As you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”). This is a major move by the FDA and it will have important consequences for the industry. Let’s break it down.
The draft guidance will officially be published in the Federal Register today but the early announcement of it was published last Friday. The FDA will collect comments on the draft from the public for sixty days, and then they will (probably) publish a final version at some time after that. Technically it does not take effect until the final guidance is published, but in this case, I think it is reasonable assume the enforcement delays spelled out in the draft will remain when the final version comes out. But, be aware, that is always a possibility that they won’t, or that the FDA will never publish a final document. Keep that in the back of your mind when you think about submitting a comment. Do you like the delay? Do you want a longer delay? If so, then you should submit a comment to let them know.
SERIALIZATION AND VERIFICATION DELAYED
The main purpose of this draft guidance is to propose a delay in enforcement of the requirement to apply the new DSCSA product identifier on drug packages and homogeneous cases (see “The DSCSA Product Identifier On Drug Packages”). But once the FDA does that, they must also delay enforcement of a number of other manufacturer requirements, including the need to begin verifying drug packages and homogeneous cases using the Standardized Numerical Identifier (SNI) contained in the new product identifier, rather than just the lot number. The SNI contains the serial number (see “FDA Aligns with GS1 SGTIN For SNDC”).
In fact, almost all of the manufacturer requirements set to go into effect on November 27, 2017 would not be enforced for the proposed one year delay. It is easier to list the requirements that will still go into effect on that date than to list those that are affected by the delay. Here are all of the new DSCSA manufacturer requirements that would still go into effect on that date and be fully enforced:
- Manufacturers must begin to provide the transaction information, transaction history and transaction statement in electronic format only, except when selling directly to a licensed healthcare practitioner who is authorized to prescribe medication under State law, or to other licensed individuals who are under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice. [see Section 582(b)(1)(C)]
CASCADING ENFORCEMENT DELAYS
By not enforcing the manufacturer’s requirement to apply the new DSCSA product identifier on all drug packages by this November the FDA is forced to soften some of the deadlines for other segments of the supply chain. And here is where things get a little complex. Repackagers, wholesale distributors and dispensers each have their own DSCSA requirement not to engage in transactions that involve products that do not have the DSCSA product identifier on them. And each segment also has enhanced requirements for verification of suspect product and saleable returns (see “DSCSA: Saleable Returns Verification”). Those requirements all kick in on November 27 of 2018, 2019 and 2020 respectively.
Rather than not enforce these deadlines for a comparable one year delay, the new draft guidance makes it clear that these deadlines will still be enforced for product that the manufacturer introduced into commerce with the new DSCSA product identifier before November 27, 2017. For example, as the FDA puts it for the enhanced verification requirements, “If a product has a product identifier, FDA expects manufacturers, and downstream trading partners to use it in verification” (see “Drug Verification: EU Vs US”).
Interestingly, this draft guidance would not affect the requirement for repackagers to apply a DSCSA product identifier to repackaged products by November 27, 2018. That deadline would still stand (for now at least) (see “Repackaging Drugs Under A Serialization Regulation”).
So now, according to the draft, enforcement or non-enforcement of subsequent deadlines on downstream trading partners will depend on whether or not the product without a DSCSA product identifier was first introduced into commerce by the manufacturer between November 27, 2017 and November 26, 2018. If it was, then the FDA will not enforce those specific downstream requirements. If the product was introduced into commerce after November 26, 2018 (or if the product has a DSCSA product identifier on it) then the full DSCSA requirements would be enforced. That means we need a way to identify exactly when a given product was first introduced into commerce by the manufacturer.
FDA proposes two ways to do that. One is to use the Transaction Information documents contained within the Transaction History to determine the date of first introduction into commerce by the manufacturer (see “DSCSA: Transaction Information” and “DSCSA: Transaction History”). The other is use non-DSCSA documentation that clearly describes the products and indicates when the manufacturer introduced them into commerce. These may include things like bills of lading, commercial invoices and shipping invoices, but could include other types not listed. Companies buying drugs after their DSCSA deadline would need to study these documents to determine if products that do not have a DSCSA product identifier on them would be in compliance. You might want to ask ahead of time so you don’t receive shipments containing non-compliant drugs.
How will all this impact “grandfathering” (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”)? Hard to say, but at least the FDA recognizes that things will now be more complex. The last section of the draft guidance indicates that the FDA intends to address that impact someday when they finally publish the mandated grandfathering guidance document. That will be interesting.
Why doesn’t the FDA just announce new deadlines for these sections of the DSCSA? Because the DSCSA is a law and the dates of each deadline contained within it were set by Congress (see “Will President Trump Eliminate The DSCSA?”). Only Congress can change the dates, but because the FDA is the agency that enforces this law, they can choose to enforce it selectively—particularly “[t]o minimize possible disruptions in the distribution of prescription drugs in the United States”.
There is a lot I haven’t covered in this brief look at the draft guidance. I’ll have more to say about it in the coming weeks. Make sure you read it and submit a comment so the FDA knows how you feel about it. Also, notice that this still isn’t one of the four guidance documents that were due back on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”), but maybe this indicates that some internal logjam has been broken. Maybe we’ll start seeing one DSCSA guidance each week. Still not holding my breath.