The California pedigree law requires manufacturers to serialize the smallest package of drugs that will be bought by a dispenser. For some manufacturers targeting the U.S. market, that may require serialization and e-pedigree at a lower unit of measure than they might have thought. For products that manufacturers package into multi-packs and sell to wholesalers packaged only that way, you might assume that your “smallest package or immediate container” is the multi-pack. Think again.
For pharmaceutical manufacturers with products in this category that are distributed in California, I strongly suggest that you poll your wholesaler customers and find out how often they break down your multi-pack today and sell the individual packages inside to their dispensing customers.
The exact wording of the California law regarding this is as follows:
A pedigree shall track each dangerous drug at the smallest package or immediate container distributed by the manufacturer, received and distributed by the wholesaler or repackager, and received by the pharmacy or another person furnishing, administering, or dispensing the dangerous drug. For purposes of this section, the “smallest package or immediate container” of a dangerous drug shall include any dangerous drug package or container made available to a repackager, wholesaler, pharmacy, or other entity for repackaging or redistribution, as well as the smallest unit made by the manufacturer for sale to the pharmacy or other person furnishing, administering, or dispensing the drug. [California Business and Professions Code, §4034 (d)]
Yes, you could probably say that your multi-pack–just like today–is the level of packaging that you will make available for sale to your immediate customers and so that’s all you will be required to serialize and pedigree. And theoretically, that’s probably true. But, if today, wholesalers routinely break your multi-pack down further as part of their friendly service to their customers, they won’t be able to do that once they begin operating under the California pedigree law.
That’s because the pedigree that you will provide to them at that time cannot be subdivided any further than your multi-pack since the units inside of the multi-pack will not be serialized and not pedigreed. Once the law goes into effect in California for wholesalers they won’t be able to have non-serialized and non-pedigreed partial packages of drugs sitting on their shelves.
How will that impact your business? Will the pharmacies in California simply start buying your multi-pack, since that’s all that is available to them, or will their wholesaler help them find some alternative drug that is serialized at a lower unit of measure instead? Will wholesalers outside of the state of California where serialization and e-pedigree are not required be willing to break the multi-pack down as they do today? Poll your customers, and their customers, to find out before you establish your final serialization and pedigree plan.
When you are ready to serialize the individual packages contained inside your multi-packs, make sure you consult the GS1 Healthcare GTIN Allocation Rules to get the GTINs right. Then consult my essay “Anatomy Of An FDA SNI” to learn how to combine a GTIN with a serial number to serialize them.
Dirk.
A question may be whether the manufacturer is responsible for someone in the supply chain who decides to open the manufacturer’s sellable unit and sell its components.
The manufacturer is complying with the law when they provide a California compliant e-pedigree for the product as they sell it.
Repackagers or those who break down the item to dispensing units may be limited in California because the repackaging may not comply with the manufacturers wishes and the manufacturer may not feel obligated to serialize to support someone in the supply chain selling the product in a way the brand owner did not condone.
Hi Dirk, for once I don’t see the logic of your argument.
The quoted CA text states unambiguously that serialization ends with what’s delivered/sold to the pharmacy as saleable unit, and not to what the pharmacy gives to the patient as saleable unit. The traceability contemplated by the legislation ends, practically, at receiving by the pharmacist.
So of course the individual vial or a tablet torn from a blister pack after ownership is taken by the pharmacist is not traceable to a serial number. And counterfeits could even enter the supply chain after receiving by the pharmacy, especially when we’re thinking of the large chains that have their own warehouses. But again, the ruling doesn’t extend into the pharmacy beyond the receiving bay (or receiving hatch!).
So why do you believe that manufacturers need to think of serialization to a lower level than what their wholesaler will sell?
Stephen,
I think I see the problem. I am addressing a practice that occurs in the U.S. supply chain where the term “multi-pack” has a different meaning than it does outside the U.S. Sorry for the confusion. We are in agreement. I am saying that manufacturers of drugs sold into the U.S. market as multi-packs should pay attention to what the wholesaler may be doing with that product when they sell it to a pharmacy. If today they are routinely breaking that multi-pack down, then the manufacturer should think about how it will impact their business when the wholesaler can no longer do that breakdown under the California law. I am not talking about what the pharmacy does. Sorry for the lack of clarity this time. I will add the phrase “in the United States” in the essay to narrow my point.
Thanks,
Dirk.
OK Dirk, thanks for the clarification.