Next November, DSCSA will require pharmacies to verify and record product identification information at the package level for most prescription drugs.
You’ve probably heard about upcoming changes to the Drug Supply Chain Security Act (DSCSA). Pharmacies will now be responsible for enhanced security provisions for drug distribution starting next year.
For a busy pharmacy professional, “next year” may feel like the far future and then appear like it’s next week. It’s always best to be prepared. With these DSCSA updates pharmacies have greater responsibility (and by extension more potential liability).
If you’re unsure what these DSCSA updates mean for your pharmacy or where to begin, here is some guidance for finding the best tools for your pharmacy. Keep in mind, regulators and government criteria seem to keep evolving, and we’ll continue writing and publishing information as it comes out to keep our readers informed.
Enhanced Drug Security Requirements for Pharmacies
Effective November 27, 2023, pharmacies will be required to verify product identifier information at the package level for most prescription drugs in finished form when they’re involved in a transfer of ownership. There are exceptions to this; such as, 503b compounded medications and inventory transfers based on pharmacy acquisitions.
The relevant product identifiers include the NDC, serial number, lot number and expiration date. In addition to product identifiers, pharmacies must also track information about the transfer of ownership. Many pharmacists abbreviate this information as “T3” data because it includes three transaction pieces: history, information, and a transaction statement. All of this information is captured at the saleable unit level: the bottle, box, packet, or any “smallest individual saleable unit.”
The new regulation also requires “systems and processes for verification of product at the package level…to promptly respond…in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product.” Pharmacies must not only check the data; they have to record it and be able to produce it on demand.
The law initially required only manufacturers to verify products based on product identifiers. That’s why packages have a unique serial number along with (as of 2018) a 2D barcode capturing the identifier information. Over the years, repackagers, wholesalers, and dispensers were added to the law. Now, this “enhanced product tracing” includes pharmacies. Read more >
