Meeting+Minutes+Jun+24+2009+DL&ER+Workgroup


 * **1.** **PLAIR (Pre-Launch Activities Importation Request) for Unapproved Product:**

There was a discussion around importation and drug listing in r4 under PLAIR (pre-launch activities importation request) for unapproved product and drug listing mechanism. Currently there is no mechanism with the new electronic format, but this will need to be discussed with the ports. Can an SPL r4 file with minimal information in content of labeling and a future effective date be a be the route of submission? A follow up with FDA will be necessary.

Requests for new UNII Codes are sent to the SPL e-mail. If an inactive ingredient source is covered by a DMF, where the ingredients are proprietary and is listed on the PI, is the DMF number enough for FDA to provide a code?, If not, what additional information would be needed? Can the DMF holder provide a UNII for their product and mark it as confidential? Can FDA find a UNII code for a DMF from a DMF number? Does edible ink need to be listed? The team does not believe so.
 * 2. UNII Codes and DMFs :**


 * 3. SPL r4 Waivers:**

FDA gives guidance on where to submit electronic ER/DL waivers to the Agency. There is no timing that is included in the guidance. If a waiver is submitted, members of the team are looking for information on the time frame that it will take to get approval of a waiver. Follow up with FDA will be needed.


 * 4. NDC Directory:**

There are many organizations that rely on the information in the NDC directory including some reimbursement agencies. The NDC directory is updated monthly and the date of the most resent update is located within the page. The link is below:

[|**http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm**]


 * 5. Packaging Error:**

At the SPL Process team meeting, there were some individuals that stated they are getting a packaging error after they send an SPL r4 file in. FDA stated that there is a known issue when there are specific differences between r4 and r3 files and in these instances to notify FDA that it is coming through.


 * 6. Next meeting - July 8, 2009 at 1 PM Eastern Time.** || Cancel ||
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