a “product identifier”—that is, if it has the DSCSA-mandated 2D barcode on it—then you must verify it using the serial number whenever the original DSCSA text requires it after November 27 of this year. The “delay” does not apply to that specific package. For those packages, the song remains the same.
And the same is true as that product moves down the supply chain, but that brings up even more confusion. I’ll write about that next week.
RxTRACE REMAINS THE SAME TOO
Last week was the eighth anniversary of the first RxTrace essay (see it here “Welcome to rxTrace”). And this is the 456th essay published since then. That’s a lot of writing, and a lot of reading for those first few followers who are still with me, including Phil Taylor, Dan Steiber, G. Weiss, Shawn Slattery and George Kuntz. Thanks to those and all of my readers and subscribers for making RxTrace a success for these last eight years.
We have a long way to go, so stick with RxTrace. I will continue covering the DSCSA, FMD and pharma traceability all around the globe. This song remains the same.