Meeting+Minutes+May+13+2009+DL&ER+Workgroup


 * 1. Two Business Functions With One Physical Address:**

There are some companies that have more than one function (i.e., Rx products along with Vet meds) that are manufactured within the same physical address. D&B has only assigned one DUNS number for this address whereas the entities are completely separate. Others have different divisions that have historically been entered onto a FDA Form 2656 in the "Also doing business as" (DBA) section. The group recommends including this section within the SPL to carry over this information from the paper format.

FDA Follow up: FDA has no issues with different corporate entities having different names and the same DUNS number.

D&B has also given the option of requesting a DBA for an existing site to get a new DUNS number


 * 2. Repackaging Products that have been Listed:**

A current repackager has several products that are purchased from multiple sources. Depending on current pricing, the repackager may purchase the same product from any number of given sources. Under the paper format, the repackager would submit a 2657 form with the final site and submit the document once to FDA with the new NDC number. Under the new process, the repackager would have to list every time a product was purchased from a new source. This may lead to thousands of SPL submissions.

FDA follow up: FDA needs to know the source of the product that is being listed. This will result in more submissions.


 * 3. More than One labler Code for One Product:**

There are instances where companies have more than one labeler code for a particular product. This can appear this way on the Package Insert but will cause a validation error in SPL r4.

FDA follow up: Two different SPL files for the two different labelers will be an acceptable approach.


 * 4. Source NDC codes:**

People are proposing to use source NDC codes for manufacturers. This causes validation issues because there is SPL content that is missing.

Follow up: Source NDC codes are intended for repackagers


 * 5. Next meeting - May 28, 2009 at 2 PM Eastern Time.**