In the new U.S. Drug Supply Chain Security Act (DSCSA) enacted last November as part of the Drug Quality and Security Act (DQSA), “Transaction Information” (TI) is one of three primary sets of data that supply chain sellers of drugs must provide to the buyers beginning January 1 of next year. I will discuss “Transaction History” (TH) and “Transaction Statements” (TS) in future essays.
On first look, TI can seem pretty simple. Here is how the DSCSA defines it:
“(26) TRANSACTION INFORMATION.—
The term ‘transaction information’ means—
“(A) the proprietary or established name or names of the product;
“(B) the strength and dosage form of the product;
“(C) the National Drug Code (NDC) number of the product;
“(D) the container size;
“(E) the number of containers;
“(F) the lot number of the product;
“(G) the date of the transaction;
“(H) the date of the shipment, if more than 24 hours after the date of the transaction;
“(I) the business name and address of the person from whom ownership is being transferred; and
“(J) the business name and address of the person to whom ownership is being transferred.”
Sounds kind of like a delivery manifest or packing list.
The FDA will almost certainly provide additional guidance on how to represent some of these data elements at the time they publish their draft guidance establishing the standards for the interoperable exchange of TI/TH/TS in paper or electronic format on or before November 27, 2014 (see “Decoding The FDA’s DSCSA Timeline”).
Last week I attended the Healthcare Distribution Management Association (HDMA) Distribution Management Conference (DMC). During the Distributor Traceability Updates session, representatives from the top four wholesale distribution companies in the U.S. talked about their work in a closed-door HDMA work group that is currently working on guidance for communicating TI/TH/TS. They expect to publish their guidance sometime in the next month or so, which means it will not have the benefit of the FDA guidance. That means that they will be making their best guess about what will be acceptable to the FDA. But given the unfortunate time constraints (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act“), I think this is the right thing for them to do (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“, and “DQSA: Getting To Electronic Transaction Data Exchange“). Watch for that guidance soon.
WHAT MORE DO YOU NEED TO KNOW?
Just a few things. In the FDA’s guidance document, I hope they explain:
- how, why and when you might want to indicate multiple “names” of a given product;
- how to format the strength and dosage form, including units and any abbreviations or standard terms/codes that should be used;
- the formatting of the NDC, including:
- whether or not a 14-digit GS1 GTIN that contains the NDC and that matches the identifier contained in the 2D barcode that will eventually be printed on the package (by November 27, 2017);
- confirmation that it is the 10-digit NDC and not the 11-digit “pseudo-NDC” used for reimbursement claims; and
- whether or not to use dashes in the number;
- confirmation that “the container size” is the package size (and not the shipping container size) and what standard terms/units and abbreviations are allowed;
- confirmation that “the number of containers” is the total number of drug packages of the given NDC that are included in the overall transaction and that this is irrespective of the number of packages in each shipping container;
- how to indicate multiple lot numbers for the same NDC in the transaction and how that relates to how “the number of containers” data is represented;
- how to properly format the date of the transaction and the date of the shipment;
- whether the business names and addresses must/may equal the exact shipping dock address (including that of a 3PL), or if they must/may be the address of the owner’s headquarters;
- whether or not and how this information can be segmented in such a way that the “to” and “from” business names and addresses occur only once in a TI document that reflects a single transaction but which includes multiple NDCs and multiple lot numbers for each NDC;
Those are mostly all formatting questions—and the answers from the FDA might be different for paper than they might be for the electronic version—but there are deeper questions. Some people are wondering whether or not the electronic version can make use of GS1’s Global Location Number (GLN), and/or perhaps a Data Universal Numbering System (DUNS) number (see “FDA Chooses DUNS For Unique Facility Identifier”), in place of the business names and addresses.
When does the “transaction”, or “change-of-ownership” actually take place? Is it when the buyer’s purchase order is accepted by the seller, the moment the shipment takes place at the seller’s (or their 3PL’s) loading dock, or does it depend on the Freight On Board (FOB) (also called “Free On Board”) terms? (See “Pedigree Will Change FOB Terms”.) My understanding of FOB terms is that they make it clear exactly when the product changes ownership. If the buyer and seller agree to FOB terms of “Destination”, how does the seller know what date to put into the “date of transaction” field?
The DSCSA defines “transaction” to mean “…the transfer of product between persons in which a change of ownership occurs…”. What happens when the physical “transfer” is separated by days, weeks or even months from the “change of ownership”? This is what happens in the business practice known as Vendor Managed Inventory (VMI). In VMI, a manufacturer or wholesale distributor owns the product sitting on the inventory shelves of a dispenser and the ownership changes to the dispenser only at the moment the drug is dispensed to a patient (see “Vendor Managed Inventory Under California ePedigree”).
In this case, since the product sitting on the pharmacy shelf is still owned by the manufacturer or wholesale distributor, is there any need to provide TI/TH/TS when the product is shipped (physically “transferred”) from the seller’s location to the eventual buyer’s location? Remember, the change of ownership has not yet occurred. And when the change of ownership does occur at the time the drug is dispensed to the patient, no physical “transfer” occurs. I assume the answer is “no”, but I wonder what the FDA thinks.
Up to a point, this has some parallels with the way a 3PL works and the DSCSA makes it clear that shipments into and out of a 3PL are exempt from the TI/TH/TS requirements as long as the 3PL does not take ownership.
When the sales transaction does occur in the VMI situation, what business name and address goes in the “from” and “to” fields? The names and addresses where the transaction took place, or the names and addresses of the parent companies involved? How/when must the TI/TH/TS be delivered to the dispenser?
Lots of questions for the FDA to answer just about TI. Maybe you can think of a few more. The deadline for submitting questions and comments to the FDA regarding the draft guidance they will publish next November through the docket is April 21, 2014 (see “DQSA: How Should Transaction Data Be Exchanged?“).
In case you missed it, the FDA held a webinar last Thursday that included an overview of the DSCSA. Listen to the recording and download the slide deck here. I thought Congress specifically prohibited the FDA from holding public meetings regarding the DSCSA until November 27, 2014 [see section 582(i)(1)], but during the presentation Dr. Illisa Bernstein said that they would announce a public meeting soon. Apparently this one will not count as one of the five they are mandated by the DSCSA to hold.
If your job requires you to understand the DSCSA, make sure you check out my new PDF document “The Drug Supply Chain Security Act Explained”. Sales of the single user license are proceeding well since I published the book one week ago (see “The Drug Supply Chain Security Act Explained”), but I was disappointed with the sales of the Corporate licensed version.
The book is a great tool for company teams to use to come up to speed quickly on the law and I really want teams to feel that they can share the document, but you can only do with the Corporate licensed version. So I lowered the price of the Corporate license significantly last Thursday. My bad for pricing it out of reach initially. If you saw the price earlier in the week and were disappointed, make sure you check it out again. I think you will be pleased.
To all of you who purchased a copy this week, thank you. Let me know what you think.