generics+--+5-05-09+Minutes

**May 5, 2009 **   1. Are you ready for SPL R4? What have you done to get ready?
 * Minutes for Generic HL7 SPL Sub Team **

We need your participation! 
 * One company reported that they have purchased software. They are currently training on it. The software is also being validated. They should be ready to go in July. **
 * Some notes from the discussion: **
 * Q1: If you have an inactive component and no UNII for it, what should be done? Is the UNII required for inactives? **
 * Regarding this, several questions were raised for Lonnie Smith at the FDA **
 * 1) **May these be submitted without the inactive components? And if they are submitted without inactives, how is the update done after submission? **
 * 2) **Will drug listings validate if there are inactive components without UNIIs? Will a manual process be involved? Or will the submission be routed back to the sponsor because of validation issues? **
 * The conclusion from the meeting was to not include the inactives until the UNIIs were available. This still leaves the questions about the update. **
 * Another sponsor has submitted NDC Labeler Code and our Drug Establishment information to FDA using the XFORMS for those pieces and it has been accepted and their 2009 Registration is shown on the Establishment/Registration pages. As for the Content of Labeling and Drug Listing, they attempted to use XFORMS for this for testing purposes only on several occasions and it was a disaster. Not user friendly and the user manual is awful. They still don’t know what happened to the content of labeling text that they entered, saved and then wanted to see again for editing purposes… couldn’t locate the text anywhere when they opened the form back up. They are going to continue to use the same software that they have been using for their SPL/PLR labels. There is a major upgrade to the software that will cover the R4 initiative.

** 2. New D&B service:

Has anyone used it? If so, how did it go?
 * There was no feedback on this. **

3. New Validator that FDA sent out.

Has anyone tried it?
 * There were several responses. The new validator is sensitive. **
 * Examples were raised: **
 * **Title containing the ampersand rather than the word 'and' **
 * **<span style="font-size: 12pt; font-family: 'Times New Roman','serif';">case sensitivity **
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">Also it was mentioned that running the validator successfully did not guarantee FDA will accept the listing **<span style="font-size: 12pt; font-family: 'Times New Roman','serif';">

4. Inactive ingredients:

Are all necessary?
 * They are requested but not required. See discussion above in item 1. **

5. SPL R4 Press Release:

GPhA sending out to members. **Informational – no discussion**

6. Virtify webinar this week:


 * Jeffery to give information. Jeffery sent out the invitation that he had seen. This was sent out a day before the webinar in ‘pre-minutes’. Jeffery attended and has slides for anyone who is interested. It was a good basic intro to SPL R4. It was vendor-sponsored but not vendor-centric.**

7. Name changes questions:

As with most name changes there is a grace period of converting the labeling components. As such, if the labeling has not changed yet, the re-submission of the Labeler Code form may be premature. It would be good to review the labeling change timeline and base the re-submission decision upon that information. **Informational – no discussion**

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mso-bidi-language: HE;"> <span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> <span style="font-size: 11.5pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">Where: <span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> <span style="font-size: 12pt; font-family: 'Times New Roman','serif';"> <span style="font-size: 12pt; font-family: 'Times New Roman','serif';"> <span style="font-size: 12pt; font-family: 'Times New Roman','serif';"> __<span style="font-size: 16pt; font-family: 'Arial','sans-serif';">Attendees __ <span style="font-size: 10pt; font-family: 'Arial','sans-serif';"> <span style="font-family: 'Helv','sans-serif';">Blik, Cheryl || <span style="font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-family: 'Helv','sans-serif';"> Cheryl.Blik@tevausa.com || <span style="font-family: 'Helv','sans-serif';">Brandt, Richard || <span style="font-family: 'Helv','sans-serif';">InVision Research || <span style="font-family: 'Helv','sans-serif';"> RBrandt@invisionresearch.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Cheng, Evelyn || <span style="font-family: 'Helv','sans-serif';">Teva Global Respiratory Research, LLC || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Evelyn.Cheng@tevausa.com || <span style="font-family: 'Helv','sans-serif';">Cobham, Michele || <span style="font-family: 'Helv','sans-serif';">Par Pharmaceutical || <span style="font-family: 'Helv','sans-serif';"> Michele.Cobham@parpharm.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Delaney, Marlene || <span style="font-family: 'Helv','sans-serif';"> || <span style="font-family: 'Helv','sans-serif';"> Marlene.Delaney@fmc-na.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Desai, Mona || <span style="font-family: 'Helv','sans-serif';">Interchem || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Mona@Interchem.com || <span style="font-family: 'Helv','sans-serif';">Frahn, Jane + 2 team members || <span style="font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-family: 'Helv','sans-serif';"> Jane.Frahn@tevausa.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Goff, Deborah || <span style="font-family: 'Helv','sans-serif';">Sandoz || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"><span style="font-size: 9pt; mso-bidi-font-family: Helv; mso-ascii-font-family: Helv; mso-hansi-font-family: Helv;">Deborah.Goff@sandoz.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Harvey, Mary || <span style="font-family: 'Helv','sans-serif';">Qualitest Pharmaceuticals || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"><span style="font-size: 9pt; mso-bidi-font-family: Helv; mso-ascii-font-family: Helv; mso-hansi-font-family: Helv;">MHarvey@qualitestrx.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Heater, Greg || <span style="font-family: 'Helv','sans-serif';">I4i || <span style="color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">gheater@i4i.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif';">Hogan, Virginia <span style="font-family: 'Helv','sans-serif';">Generic Sub Team Leader || <span style="font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-family: 'Helv','sans-serif';"> Virginia.Hogan@tevausa.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Howard, Marcia <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">OTC Team Coordinator <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Distribution only || <span style="font-family: 'Helv','sans-serif';">Consumer Healthcare Products Assoc. (CHPA) || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">MHoward@chpa-info.org || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Johns, Blessy || <span style="font-family: 'Helv','sans-serif';">Aurobindo || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">BJohns@aurobindousa.com || <span style="font-family: 'Helv','sans-serif';">Karp, Jeffery <span style="font-family: 'Helv','sans-serif';">Generics Sub Team Co Leader || <span style="font-family: 'Helv','sans-serif';">RA/IT Associates || <span style="font-family: 'Helv','sans-serif';"> JMKarp01@comcast.net || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Kirkeleit-Davis, Jean || <span style="font-family: 'Helv','sans-serif';">Hospira || <span style="font-family: 'Helv','sans-serif';">Jean.Kirkeleitdavis@hospira.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif';">Kirkner, Ruth || <span style="font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-family: 'Helv','sans-serif';"> Ruth.Kirkner@tevausa.com || <span style="font-family: 'Helv','sans-serif';">Lempka, Gayle || <span style="font-family: 'Helv','sans-serif';">Watson || <span style="font-family: 'Helv','sans-serif';"> Gayle.Lempka@watson.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Nestoros, Susan || <span style="font-family: 'Helv','sans-serif';">Barr Laboratories, Inc || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Susan.Nestoros@barrlabs.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Nolder, Peggy || <span style="font-family: 'Helv','sans-serif';">Sandoz || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">peggy.nolder@sandoz.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Peritore, Sal || <span style="font-family: 'Helv','sans-serif';">Barr Laboratories, Inc || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Sal.Peritore@barrlabs.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Pomraning, Jennifer || <span style="font-family: 'Helv','sans-serif';">Mylan Labs || <span style="font-family: 'Arial','sans-serif';">Jennifer.Pomraning@mylan.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Richesson, Cathleen || <span style="font-family: 'Helv','sans-serif';">Ben Venue Laboratories || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Arial;"> Cathleen.Richesson@boehringer-ingelheim.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Rosebush, Lee || <span style="font-family: 'Helv','sans-serif';">EpsteinBeckerGreen || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">LRosebush@ebglaw.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Roy, Milon || <span style="font-family: 'Helv','sans-serif';">Unichem || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">MRoy@Unichemusa.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Saner, Gary || <span style="font-family: 'Helv','sans-serif';">Reed Technology || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"><span style="font-size: 9pt; mso-bidi-font-family: Helv; mso-ascii-font-family: Helv; mso-hansi-font-family: Helv;">GSaner@reedtech.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Santoro, Amanda || <span style="font-family: 'Helv','sans-serif';">Hospira || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"><span style="font-size: 9pt; mso-bidi-font-family: Helv; mso-ascii-font-family: Helv; mso-hansi-font-family: Helv;">Amanda.Santoro@hospira.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Shatz, Howard || <span style="font-family: 'Helv','sans-serif';">Data Conversion Laboratory || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"><span style="font-size: 9pt; mso-bidi-font-family: Helv; mso-ascii-font-family: Helv; mso-hansi-font-family: Helv;">HShatz@dclab.com || <span style="font-family: 'Helv','sans-serif';">Shieh, Betty || <span style="font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-family: 'Helv','sans-serif';"> Betty.Shieh@tevausa.com <span style="font-family: 'Helv','sans-serif';"> || <span style="font-family: 'Helv','sans-serif';">Smith, Lonnie <span style="font-family: 'Helv','sans-serif';">Distribution list only || <span style="font-family: 'Helv','sans-serif';">FDA || <span style="font-family: 'Helv','sans-serif';"> Lonnie.Smith@fda.hhs.gov || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Strychar, Stefan || <span style="font-family: 'Helv','sans-serif';">Teva Pharmaceuticals || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Stefan.Strychar@TevaUSA.com || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Tenaglia, Paul || <span style="font-family: 'Helv','sans-serif';">Apotex, Inc. || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-size: 10.0pt; mso-bidi-font-family: Arial;"><span style="font-size: 9pt; mso-bidi-font-size: 10.0pt; mso-ascii-font-family: Helv; mso-hansi-font-family: Helv;">PTenaglia@apotex.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Thibodeau, Wendy || <span style="font-family: 'Helv','sans-serif';">Sandoz || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"><span style="font-size: 9pt; mso-bidi-font-family: Helv; mso-ascii-font-family: Helv; mso-hansi-font-family: Helv;">Wendy.Thibodeau@sandoz.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: 'Tms Rmn'; msobidifontfamily: 'Tms Rmn'; msospacerun: yes;"> <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;">Trautman, Craig || <span style="font-family: 'Helv','sans-serif';">Intagras || <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-size: 9.0pt; mso-bidi-font-family: Helv;">CTrautman@intagras.com <span style="font-family: 'Helv','sans-serif'; mso-bidi-font-family: Helv;"> || <span style="font-family: 'Helv','sans-serif';">Vu, Ann || <span style="font-family: 'Helv','sans-serif';">FDA, Office of Generics Drugs || <span style="font-family: 'Helv','sans-serif';"> Thuyanh.Vu@fda.hhs.gov <span style="font-family: 'Helv','sans-serif';"> || <span style="font-size: 10pt; font-family: 'Arial','sans-serif';">
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">A participant brought up an issue they had run into. They uploaded a label for a container and received an error message. The label can’t be seen it; it seems not to be attached. The FDA doesn’t see it either. It was suggested that this may be a reference issue in the XML. **
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">Is putting an image in with non standard LOINC OK? – Reed Tech suggests no; the principal display panel (PDP) section is what is requested for the image. **
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">What about the image of the carton? Reed Tech says they want to see whole carton; and PDP needs to contain the text of the customer facing panel. Intagras disagrees saying that this is recommended, not required. **
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">Another issue was raised regarding the same product under 2 labeler codes (sponsor and partner – different NDCs and companies) - One CoL exists. Does there need to another drug listing/CoL or no? **
 * <span style="font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">Reed Tech’s understanding is as follow: **
 * <span style="font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">Regarding the scenario where a product is manufactured and marketed by Company X and also sold to Company Y who simply sells the same product with a different NDC label (i.e., relabeler), it is my understanding… **<span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * · **<span style="font-size: 7pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> **<span style="font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">Company X must submit an SPL-Labeler Code Request, SPL-Establishment Registration, and SPL-Listing/Labeling. **<span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * · **<span style="font-size: 7pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> **<span style="font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">Company Y must submit an SPL-Labeler Code Request, SPL-Establishment Registration, and SPL-Listing/Labeling. Note that upon agreement, Company X may submit Company’s Y SPLs on their behalf. **<span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * · **<span style="font-size: 7pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> **<span style="font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">From the FDA Implementation Guide (3.1.1 ) and Instructions document (4.6.8), Company Y’s SPL-L/L can refer to the source NDC Product Code. Here is the snippet of applicable XML code using the <asEquivalentEntity> element: **<span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * <span style="background: white; color: blue; font-family: 'Arial','sans-serif'; mso-bidi-language: HE; mso-highlight: white;">< ****<span style="background: white; color: maroon; font-family: 'Arial','sans-serif'; mso-bidi-language: HE; mso-highlight: white;">manufacturedProduct ****<span style="background: white; color: blue; font-family: 'Arial','sans-serif'; mso-bidi-language: HE; mso-highlight: white;">> **<span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * //<span style="font-size: 11.5pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">1234-5678 //**<span style="font-size: 11.5pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> = relabeled NDC Product Code <span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * //<span style="font-size: 11.5pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">product name //**<span style="font-size: 11.5pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> = relabeled proprietary product name <span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * //<span style="font-size: 11.5pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">3333-4444 //**<span style="font-size: 11.5pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;"> = source NDC Product Code <span style="font-size: 12pt; font-family: 'Times New Roman','serif'; mso-bidi-language: HE;">
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">What about a sample label? This is similar to above and maybe should be a reviewer question. **
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">The question of export was raised again regarding an export only pharmaceutical. **
 * <span style="font-size: 12pt; font-family: 'Times New Roman','serif';">Unresolved. **
 * <span style="font-family: 'Helv','sans-serif';">Name ** ||
 * <span style="font-family: 'Helv','sans-serif';">Company ** ||
 * <span style="font-family: 'Helv','sans-serif';">E-mail ** ||
 * <span style="font-family: 'Helv','sans-serif';">E-mail ** ||