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Four DSCSA Guidances Were Released this Summer: Are You Up to Date?

Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.

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At the HDA Distribution Management Conference, Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC, discussed four FDA DSCSA guidances that were issued on June 3, 2021. And as Pahl said about the following information, “this is the DSCSA advanced seminar.” Those looking for entry level information on DSCSA can click here.

(*The following are highlights from Pahl’s presentation; those looking for more information on the guidances can find it here.)

Identification of Suspect Product and Notification Final Guidance

This guidance provides updates, and finalizes the 2016 guidance, without many changes and should be familiar to most in the industry by this point. Said Pahl, “It provides very helpful information to trading partners on the suspect and illegitimate product systems and processes that you need to have in place in order to comply with section 582 of the act.”

Definitions of Suspect and Illegitimate Product

A revision to a previously issued draft guidance, this guidance updates definitions of suspect and illegitimate product. It updates definitions such as “stolen” to be product that's in your possession or control that you have reason to believe was stolen, or product that you have credible evidence that was stolen. Either of these would trigger suspect and illegitimate product obligations under section 582. Pahl said, “FDA gives examples of ‘stolen’ in the guidance, including product that's taken in a cargo warehouse or carrier theft. It also includes any packaging that's been stolen, and any product that's been removed or taken. An example of this would be a bottle of controlled substance where pills are taken out and replaced with acetaminophen. These would all trigger the suspect, illegitimate product requirements of section 582.”

The guidance also addresses a part of the definition of suspect and illegitimate product, which includes ‘unfit for distribution.’ Expired product, damaged product, and recalled product are not necessarily suspect or illegitimate, but they shouldn't be going to patients. Pahl said one helpful clarification is that product that's awaiting reverse distribution is not going to be considered unfit for distribution for purposes of suspect and illegitimate product obligations, under section 582.

Product Identifier Q and A Final Guidance

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