The company has been working since 2015 to implement the track and trace elements required by the Drug Supply Chain Security Act.
Pharmacy owners and employees are, by now, familiar with DSCSA, the Drug Supply Chain Security Act. Enacted by congress on November 27, 2013, DSCSA first became effective in 2015, explained Scott Mooney, vice president of distribution operations at McKesson, during his session on navigating DSCSA at McKesson ideaShare 2023,1 with “rudimentary traceability.” But on November 27, 2023—10 years after becoming law—DSCSA poised to become a very real issue that pharmacists must face.
“The DSCSA’s purpose is to secure the US supply chain and to make sure that we have the ability to detect counterfeit products when they’re introduced to the supply chain,” said Mooney. DSCSA is also intended “to trace legitimate products from the manufacturer down to the dispenser—or the opposite, from the dispenser back to the manufacturer.” Through this track and trace oversight, products, transactions, and stakeholders are linked throughout the supply chain at the individual product level.
“If you take nothing else away from this conversation today, please understand that the State Boards of Pharmacy and the FDA are both chartered to be able to enforce the DSCSA,” he said. “They will likely be showing up in your pharmacies from time to time as part of their regular inspections or audits, and in that process, they will be asking you about your DSCSA data.
McKesson customers have been primed for the DSCSA changes since 2015, when the company began implementing lot-based traceability. By 2019, package labeling changed to include a 2D matrix barcode—reminiscent of a QR code—in addition to the standard linear barcodes, in which the product’s NDC number is encoded. Also encoded for the first time were digital representations of the product’s lot number and expiration dates, as well as a serial number—"a new value,” according to Mooney.
“Every product package in the United States has a unique serial number on each individual package,” he explained. “There may be 10,000 bottles in a lot, but those 10,000 bottles are all individually numbered.”
DSCSA implementation also means that wholesalers such as McKesson are now required to track serialized bottles across the entire supply chain. When a wholesaler purchases a product from a manufacturer, that manufacturer will supply the individual serial numbers of each product sold. A pallet with 48 cases will have 48 serial numbers; each of the products within those 48 cases will also have their own serial numbers, increasing the visibility of products on the individual level.
So what do pharmacy owners need to do to prepare? Perhaps most important is staying alert for illegitimate products, and knowing how to conduct investigations if illegitimate products are received.
“You need to have a policy and a standard operating procedure [SOP] in your pharmacy to be able to detect suspect or illegitimate products should they happen to come into your pharmacy,” Mooney explained. McKesson also has procedures in place to help ensure the security of the supply chain. “But,” he added, “you still have to have the ability to look at a product that’s coming in to your pharmacy and identify if there’s something wrong with it.”
These issues can be as small as expecting a white cap on a bottle, but receiving a green cap instead, examining a product to ensure it hasn’t been opened and replaced with something else, or receiving a product with a label in a foreign language—perhaps indicating that the product was brought into the United States from a foreign market.
This is where a pharmacy’s suspect product process comes into play: regulators may ask the pharmacist what steps they followed to address their suspicions, and pharmacists must be able to demonstrate that they followed their SOP to the letter. “If your SOP says, ‘I’m going to put that product on the corner shelf and hold it there until I’m done completing my investigation,’ make sure that you can demonstrate to regulators that you put your product on that corner shelf where it’s supposed to go,” Mooney said.
Over the last decade, McKesson has been working to prepare customers for the implementation of DSCSA, including collecting Global Location Number information and capturing serialized product identifiers to create DSCSA datasets for customers.
“In McKesson Connect, which is one of the options you have for managing your data, you will be able to you will be able to log in and access the serialized data, and you can query…’What product did I buy today?’ because you want to check off that you accessed your DSCSA data,” Mooney said. Crucially, McKesson Connect will retain, and provide access to, that data for the entire 6-year record retention period now required by law. For customers who buy across McKesson business units, all transaction data will become available in one spot beginning November 27.
“There’s a lot McKesson can do to help you with this lift. We will capture the data, we will provide that data to you…We can assist you when you need to do an investigation,” he said, adding that McKesson is committed to staying engaged with industry stakeholders as the DSCSA deadline draws near.