The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers). These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).
A common question is, what is the smallest level of packaging that must be serialized?. The DSCSA text provides the answer.
This is an update to an essay I wrote back in 2013 about the same topic, but for the California pedigree law (see “InBrief: ‘The Smallest Package Or Immediate Container’ In California“), which was subsequently preempted by the DSCSA. The California pedigree law would have required manufacturers to serialize the smallest package of drugs that will be bought by a dispenser. The DSCSA is basically the same. For some manufacturers targeting the U.S. market, that may require serialization 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 individual saleable unit” is the multi-pack. Think again.
For pharmaceutical manufacturers with products in this category, 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 DSCSA defines the term “Package” this way:
“(A) IN GENERAL.—The term ‘package’ means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product.
“(B) INDIVIDUAL SALEABLE UNIT.—For purposes of this paragraph, an ‘individual saleable unit’ is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser. [DSCSA Section 581(11)]
Yes, you could probably say that your multi-pack–just like today–is the level of packaging that you intend for ultimate sale to the dispenser and so that’s all you will be required to serialize. And theoretically, you would be right. But, if today, before serialization is required, 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 serialization requirements of the DSCSA–November 27, 2019.
After that date they will no longer be able to break any package down unless the components within are also serialized by the manufacturer or repackager.
“So what?” you say? If your product is routinely broken down by the wholesaler today, that is done to supply small pharmacies with a smaller amount of your product so they are able to dispense it before the expiration date. This has happened in the past with multi-packs of some prefilled insulin syringes, some vials and similar products.
Admittedly, not many products fall into this category, but if yours is one that does, you should think about what those small pharmacies might do if they will be forced to only buy your product in the full multi-pack. Will the pharmacies decide to start buying your multi-pack, since that’s the only form available to them? Or will their wholesaler help them find some alternative drug that is serialized at a lower unit of measure instead? Poll your customers, and their customers, to find out before you establish your final serialization 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.