Meeting+Minutes+Nov-5-08+DL&ER+WorkgroupEdit

**1. Delisting Issues:**  Currently, many organizations have inaccuracies in the NDC Drug Code Directory. Many organizations have changes that need to be made for various reasons. Some have a long list of products. Traditionally, these changes have been made via FDA Form 2657 to delist each product. Others have delisted by obtaining a Compliance Verification Report from the Agency and marking off products that need to be removed or revised. When the process becomes electronic, this will also have to be done electronically. One question that arises is "**Will there be validation errors if content of labeling and representative samples of the labeling are missing. If a complete product needs to be deleted, what aspects of the SPL will be needed.? Will including a market end date remove a product from the NDC Drug Code Directory as well**?" This uncertainty has resulted in many trying to quickly gather the information to submit one bolus of delisting information to the Agency. This can potentially slow down each organization from quickly getting their drug listing together prior to the June 2009 deadline, and will also be a huge burden to FDA to make changes in the present database. The team thought it would be best to pose this question to FDA to figure out a solution to make this less daunting.

**2. Follow up with FDA on SPL Drug Listing: ** After a meeting was organized with FDA and D&B which went into specifics on the Establishment Registration, the teams thought it would be necessary to have a follow up meeting regarding the actual drug listing of products and to include the Drug Listing Agency in a teleconference. This would allow individuals to follow the creation of an SPL and give them the ability to ask drug listing questions with specifics on the regulations.  ** 3. Case Scenarios: ** There were several questions on products coming from overseas and how they will be logistically listed. The process will be significantly different from the current process as NDC numbers will no longer be needed for manufacturers if a distributor drug lists for them. However, products coming over the border will need to be listed prior to being allowed into the country. Some Case Scenarios will be drawn up and sent to FDA for guidance on the needed process flow. ** 4 Regulation changes:      ** The regulations reference the FDA Forms. This may either need to be changed in the regulations or the Guidance may have to map out how certain fields in the electronic format will fullfil the regulatory obligations within the forms. Perhaps even some sort of mapping may be needed.

 ** 5. Federal Register Notice: **  A Federal Register Notice was issued on October 23rd, 2008 regarding the estimated annual recordkeeping burden of the new electronic process for establishment registation and drug listing. Many members of the team wanted to submit comments. Each member will gather comments and send them in prior to the next meeting to ensure we can submit them through PhRMA. The notice can be found at the following location: [|__http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-25338.pdf__]


 * 6. Next meeting will be on Nov. 19, 2008 at 1 pm EDST.**