The second—and longer—draft guidance document the FDA published on the day of the third DSCSA public meeting is a “catch-all” (see also “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations” and “FDA DSCSA Public Meeting #3: A Difference?”). It contains lots of diverse recommendations, all related to the standardization of data contained in the DSCSA transaction information (TI), transaction history (TH), and transaction statement (TS). This draft guidance applies to every member of the supply chain, including drug manufacturers, CMOs, 3PLs, wholesale distributors, repackagers and dispensers of all kinds. Everyone should read it and submit comments to the FDA when something isn’t clear enough.
For more about what “draft guidance” is, see “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations”.
To best cover this guidance, I’m going to run through it section-by-section offering brief comments on each one. Find the full guidance document here.
Notice how many footnotes this guidance document contains. That’s because they need to refer to so many specific sections of the DSCSA. It’s hard to write about the DSCSA without doing that. This draft guidance makes use of many terms that were originally defined within the DSCSA, so like the original DSCSA, you can’t really understand this draft guidance without knowing those definitions and keeping them in mind as you read it (see “Don’t Skip The DQSA Definition of Terms Section”).
According to the introduction:
“This guidance is intended to assist trading partners in standardizing the product tracing information that is captured, maintained, and provided to the subsequent purchaser, FDA, or other appropriate State or Federal officials pursuant to the requirements under section 582 of the FD&C Act. This guidance is also intended to help trading partners understand the data elements that should be included in the product tracing information, particularly in situations where trading partners are permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required.”
Because this draft guidance covers so many special situations, it has some similarities with the Healthcare Distribution Alliance’s (HDA) DSCSA Scenarios document from a few years ago (see “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”). More on that later.
TRADING PARTNER CLARIFICATIONS
The first substantive section of the draft guidance makes a few clarifications about DSCSA manufacturers and DSCSA dispensers. For manufacturing situations where there are multiple entities that fall under the DSCSA definition of “Manufacturer”, FDA recommends that these entities specify in a written agreement which of them will carry out the activities mandated by the manufacturer section of the DSCSA. When questions arise later, the agreement will make it clear who is involved.
The guidance provides clarity for DSCSA dispensers around several specific situations, including dispenser to dispenser sales to fulfill a specific patient need, exception for licensed health care practitioners and third-party agreements. That last one addresses the ability for dispensers to enter into a written agreement with a third-party to receive and hold their DSCSA transaction data on their behalf. The guidance provides much needed explanations for the obligations that result, including the upstream trading partner sending data, the third-party, and the dispenser themselves.
STANDARDIZATION OF DATA
This is the longest section of the draft guidance. It provides a wealth of clarity around many of the data elements of the TI as well as exactly how to structure the TH, and the long-awaited abbreviations for the TS.
The Transaction Information (TI) data elements covered include:
- Proprietary or established name of the product
Every owner in the supply chain should use the name provided in the original manufacturer or repackager’s TI. Don’t truncate it unless you have to.
Every owner in the supply chain should use the strength and unit of measure provided the original manufacturer or repackager’s TI. Guidance is provided for abbreviating the units of measure.
- Dosage form
Every owner in the supply chain should use the dosage form provided in the original manufacturer or repackager’s TI. Guidance is provided for abbreviating.
- National Drug Code Number of the product
Here the length of the NDC is specified as a three-segment number, but also reminds everyone that some human cells, tissues and cellular and tissue-based products (HCT/Ps) may use an alternatively formatted NDC. More on this can be found in the Standardized Numerical Identifier (SNI) guidance (see “FDA Aligns with GS1 SGTIN For SNDC”). Every owner in the supply chain should use the NDC provided in the original manufacturer or repackager’s TI.
- Container size
The container size should reflect the packaging configuration of the “individual saleable unit”. This is the number of “dosage forms” per “container”. Everyone always assumed this was the case, but it’s nice to see it spelled out by the FDA.
- Number of containers
This is the quantity of individual saleable units of a product of the same lot number included in a transaction. If multiple lots of the same product are included in the transaction, then they should be listed in multiple records or in separate TIs.
- Lot number of the product
Every owner in the supply chain should use the lot number provided in the original manufacturer or repackager’s TI.
- Date of the transaction
If specified in a contract, use the specified date, otherwise use the shipping date.
- Date of the shipment, if more than 24 ours after the date of the transaction
- Business name and address of the person from whom ownership is being transferred
This was a bit of a surprise. FDA leaves it up to the business to decide whether to provide the address of the corporate headquarters, the billing address, or the shipping address of the facility. They recommend using the address of the shipping facility, but if the product is being shipped from a 3PL, they want you to use the business address of the owner, NOT the address of the 3PL.
- Business name and address of the person to whom ownership is being transferred
This is comparable to the recommendations above.
Regarding the Transaction History (TH), the draft guidance says that the TH may be provided either as a collection of separate TI documents going back to the original manufacturer or repackager, or as a single document that is “…based on the documentation it has received from the product’s previous owner.” If you do the latter, FDA just wants to make sure the data is “accurately transcribed”.
Regarding the Transaction Statement (TS), the draft finally confirms what HDA has been recommending for several years now. Rather than printing out all seven of the assertions specified in the DSCSA for the TS, just print the following text somewhere in the electronic documentation you provide to the buyer:
“For this transaction, [Insert name of trading partner transferring ownership] is in compliance with section 581(27)(A)-(G) of the Federal Food, Drug, and Cosmetic Act.”
That is similar to the text recommended by the HDA (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”). Your wording may differ slightly, but remember, FDA guidance allows for that as long as you meet the law.
For companies selling drugs that were the subject of a “direct purchase”, the DSCSA requires an additional assertion to go along with your TS. This draft guidance suggests this text:
“[insert name of wholesale distributor that made a direct purchase] purchased this product directly from the manufacturer, exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer.”
Wholesale distributors transferring ownership of a product purchased from another wholesale distributor that made a direct purchase of the product can use the following text, assuming they received a direct purchase statement from their supplier:
“[insert name of wholesale distributor that received a direct purchase statement] received a direct purchase statement from the previous wholesale distributor.”
Then there is an interesting little section called “Clerical Errors and Other Discrepancies”, which has to do with what FDA expects companies to do if “clerical errors” are discovered in the transaction information they send or receive. I sometimes refer to “clerical errors” as “honest errors”. This draft guidance says that when these type of errors or other discrepancies are found in the transaction documentation, “…that trading partner should resolve the error or discrepancy as quickly as possible.”
“This may include immediately contacting the trading partner that provided the product tracing information to resolve the issue. If the error or discrepancy cannot be resolved and the product is determined to be a suspect or illegitimate product, trading partners must follow steps for verification of product, including, if applicable, quarantine and investigation.”
No guidance is given on what the FDA considers sufficient to “resolve the issue”. In my view, FDA could have been more clear here. Maybe you can tell them what you think is sufficient to resolve such issues in your response.
The final major section provides guidance on several special types of transactions where the DSCSA allows the seller to omit certain information in the transaction documentation. These include direct purchases (including subsequent transactions after the direct purchase), drop shipments to a dispenser and transactions involving grandfathered product.
This is the section that resembles the kind of information that the HDA attempted to explain in their “Supply Chain Product Transaction Scenarios” for the DSCSA (see “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”). But there are a few differences.
First, the FDA says that manufacturers must provide TH to a “subsequent purchaser”. I can’t tell if they are talking about every manufacturer sale, or only when the manufacturer buys drugs back from a wholesale distributor or dispenser, and then resells it to another wholesale distributor. The guidance isn’t clear. For the first sale, HDA indicates that drug manufacturers would not need to provide TH at all…because there wouldn’t be any prior history.
More importantly, this draft guidance is significantly different than HDA’s 2014 interpretation when it comes to sales by a wholesale distributor when the product was purchased from the manufacturer’s exclusive distributor or a repackager that purchases directly from the manufacturer. HDA believed that these sales by the wholesale distributor should be considered “direct purchases” and therefore would not require the exempted data elements afforded to those types of purchases. Exempted data elements include the full TH back to the manufacturer and the lot numbers in the TI. But the FDA’s draft guidance treats these as “subsequent purchases”, which means all of that data must be present in the wholesale distributor’s transaction documentation.
I was very skeptical of HDA’s interpretation back in 2014 (see “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”). In that essay I explained my interpretation and showed how it differed from HDA’s (then called HDMA). HDA will probably submit comments to the FDA that justifies their interpretation because this will likely be viewed as a hardship on their wholesale distributor members. We’ll have to wait until this guidance is finalized before we find out the FDA’s official opinion on it.
Finally, the draft guidance provides recommendations for handling product that is covered by the pre-2015 grandfathering sections of the DSCSA. Notice that this is not the same “grandfathering” that the industry has been discussing for the last year or so (for the current grandfathering discussion, see “FDA’s New DSCSA Grandfathering Guidance”).
Pre-2015 grandfathering has to do with product that was packaged prior to the original effective date of the DSCSA: January 1, 2015. Those products are not required to follow some of the provisions of the DSCSA and this guidance document provides better clarity regarding that. This includes how to handle the TH when the history extends back before the effective date, and TS when sellers cannot assert that the drugs comply with the DSCSA, since they were not required to.
To submit comments to the FDA about this draft guidance document before April 2, 2018, follow the instructions here.