The upcoming changes will be less disruptive but will have far-reaching consequences throughout the pharmaceutical supply chain.
The final part of the Drug Supply Chain Security Act (DSCSA) will take effect on November 27, 2023. When it began in 2013, the massive serialization efforts it triggered were a major distraction for the pharmaceutical industry. The upcoming changes will be less disruptive but will have far-reaching consequences throughout the pharmaceutical supply chain. Already, the changes it will bring for warehousemen and shippers are causing technology providers to rethink some of their systems to accommodate the new requirements without disrupting clients’ businesses.
At a recent U.S. Food and Drug Administration event, Abha Kundi, regulatory counsel for the FDA’s division of supply chain integrity, and Connie Jung, R.Ph., Ph.D., senior advisor for policy at the Center for Drug Evaluation and Research (CDER), pointed to two notable changes.
First, all information regarding product and shipment throughout the supply chain must be conducted electronically. Second, additional information must be added to the label at the individual product level.
Specifically, after Section 582(g) Enhanced Drug Distribution Security (known as the enhanced system) is implemented in 2023, transaction information must still meet today’s standards, but also must include the product’s:
- National Drug Code number
- Lot number
- Serial number
- Expiration date
In addition, secure, interoperable, electronic tracing of products at the package level must be in effect. At a systems level, this requires:
- Exchanging transaction information, including the product identifier and standardized numerical identifier, at the package level
- The ability to respond with the transaction information and transaction statement for products upon request, in the event of recalls or investigations of suspect or illegitimate product
- The information for each transaction to be traceable to the manufacturer
- The ability to support acceptance of saleable returns when they can be associated with the transaction information and transaction statement
The details listed in Section 582(g) Enhanced Drug Distribution Security of the Food, Drug & Cosmetic Act, and guidances, regulations and pilot programs will be posted on the FDA’s DSCSA site.
The biggest challenge for shippers, particularly at the wholesale level, may well be reading carton or product information from deep inside aggregated shipments. As John Wirthlin, industry principal for manufacturing, transportation and logistics at Zebra Technologies told BioSpace, Radio-frequency Identification (RFID) traditionally hasn’t penetrated the packaging. It has been highly effective in automatically reading pallet-level information as it passes through warehouse portals, but reading carton-level tags from deep within those pallets has not been feasible. As a result, aggregated pallets had to be unpacked and scanned, or their data inferred from shipping documents.
Zebra found a way around this, using existing technology to penetrate the air gaps within the packaging that allows carton-level tags to be read with a high degree of accuracy. Zebra will be formally launching these solutions around the end of this year. Basically, this solution combines RIFD and barcode technology into one tag so the RFID chip and barcode contain the same information. RFID-tagged cartons with hard-to-read products can be read quickly and accurately regardless of where they are positioned in a pallet.
“We tested five pallets of products – dry tablets, liquid vials, prefilled syringes, foil blister packs and high viscosity liquids. The pallets were run through RFID portals at a dock door at usual forklift speeds,” Wirthlin said. “All product was read at 100% accuracy, with the exception of 840 sixteen-ounce bottles of high viscosity liquids on the pallet that were read at 75% accuracy.”
The technology can be implemented in a few different ways. Most simply, “we can put RFID devices at different workflow locations (such as pallet build, pallet wrap and tunnels). Source tagging at the manufacturer’s packing line is key. Zebra‘s ZE 511 print engine can be used to upgrade existing print-and-apply systems so users can encode the inlay (the RFID data) along with the existing carton label and barcode,” Wirthlin said. RFID readers are self-contained and simply require Power Over Ethernet (PoE) connections and floor bolts to deploy the solution.
“We also can put a device on a pallet wrapper. To reach heavy liquids, we can build a four-sided tunnel that saturates the read zone,” he added.
Zebra is discussing enhanced RAIN RIFD technology with pharma executives now, and at its booth at the LogiPharm logistics and supply chain conference, October 19-20.
Such improved RFID capabilities further automate shipping and receiving operations and thus improve both speed and accuracy since the data becomes centralized, populating warehouse or transportation management systems.
When manufacturers, shippers, and distributors can access the information from a centralized, trusted source with the data stored in the cloud, data can be managed with near-perfect accuracy.
The serialization efforts that began in 2013 have tightened the supply chain and made counterfeiting more difficult, but counterfeit products are still entering the supply chain and finding their way to patients, Kundi said. For example, in August 2021, Gilead Sciences discovered counterfeit HIV medications that were being distributed in genuine Gilead bottles. In 2020, Janssen had a similar experience with counterfeit Symtuza®. In both cases, the products had been purchased by pharmacies from unauthorized distributors.
The enhanced requirements that take effect in 2023 aim to prevent such occurrences by requiring entities to conduct business only with authorized trading partners. That means partners who meet the requirements outlined in the DSCSA for electronic data. As Peter Sturtevant, senior director of community engagement at GS1 in the United States, told BioPharm in July, “some companies are still using fax machines…” So, this will have a major impact.
