Meeting+Minutes+Apr-15-09+DL&ER+Workgroup


 * 1. Export Only Products:**

Discussions continued again around Drug Listing of Export Products. The team still has concerns about this issue since we received feedback from the Agency that the expectation is for export only products to be drug listed. Two team members volunteered to create a document to communicate to the DRLS of FDA. One person was going to write the full document and it would distributed and we would review as a group. This document has been circulated.


 * 2. DUNS Number Request:**

 D&B has an online tool that allows companies to search for a company's information and DUNS number. This report is called a Company Profile Report and is available at the following location: []  The fee for each report is $19.99 and is specific to each establishment. The Company Profile report gives a snapshot of a company's operations and key contact information on the executives at the company. The report is stored for six months in the View My Reports/Alerts section of your account. **3. Third Party Establishment Registration:**

Many third parties have not yet registered and many are registering at the end of the year. If an establishment has listed this year in paper, they can theoretically list next year which will be an even longer delay of electronic listing. This may be an issue with linking products to establishments and with no changes in regulations and no final guidance, they are not forced to change their process. Industry is looking to see if there is a way to make this a requirement for establishments. Follow up is needed with FDA.


 * 4. Delisting of Products:**

Products associated with establishments that duplicate an NDC number and are not the distributor will have to be delisted. This will result in a mass delist of products. Since the FDA has extended the submission of this beyond the June 1st deadline, many have made this a lessor priority and are focusing on creating SPL r4.


 * 5. Next meeting - April 29, 2009 at 11 AM Eastern Time.**