Meeting+Minutes+Apr-29-09+DL&ER+Workgroup


 * 1. Export Only Products:**

Team will review document to communicate issues to DRLS regarding export only products. Document was circulated for the team's review prior to last meeting. Exhibit documents will be forwarded for complete review.


 * 2. Product Image in SPL for DailyMed:**

The National Library of Medicine (NLM) is proposing a high resolution image capture of final dosage products. This would entail sponsors sending in a sample of product to the NLM and a high resolution photograph would be taken of the product. The file would be sent back to the sponsor in a JPG format and a high resolution, uncompressed copy of the image would be maintained with NLM. Many sponsors disucssed concerns during the discussion. Some were concerned that this may increase the probability of counterfeiting, others wanted to know how the image would be protected and whether this would apply to controlled substances that have to be drug listed for export only. There were several other concerns. Since there are no official plans, discussions may follow once details become more available.

Additionally, the NLM has launched a new feature on it's DailyMed website: Product Identification System, which utilizes the data in the SPL documents with images of products which they have on file. This feature is located on []. If one were to type in a color such as "blue," one will find all of the products which have the color blue that are described in SPL documents on DailyMed. If one were to scroll down the web page, one will notice that there are some images of the products which NLM already had on file. Hovering the computer mouse cursor over the image will render a larger version of the images.


 * 3. General Contacts for SPL files:**

Some companies are in the process of pulling together SPL files. It seems that many companies are trying to centralize their contacts to mainstream the communication process if questions come in from the Agency. The contacts seem to be localized to the QA group.


 * 4. Processing of files:**

Several questions about processing files still exist. The level of detail is still in question as to the establishments that need to be included in a SPL file. Many are trying to follow the level of detail in their U.S. marketing application (NDA, ANDA, BLA, etc.) We have been instructed by the Agency not to include back up facilities but only to include those that are active in the processing of a product. This does include analytical labs. If a contract manufacturer contracts to a third party manufacturer, would this be included in the SPL? If manufacturers from the application are used in the SPL file, this seems to be the extent that companies may be able to report. Follow up may be needed on this.

Additionally, there are companies that have more than one function, such as Rx products and Vet meds. If these entities are located in the same facility, they may have the same address, DUNS, etc. In the paper world, the FDA form 2656 had an "Also doing business as" (DBA) section of the form. Electronically, there is no way this is handled. Follow up with FDA will be needed on this.

The June 1st deadline is quickly approaching and many companies are not sure how to proceed since there is no final guidance document. Some may start requesting waivers to the SPL requirement until a process is worked out post guidance issuance.
 * 5. Waiver Requests**


 * 6. Next meeting - May 13, 2009 at 11 AM Eastern Time.**