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  • jwgilbreath

Verification Systems —DSCSA

Updated: Jan 14

I know it's been a while since my last post...the holidays plus traveling a lot for work!


So, the FDA did puboish new guidance in December related to "Verification Systems."


Here is the link (you may need to copy and paste it).


A snippet from the guidance is this:


"Trading partners must verify suspect product (sections 582(b)(4)(A)(i)(II), (c)(4)(A)(i)(II), (d)(4)(A)(i)(II), and (e)(4)(A)(i)(II)). This includes determining whether the product identifier affixed to, or imprinted upon, the package or homogeneous case of product corresponds to the information assigned by the manufacturer or repackager. The product identifier includes the standardized numerical identifier (SNI), lot number and expiration date of the product. The SNI includes the products National Drug Code (NDC) and serial number. See sections 581(14), (20), and (28) of the FD&C Act for the definitions of product identifier, standardized numerical identifier, and verify."


Notice the verification process is to the manufacturer or repackager level.


For dispensers the following is noted in the guidance:


"The product identifier must be verified for at least 3 packages or 10 percent of such suspect product, whichever is greater, or all packages if there are fewer than 3. Therefore, the verification requirement for dispensers differs from that of other trading partners when there are more than three packages of suspect product. In addition, dispensers have the additional requirement to verify the product identifier by confirming that the lot number corresponds with the lot number assigned to the product by the respective manufacturer or repackager. To do this, a dispenser may consult the transaction information and transaction history to verify the product lot number and if the dispenser is not able to verify the product lot number (e.g., neither the transaction information or transaction history contains the required information) the dispenser should contact the manufacturer or repackager of the product."


Notice you must verify (i.e., verify the product identifier information noted above) the specified quantities at minimum of 3 items or 10% whichever is greater. Also, pay attention to the extra information required for dispensers related to Lot Number. When performing a full verification lot number evaluation should ALWAYS be a part of the evaluation. Theoretically, you can match the lot to the transaction information noted from the supplier authorized trading partner. If not possible you must contact the manufacturer or repackager. Personally, for completeness sake I think for investigating suspect products you need to contact the manufacturer in all cases to complete the verification process and match the Lot Number. This will help open the lines of communication with those trading partner..remember... if the suspect product is actually illegitimate you are required to let them know anyway as well as the FDA.


These are just my thoughts. If you want to interpret differently that is your prerogative as I am not legal counsel. Personally, I attempt to go above and beyond in investigations because systems problems may be present that I can identify.


Start testing your processes for verification! This is even noted in the document! Keep pushing forward! Remember we are still in the stabilization period BUT the FDA expects you still to be moving forward and test your procssses. Make sure your employees understand the DSCSA processes!


Using a third-party DSCSA compliance solution may help you with verification processes too!

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