Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.
A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that contains units from a single NDC and all units are from a single packaging lot. The product identification label should not be confused with a shipping/logistics label, which, if it exists, is applied at the time of shipment and contains information about the destination.
Typically, cases that are shipped from a higher-volume manufacturer to a larger wholesale distributor will be placed onto a pallet. The pallet often has cases of multiple products, and even different homogeneous cases of the same product can contain different lot numbers. You can sometimes even find a Non-homogeneous case mixed in with the homogeneous cases. Further, cases on the same pallet can actually be fulfilling different purchase orders submitted by the buyer. All of these variations complicate the job of the receiving clerk.
Fortunately, the Healthcare Distribution Management Association (HDMA) has published a clear guidance document to help standardize the various labels on products, cases and pallets. It’s called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain (2011)” and you can get a copy here. Keep in mind that this document, though still helpful, has not been updated to reflect considerations introduced by the passage of the U.S. Drug Supply Chain Security Act (DSCSA). It really should be updated, as you will see below, but it surprised me to learn recently that there are no firm plans to update the document this year. Too bad, but here are my thoughts on the impact of the DSCSA on the current practices related to case product identification labels and shipping labels.
BEFORE THE DSCSA
Before the DSCSA was enacted, cases were rarely serialized by the manufacturer. That is, for most products, neither the typical case product identification label nor the typical shipping/logistics label contained a serial number, unless perhaps one was applied for internal purposes by UPS, Federal Express or other courier. But a few manufacturers did apply an SSCC—which contains a serial number—to some of their shipping/logistics labels. Scheduled drugs were a likely candidate for an SSCC because the Drug Enforcement Administration (DEA) recommends not printing any kind of product identification on the outside of their shipping containers.
In the DEA’s Controlled Substances Security Manual, under the heading “Common or Contract Carriers” it says:
“Although not required, precautions such as securely wrapping and sealing packages containing controlled substances and using unmarked or coded boxes or shipping containers are strongly recommended for guarding against in-transit losses.”
It’s kind of hard to ship and “unmarked” box to a customer these days, but an SSCC is a nice way to keep track of which shipping case contains which product when it is referenced in an Electronic Data Interchange (EDI) Advance Ship Notice (ASN). That way, those who have access to the ASN will know what it inside, but others will not. The SSCC is composed of only a company identifier and a serial number that is unique to that company and that case.
Back in 2011, in preparation for the now preempted California Pedigree law, the HDMA updated their barcode guidance document. That document recommends the addition of a GS1 Serial Number (see “DSCSA ‘Serial Numbers’ “) to the barcodes they recommend on the product identification labels of homogeneous cases. See the section called “Homogenous Cases — Product Identification Labeling” on page 39 of the HDMA’s 2011 barcode document. This will result in what GS1 calls a “GTIN plus Serial Number”, or what a lot of other people call an “SGTIN” (for “Serialized Global Trade Item Number”) placed on the case at case-packing time.
When it comes to scheduled drugs, the HDMA document sort of punts. It simply says:
“Drug Enforcement Administration regulations must be followed when labeling scheduled drugs. This may differ from the recommendations below.”
“(controlled substances may or may not be identified for security reasons in accordance with the labeler’s policy and/or DEA regulations)”
The document provides no further guidance on labeling DEA scheduled drugs, but for all non-homogeneous cases of other drugs it encourages the use of an SSCC on the shipping/logistics label. See the section called “Individual Shipping Cases and Pallets — Logistics/Serial Shipping Container Code (SSCC) Label Format” on page 42.
The large wholesale distributors have included an SSCC on the shipping/logistics labels they apply, to varying degrees, for nearly 20 years. These labels are applied to totes and cases shipped to their customers. Their shipping/logistics label is slapped onto outgoing manufacturer’s cases regardless of what labeling the manufacturer applied. That is, even if the manufacturer had included an SGTIN on their product identification label, and/or an SSCC on their shipping/logistics label, the wholesaler applies their own unique SSCC when shipping a case to a customer—again, to varying degrees. Notice that this can lead to a single case with multiple serial numbers on it—up to 3 different serial numbers, in fact. Of course, before the DSCSA, serial numbers were not really used between companies in the supply chain so this did not cause a problem.
AFTER THE DSCSA…NOVEMBER 2017
The DSCSA contains new, specific language about how manufacturers must mark cases after November of 2017 (2018 for Repackagers). After those dates, all homogeneous cases packed by manufacturers and repackagers in the supply chain must have a DSCSA “Product Identifier” on them. After November of 2019 wholesale distributors may not buy or sell products that do not have a DSCSA Product Identifier on them, and the same goes for dispensers after November of 2020.
A DSCSA “Product Identifier” on a homogeneous case is the NDC and serial number (together known as a Standardized Numerical Identifier, see “FDA Aligns with GS1 SGTIN For SNDC”), the lot number and expiration date of the product contained inside. These data elements must be presented on the case in human readable form as well as in a 2-dimensional Datamatrix or linear barcode.
Congress made no provision in the DSCSA for the DEA’s recommendation to not mark the outside of cases containing controlled substances, so after these deadlines, companies who were previously using an SSCC to provide some level of concealment of the contents of their cases may be forced to expose those contents. To continue that practice, packing one or more properly marked homogeneous case(s) inside an overpack box marked with an SSCC is probably the best solution. But with this approach you might find that wholesale distributors expect you to provide accurate aggregation data (a.k.a., serial number-based packaging hierarchy data) in your ASN so they can tell exactly what is inside before they open the overpack box.
The DSCSA does not require the seller to provide the buyer with aggregation data until maybe (probably) November of 2023 (see “When Will The DSCSA Ever Require Investments In Aggregation?”). But once every homogeneous case is serialized, wholesale distributors may feel justified in asking manufacturers and repackagers to provide them with aggregation data at the shipping container level. Technically, container-level packaging hierarchy is already being supplied by any company following HDMA’s EDI ASN guidance (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”), but that packaging hierarchy is provided without serial numbers today. It may be logical for wholesale distributors to expect manufacturers and repackagers to include the serial numbers of each shipping container in their ASNs once every shipping container is serialized. This could be an “intermediate” aggregation state that companies could use as a stepping stone toward full unit-level aggregation data collection.
I think the current situation where some homogenous cases can end up reaching a hospital or pharmacy with up to 3 different serial numbers on them will become more of a problem as these dispensers begin to deploy systems aimed at meeting their requirements under the DSCSA. At some point, these companies will begin to scan the serial number barcode as part of their receiving processes. When they do that, they had better find only a single serial number on each homogeneous case, and it had better be the DSCSA-mandated “product identifier” that the manufacturer or repackager applied, not an SSCC that the manufacturer or wholesale distributor applies today. Companies routinely applying an SSCC to homogeneous cases today need to figure out a new way of meeting their needs after 2017/2018.
THE JOB SEARCH
Only a few days have passed since I notified you that I am looking for a fulltime job (see “The Future Of RxTrace”). Not much has changed over that short time so there is nothing new to report, but I would like to acknowledge the many public and private messages I have received from RxTrace readers wishing me well. Thank you all for your continued support and your kind words.