Scenario 6 - Suspect and Illegitimate Product Determination, Notification and Termination Processes

Warehouse Lead

1. Closely examine the package and the transport container (such as the case or tote):

· Look for signs that it has been compromised (e.g., opened, broken seal, damaged, repaired, or otherwise altered). 

· If the product is in a secured transport container or sealed homogenous case, examine the appearance of that container to see if anything about that appearance seems suspicious, such as shrink wrap that has unexpected markings, or a seal that is broken, torn, or repaired.

· Check to see if the package or the transport container has changed since the last shipment of the same product type was received for an unexplained reason (e.g., a notification about the change from the manufacturer has not been received). 

· Check to see if product inserts are missing, do not correspond to the product, or are suspicious in some way. 

· Inspect the shipping addresses, postmarks, or other materials indicating that the product came from an unexpected foreign entity or source. 

2.  Closely examine the label on the package, and the label on the individual retail unit, if applicable, for: 

· Any missing information, such as the lot number or other lot identification, NDC, or strength of the drug. 

· Any altered product information, such as smudged print or print that is very difficult to read.

· Misspelled words.

· Bubbling in the surface of a label. 

· Lack of an “Rx only” symbol. 

· Foreign language with little or no English provided.

· Foreign language that is used to describe the lot number.

· A product name that differs from the name that appears on the FDA-approved drug label or labeling.

· A product name that is the product name for a foreign version of the drug.

· A product that is transported by a case or tote, when not expected under the circumstances.

· Lot numbers and expiration date on the product that do not match the lot numbers and expiration date of its outer container.

QA Lead

3. Inspects product per SOP ______, Product Receipt, Quarantine, Inspection and Disposition

QA Lead

1. Dispositions the product following <SOP #>,  <SOP name>.

QA Lead

1. Upon trading partner determination of a suspect product, <company> will coordinate an investigation with the trade partner along with validation of the TH and TI contained on the ASN and further inspection of the returned product.

2. If product is confirmed illegitimate, proceed to step 6.6.4 below.

3. If the product is found to be legitimate, the customer is notified and <company> follows current business practices.

Warehouse Lead

4. Quarantines the material per <SOP #>, <SOP name> for further physical examination by <company> or FDA.

Regulatory Affairs (RA)

1. Assist with, in conjunction with the trading partner, any disposition/deviation/notification with the product.

2. Within 24 hours after determining, or being notified by FDA, or by a trading partner that:

· There is a high risk that a product that the manufacturer has reason to believe is in an immediate trading partner’s possession is an illegitimate product; and/or

· There is a specific high risk that could increase the likelihood that illegitimate product will enter the U.S. pharmaceutical distribution supply chain; and/or

· There exists an “other high risk” as determined by FDA in guidance pursuant to subsection 582(h).

Access form 3911 at the link below and follow instructions on the Web page.

http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm 

3. Initiate recall activities per <SOP #> <SOP Name> if necessary.

Regulatory Affairs (RA)

1. When necessary, access FDA’s Web page for the Termination of Notifications form 3911 at

 http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm 

2. Follow the instructions on the Web page for accessing Form FDA 3911 (Appendix 1). Using this form provide to FDA the following information:

2.1.1 the person or entity initiating the request for termination

2.1.2 the illegitimate product or the product with a high risk of illegitimacy

2.1.3 the notification that was issued, and an explanation about what actions have taken place or 

2.1.4 what information has become available that makes the notification no longer necessary. 

2.1.5 Include the FDA-assigned incident number associated with the notification in the request for termination. 

3. The form must be submitted by using the method provided in the form or on the Web page. The submission of a request for termination of a notification will be viewed as a request for consultation with FDA, as required in section 582 of the FD&C Act. FDA may request any additional information it determines necessary to complete the consultation.

4. Be available if the FDA has any questions while reviewing the termination of notification. 

NOTE:  The response time will depend on the number of requests for termination and the circumstances surrounding the requests for termination that are received by FDA. 

Supply Chain Lead

5. Notifies the trading partner per the FDA’s response to the Termination Notification(s).