A “product grouping” is any collection of saleable units of products that are bound together in some way. They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these. The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not. I’ll try to catalog what we know about product groupings in each of the current, known regulations.
THE UNITED STATES
The United States is pretty easy because I have already written about some of the issues related to product groupings under the DSCSA (see “ANVISA And The SSCC Controversy”). The title of that essay makes it sound like it is only about Brazil’s old law (that law was recently replaced by a new law [see “Brazil Gets Rational With Their New Pharma Traceability Law”]), but near the end, it also discusses some important characteristics of the DSCSA as it relates to serializing homogeneous cases. In that essay I talk about how some cases will probably end up with multiple serial numbers on them. The DSCSA mandates a linear or Datamatrix barcode on each homogeneous case that encodes the SNI (NDC+serial number), the lot number and expiration date.
What happens if you build your homogeneous cases with a group of “bundles”, which themselves are homogeneous groupings of the saleable units that are shrink-wrapped together? This technique is growing in popularity among manufacturers of drug products aimed at the U.S. market, and others, because it makes the case-packing process easier and serialization data collection more accurate. But be aware that the DSCSA does NOT require these bundles to be serialized or even labeled. On the other hand, nothing prevents you from doing so if it helps you. As far as I know, some companies are labeling and serializing bundles and some are not. Either way is probably fine, as long as you have some way of capturing the aggregation data at the case-level for the big wholesale distributors. I don’t think those companies are going to care whether or not you label and serialize these bundles, but they would probably appreciate being asked.
The DSCSA does not mention anything about non-homogeneous cases. A case that is not homogeneous could be a non-standard grouping count, have more than one lot number present or contain more than one NDC. You may still want to serialize these cases and include them in your aggregation data. If you do, DO NOT use a GTIN+serial number combination. Use the GS1 Serial Shipping Container Code (SSCC) instead. See my explanation in “ANVISA And The SSCC Controversy”. In fact, use the SSCC for any other grouping at all.
In the United States, manufacturers will not have any need to put a GTIN+serial number, AND an SSCC on homogeneous cases, so when the first wholesale distributor receives them, they should contain only one serial number. However, anyone else might end up adding a second serial number to homogeneous cases that do not get opened. That’s because the large wholesale distributors currently add an SSCC to everything that goes out their doors (OK, one of the “big-3” might not put it on everything, but even they put it on many things going out their doors). Whenever someone downstream receives these homogeneous cases after November 2023, they should also receive aggregation data from the wholesaler, and that aggregation data should include the same aggregation data provided to them by the drug manufacturer, including their original GTIN+serial number, PLUS an extra aggregation layer that links their own SSCC to that original GTIN+serial number. That SSCC is usable to find the unit-level contents of any given homogeneous case, but it is not suitable for DSCSA verification during a suspect product or saleable returns investigation because the drug manufacturer will not know about it. According to the DSCSA definition of “verification”, only the drug manufacturer (or repackager) can verify a drug. Those investigations must only use the original manufacturer’s GTIN+serial number (technically the NDC+serial number) for verification. So there will be some extra complexity that results from that existing practice, assuming it continues.
One more thing about the use of SSCC in the United States. Outside the DSCSA, the Drug Enforcement Administration recommends that drug manufacturers and others in the supply chain refrain from identifying the contents of a shipping container that contains Class II drugs. Consequently, if those shipping containers are going to be serialized, they should only make use of an SSCC. A GTIN+serial number would identify the contents. How this recommendation fits with the FDA’s enforcement of the DSCSA is anyone’s guess but it seems like the DEA recommendation should take precedence, leading to the use of SSCC to serialize product groupings of Class II drugs that also serve as shipping containers. (I’d give you the URL for the DEA’s recommendation but their diversion control website is not responding from Italy this morning.)
My essay “ANVISA And The SSCC Controversy”, discussed another complication that would have resulted from an odd and unfortunate requirement in RDC-54/2013, the old ANVISA serialization regulations. That was the requirement that all “transport packages” must have an SSCC on them (see that essay for a full explanation of the old problem). I don’t think we can know yet if that requirement will exist in the new regulations because the old regulations are gone and the new regulations have not yet been enacted (see “Brazil Gets Rational With Their New Pharma Traceability Law“). As soon as we get a new draft or enacted regulation I will write about the entire thing in one or more RxTrace essays, including whether or not that problem will exist going forward.
THE EUROPEAN UNION
The Falsified Medicines Directive is an authentication-at-the-point-of-dispense law, which is designed to minimize the amount of data that is passed forward in the supply chain. For that reason, neither it, nor the companion Delegated Regulation (EUDR) mandate anything about serializing cases, whether homogeneous or not. I suspect the authors are quite proud of that. However, the law does require everyone in the supply chain to decommission unit-level unique identifiers (see “Decommissioning Under the FMD/EUDR”). Under some situations, including exporting drugs outside the E.U., cargo theft, destruction and, under certain conditions, during shipping from a wholesale distributor and/or anytime after receiving at a large dispenser, this decommissioning requirement will be very inefficient unless each case is serialized and accurate aggregation data is available. If aggregation data is “voluntarily” produced by the manufacturer it would require the manufacturer to put a serial number on every case. Why am I skeptical that that will happen?
IN SOUTH KOREA
It is hard to tell for sure if South Korea requires drug companies to collect aggregation data or not, but they talk about it being done at least for “convenience during warehousing, release”, in a Department of Health and Welfare document I have seen. Unfortunately I cannot find it on the open internet so I cannot provide you with a link. If you ship drugs to South Korea, I’m sure you already have that document. It appears that drug manufacturers should serialize their logistics units with a GTIN+serial number if the container is homogeneous. Use an SSCC when it isn’t. I think this will result in only one serial number per shipping container so aggregation should be straight-forward. But it also appears that the use of an SSCC leads to the requirement to supply aggregation data so that downstream trading partners are able to look up the contents of the container without breaking the seal.
My interpretation of the South Korea regulation could be very weak so make sure you get a second opinion.
Saudi Arabia does not yet require aggregation or serialization of product groupings or shipping containers. It appears they will require it someday in the future. How far into the future? They aren’t saying yet. Stay tuned.
Exports from India fall under the Directorate General of Foreign Trade (DGFT) serialization requirements. In my observation, the DGFT has never put in the amount of study and time necessary to come up with a logical regulation, and only recently has come up with what appears to be a workable timeline (see “India’s Pharma Export Regulations Update And The NECC Story”, “India’s Pharma Export Serialization Deadlines: April Fools!”, and “India Posts New Deadlines (Again) For Serialization Of Drug Exports”). A Public Notice from the DGFT provides some additional details last year around their original pharma export serialization regulation. It seems to say that the tertiary level (logistics units) should be serialized with a GTIN, lot number, expiration date, and a serial number provided by an SSCC. At least it includes only one serial number, but it does not say what to do if there are more than one GTIN in the container. Hopefully that won’t happen very often. The collection of aggregation data based on those SSCCs and upload to the DAVA portal is required today for larger companies, and will be required after the end of March this year for smaller companies.
I don’t mention Turkey and their serialization and tracing regulation very often because it has been operating for quite a while now. They mandate the application of an SSCC to all transport units and the collection of aggregation data for reporting to the government.
The SSCC is a simple way to add a serial number to a shipping container and/or product grouping that allows you to avoid specifying a distinct GTIN. There are logical times when you would want or need to do that. Regulations that demand the use of SSCC on all shipping containers, or block its use, lead to unfortunate situations, as we see above.