Meeting+Minutes+May+28+2009+ER&DL+Workgroup

1. Meeting mintues for May 28th
//Mostly update from Face to face meeting//


 * __Update from FDA FACE TO FACE Meeting__**

Kits include more than one product.  Each part of the kit must be identified. The //entire// kit must be identified.  The //kit// product code //cannot// match any //part// of the kit as this will result in validation issues. The Dosage Form is kit.
 * The validation checker for labeler code request and Establishment requests will be turned off for the time being to allow companies to submit SPL r4 files. They will be turned back on at some point without warning. But this can be a way to get in several drug listing files that companies are having difficulty getting information from third parties.
 * If you do not have all of your establishment DUNS numbers, FDA is requesting that you include the ones you do have and leave off the ones that you don't. This also goes for inactives where you do not have all the UNII codes.
 * Also, there was an update to the validator to reflect changes in the Validation procedures. This just occurred on the 18th. If you are not familiar with the validator, here is a link: [|[[http://www.fda.gov/oc/datacouncil/validate.html]]]
 * FDA has also agreed to include the DRLS group from FDA at the June 10th meeting. Individuals from DailyMed will also be present to discuss project PillBox. This is the high resolution image of final solid oral dosage Rx products that will be included in the SPL file.
 * Repackager/Relabelers should use  Source NDC should be used when the manufacturer is not known. 1 source NDC per product.  Multiple NDC numbers will result in multiple product listing tables.
 * Future SPL contacts** in regards to the SPL files will be sent directly to the eGateway mailbox of the person that submitted the files to the OC. The messages should be received within 24 hrs of submission if there are issues with the file
 * Future SPL contacts** in regards to the SPL files will be sent directly to the eGateway mailbox of the person that submitted the files to the OC. The messages should be received within 24 hrs of submission if there are issues with the file


 * 2. Next meeting Scheduled for June 11, 2009 at 2 pm EST - Please not change in time:**