Hello all!
I know I have been bombarding you with info regarding DSCSA last few days! I attended a Seminar that was solely discussing DSCSA and it's impacts to industry. Most of the focus was on manufacturers and wholesalers/3POs ... BUT... what affects them will roll down and affect you as well. There was also some discussion directly tied to how the pharmacy will be affected as well.
As you hopefully noted my previous emails about the FDAs allowing for a year for a "stabilization period." Hopefully, you noted my comments that this allowance is NOT an allowance to stop moving forward with your DSCSA processes.
That guidance discussed the idea of the "stabilization period."
So, another guidance document has been published by the FDA that does impact your process planning and execution titled:
"Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Guidance for Industry"
The link to this guidance is as follows:
One point in this document I wished to discuss with you has to do with reconciliation. The wording they use for the receiver such as your pharmacy is called to "confirm" the information. I used the term reconcile because that is what you are doing...you are reconciling the products you receive vs. the transaction data you have. The purpose of this reconciliation is to ensure that your data is good. I realize this is a nebulous thought. FDA does NOT define how to complete this process. They just state that is SHOULD be done. I also realize the term SHOULD is not as definite as "must." With this being said, I would hope that you are doing what you can to ensure you have good data. Of course, baseline is to ensure that all items are received correctly as per ordered. If extra, less, or wrong items are in your delivery, contact your wholesaler. That is bare minimum of reconciling. Extra checks would be to ensure the 2D barcode data matches the shipped items. How you accomplish this is based on your facilities practices. If you are using a third-party solution, scanning the products when full "go live" of EPCIS feeds from you supplying trading partner will be an automated process to handle this. I personally think this is the best practice you should use. If not using a third-party service or if they don't have scanning capability, you will need to use your transaction information in your wholesalers Web Portal to compare the info. Personally, I would print off the info and mark off that you checked it showing action of a reconciliation. Now the hard part...how many of the items are you going to check? 100%? 50%? This is in no way defined by the FDA but I do expect they would like to see some process regarding this if they were to visit. You need your process in procedures/SOPs and ensure the process is being done. Personally I would want to see 100% check.
If errors/exceptions are found, quarantine the product and communicate with your supplying wholesaler. If it appears to be suspect, further investigation may be needed.
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