Generics+--+12-15-08+minutes

**December 15, 2008** Our first 2009 meeting would be Tuesday, January 13 at 1:00 pm & continue as every 4th Tuesday.  ·  **  Name of drug  **  ·  **  Strength & unit  **  ·  **  Discontinuation date (may be future dated)  **  ·  **  NDC Number  **  ** A15: R3 is different then R4 because R4 has a marketing date that determines the release of the document whereas final versions of R3 SPL documents (annual report, final SPL or safety CBE are manually sent to NLM based on a decision made by an FDA employee. **  ** Announcement from Lonnie Smith: FDA will be providing **** webinars/training courses at no charge for the New Year - beginning in February and continuing to mid March then repeating each session. These will include a final face-to-face session in Bethesda in May. These will discuss and break-down the process. **   5. Drug Registration – you can register what you have electronically & the rest via paper now and next year you can just register the missing ones.   **  Yes, you can register some drug establishments and list drug products in paper and others electronically and then update the SPL R4 documents to include the remaining drug establishments or drug products. **  ** Tom Marsden and Virginia Hogan’s discussion: **
 * Meeting Minutes for SPL Generic Sub Team Meeting **
 * 1)  Meeting minutes from 11/17/08 – are posted on the Wiki site – any questions, additions, etc?
 * Meeting minutes were accepted and there were no questions. **
 * 1)  Beginning in January we will meet every 4th Tuesday instead of every other Monday so that we do not overlap with the OTC group. This may change as we get closer to the June 1, 2009 date. If we get agenda items, we will call a meeting on our “off” Tuesdays. I have received feedback that people do not have outstanding items; they are waiting for the final guidance and their software to be ready as they get the Duns numbers etc. together.
 * The change of date for the meeting was acknowledged. The only issue of note was of the RPS group having overlap occasionally (approx. once a quarter.) The meetings will start in the New Year on January 13 and continue on every 4th Tuesday. Meeting invitations have been sent out with the new date, if you have not received one, please contact Virginia Hogan. **
 * Tom Marsden of Dun & Bradstreet will be speaking with us at Jan 13th meeting. **
 * 1)  Any questions for Lonnie Smith/FDA regarding his December 3, 2008 presentation “Electronic Drug Listing in SPL Format”?
 * The questions for Lonnie were mixed in with the questions on his presentation (see below.) **
 * 1)  Lonnie Smith/FDA to discuss delisting strategies and other issues prior to SPL R4.
 * Lonnie’s presentation – Issues of delisting – How to mass delist prior to the date when the electronic submission of drug establishment registration and drug listing information is mandatory. **
 * This discussion is about NDC delisting. This would be to clean up NDC lists and avoid having to submit the SPL just to have it removed. **
 * The information the FDA needs is: **
 * The above is sufficient to remove NDC numbers from the NDC database. You may put in an Excel spreadsheet with the above information and send it to: spl@fda.hhs.gov  prior to June 1, 2009.   **
 * Some questions posed to Lonnie: **
 * Q1: What about imports/exports? **
 * A1: If the manufacturer NDC is to be discontinued – send in the same way as above. If you have a concern regarding the FDA Imports Staff processing your imports with the discontinuation date, put it in for 2 years from now. Some products will not have listing changes. FDA Imports Staff will still check their own database. **
 * Q2: What about the DRLS database? **
 * A2: FDA is keeping the DRLS database up and running **
 * Q3: What is being done to update the import staff? **
 * A3: Lonnie Smith and Randy Levin have been meeting with employees in the FDA import staff training office. **
 * Q4: What is the discontinuation date? **
 * A4: The discontinuation date (end marketing date in an SPL document) can be the product’s shelf life expiration date. **
 * Q5: Where do we send the delisting request? **
 * A5: Send to SPL email address SPL@FDA.hhs.gov **
 * Q6: How should the email be titled? **
 * A6: “NDC Delisting” **
 * Q7: What should be used for the drug name? **
 * A7: The trade name, unless it is a generic product. **
 * Q8: Until when can this be done? **
 * A8: For drugs, June 2009; For manufacturers’ NDCs TBD **
 * Q9: What about OOB (Out of Business)? **
 * A9: Company is going out of business – labeler code will no longer be used. Can we just discontinue the labeler code and it will delete all NDC’s under it? * Post meeting note – the answer so far is “no”.  **
 * Q10: What is the manufacturer establishment referred to here? **
 * A10: This is the Foreign Manufacturer NDC used for Customs & FDA import that is used on invoices for product to come into the country. This is drug listed to the same label as the actual NDC number and label. Usual date for delisting would be 2 years from discontinuation date – can put this as discontinuation date on spreadsheet. **
 * Other Questions  **
 * Establishment Registration and Drug Listing (ER/DL) **
 * Q11: How do you list a product prior to launch? **
 * A11: One method is imminent approval document **
 * Q11-2 What about during the scale up? That is post IND and pre-NDA approval? **
 * A11-2: Draft PI may be submitted as the content of labeling of an SPL R4 CoL/listing file to list drug products prior to approval of an application. They won't be posted to National Library of Medicine DailyMed (NLM) and FACTS@FDA website until SPL marketing date arrives – MUST KEEP AN EYE ON THE APPROVAL/MARKETING DATE – if this date comes and you are not marketing it, it will still show up on the web site unless you change the date. **
 * Q12: In the past, it took up to 60 days for processing the paper drug listing submission. How is this changing? Will it be immediate?  **
 * A12: 24 to 48 hrs. Getting the electronic submission processed should be quick because the valid SPL Release Four documents are processed automatically. **
 * Q13: If we submit draft SPL, will it be ever submitted to NLM? **
 * A13: When an SPL R4 update is sent, it changes queued item to be sent to NLM. The release of an SPL R4 is based on the marketing start date entered by the SPL author in the SPL document. **
 * Q14: Who controls what information is released to the public? **
 * A14: The applicants determine when information is released to the public with the marketing date value in the SPL R4 document. **
 * Q15: How is label in R3 and R4 sent to NLM? **
 * 1)  DUNS Numbers – Follow up with D&B – we are having issues getting numbers – anyone else?
 * 5.1. Several vendors have contracted to provide DUNS #s to their customers. More vendors may participate.

5.2. If you are an existing D&B customer you should go through your internal D&B representative. To find out other DUNS#s outside of your company there is an inquiry charge at D&B.com with a DUNS# lookup feature at a fraction of the full report charge. Tom will check the price schedule and let Virginia know prior to the 1:00 meeting today.

Answer: [Marsden, Thomas] Pharmaceutical companies that are subscribers to D&B services delivered through [|www.dnb.com] can query and retrieve a DUNS Number through this service. The DUNS Number data element is published on all D&B report products but the most cost effective product to meet FDA SPL submission needs is the "D&B ID Report." Retail pricing for this product varies depending upon the type of subscription contract (i.e., annual or monthly) and discount eligibility; the undiscounted price is $3.55 per report. 5.3. If you are not an existing D&B customer you can contact Julie Newman to set up an account for SPL DUNS#s only. Tom will provide her information to Virginia.

Answer: [Marsden, Thomas]   ** 5.4. D&B did a search of the Drug Registration & Listing database and determined that about 1200 out of 25,000 are currently D&B customers.
 * Julie Newman  **
 * newmanju@dnb.com  **
 * 703.807.5091  **

5.5. In regards to our company’s request for DUNS#s for 2 major manufacturing sites in Israel and Ireland, the request has been put through and usually takes about 30 days. You are expecting a response to us within a week from now.

5.6. Tom will participate on our next Generic Sub Team meeting on Tuesday, January 13 at 1:00 ET to further discuss this with the group and answer any questions. **  ** Meeting Attendance for 12/15/08  ** Benyo, Laurel || Ben Venue Laboratories ||  Laurel.Benyo@boehringer-ingelheim.com || Blik, Cheryl || Teva Pharmaceuticals ||  Cheryl.Blik@tevausa.com || Brunone, Theresa || Glaxo Smith Kline ||  Theresa.Brunone@gsk.com || Feliciano, Iris <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sun Pharmaceutical Industries, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Iris.Feliciano@sunpharmausa.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Halleran, Sue || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">West-ward Pharmaceutical Corp. || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">SHalleran@west-ward.net || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Harvey, Mary || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> MHarvey@qualitestrx.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Hogan, Virginia <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Generic Sub Team Leader || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Virginia.Hogan@tevausa.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Karp, Jeffery <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Generics Sub Team Co Leader || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">RA/IT Associates || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> JMKarp01@comcast.net || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Keller, Jamie || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Glenmark Generics, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial; mso-bidi-font-size: 10.0pt;">JamieK@glenmark-generics.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Kirkner, Ruth || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Ruth.Kirkner@tevausa.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Lempka, Gayle || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Watson || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Gayle.Lempka@watson.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">McNeal, Katherine || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">NYCOMED || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Katherine.McNeal@NYComedus.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Morgan, Devon <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">OTC Sub Team co-leader <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Distribution only || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Perrigo Company || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> Devon.Morgan@Perrigo .com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Nguyen, Wafa || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> WNguyen@qualitestrx.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Nolder, Peggy || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Sandoz || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">peggy.nolder@sandoz.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Peritore, Sal || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Barr Laboratories, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Sal.Peritore@barrlabs.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Pomraning, Jennifer || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Mylan Labs || <span style="font-size: 11pt; font-family: 'Arial','sans-serif';">Jennifer.Pomraning@mylan.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Richesson, Cathleen || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Ben Venue Laboratories || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial;"> Cathleen.Richesson@boehringer-ingelheim.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Roy, Milon || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Unichem || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">MRoy@Unichemusa.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Shieh, Betty || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Betty.Shieh@tevausa.com <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Smith, Lonnie || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">FDA || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';"> Lonnie.Smith@fda.hhs.gov || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Strychar, Stefan <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">+ 3 team members <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Stefan.Strychar@TevaUSA.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial; mso-bidi-font-size: 10.0pt;">Vasquez, Karen || <span style="font-size: 11pt; font-family: 'Helv','sans-serif';">Roxane Laboratories, Inc || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial;">Karen.Vasquez@boehringer-ingelheim.com || <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt;">Additional Attendees: <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt;"> <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt;">Patricia Cowall <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt;">Dragan Obradovich <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt;">Michael Fahmy <span style="font-size: 11pt; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt;">Grace Minh
 * 1)  Software: When are you expecting your software for SPL R4?
 * We did not get many answers, but several companies reported privately to us that they are expecting it at the end of March. There is some concern about getting it validated and ready to go. **
 * 1)  SPL Survey ready to go – Jeffery Karp.
 * Discussion and demo postponed for next meeting. **
 * 1)  Any other business.
 * None. 30 attendees, attendance list on next page. **
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