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  • jwgilbreath

DSCSA — Suspect and Illegitimate Products

Updated: Jun 3, 2023

Welcome back to the blog! Let's discuss one of the core reasons why DSCSA was formulated ...suspect and illegitimate products.

FDA has published guidance related to this subject as noted on the following link:

Let's hit the high points!

Suspect Product (per FDA) -- You have a reason to believe the product is potentially

•counterfeit, diverted, stolen

•subject of fraudulent transaction

•intentionally adulterated or appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans

So what are some red flags for suspect products? FDA has given some possible scenarios, which I have listed below, but you may also have some ideas as well!

--Missing label information

--Lot numbers or expiration dates do not match the outer/inner container

--Sometimes NDC’s might not

--Looks different than product on shelf

--No “Rx only” symbol

--Altered product info

--Missing or wrong package inserts

--Foreign language on label

--Damaged/broken seal/open package

--Bubbling on the label

--Different product name than FDA approved version

So, you've received something from a trading partner that has red flags. Now what?

  1. Quarantine the suspect product away from all other stock.

  2. Start the investigation in coordination with other trading partners

--Remember my previous post where I stated you must "verify" 3 products or 10% of the questionable products (whichever is the larger number). Verify per FDA means:

"Determining whether the product identifier (2D barcode) affixed to a package corresponds to the NDC serial number, lot number and expiration date assigned to the product by the manufacturer or repackager."

As an aside--remember most of your trading partners including wholesalers are not currently supplying all the information on the track and trace information noted on the 2d barcode. It is hoped by November 27, 2023 the information will be on the track and trace information as required.

Document your validation to show action taken as required.

--Contact the trading partner that you received the product from to question them regarding the item. They will let you know what information they have. More contacts may be necessary as well depending on the path of the investigation

Two possible outcomes of an investigation:

--Investigation has shown you do not have questionable items. You can remove the items from quarantine and start using the product.

--What if the investigation does show that the product is actually illegitimate? Now there is more to do!!

  1. Continue to keep product in quarantine.

  2. You have 24 hours (remember this time frame!!!!) to communicate with the FDA regarding the product. This is done electronically by using the FDA form 3911. Complete as much of the form as you can possibly complete. I would let the original trading partner know you entered the information as well.

  3. Await the FDA or the original trading partner to inform you how to handle the product.

An interesting aside---if your site is robbed and whole bottles of products are stolen there is a risk that those products will be placed back in the market illicitly. So, this requires you to ALSO complete a FDA form 3911 within 24 hours.

Also---from time to time, the FDA may send information to you stating to looking for a certain product that you must investigate. Remember that item must be quarantined. If what you have is illegitimate, complete the tasks as noted above. If not illegitimate (I.e., you don't have the product in question) it is ok to remove from quarantine.

So---What happens if you enter a 3911 and for some reason more information comes to your attention that lets you know the product is actually legitimate? Remember that product is still in quarantine! You cannot automatically start using the said product. You must compete another electronic FDA form 3911 to "request termination" of the previous FDA form 3911. You will need to include the original 3911 Form number on the new 3911. This does not automatically allow you to use the product. You MUST wait for the FDA to give you all clear before the item can be removed from quarantine for use.

I really cannot stress this enough...use a third party solution! The third party solutions such as LSPedia, Inmar RxTransparent, ConsortiEX, Advasur360, etc. have tools that you will find useful for validation, investigation, documentation of investigation, etc. The products can also be used to store investigation information as required for (you guessed it!!) 6 years.

If you choose not to use a tool, remember document all parts of the investigation and store that information for the 6 year time frame.

Hopefully you found this information useful. Please let your friends know about this blog. I want to start growing the group!

Thanks everybody!!!

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