Drug+Listing

=SPL Process, Drug Listing, and Establishment Registration=

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*Drug Listing and Establishment Registration Guidance Document*
"... **Beginning June 1, 2009**, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted."
 * [|Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing]

[|Product Identification System] Accessible from DailyMed
National Library of Medicine (NLM) has launched a new feature on its DailyMed website: the Product Identification System. NLM utilizes the data in the SPL documents with images of products which they have on file. For instance, if you 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. Double-clicking on the image takes you to the SPL document.

FDA instituted the Drug Listing Act of 1972, this regulatory policy is in the [|21 Code of Federal Regulations (CFR) Part 207]. The 21 CFR Part 207 addresses [|definitions], drug registration requirements, and drug listing requirements by FDA.

Drug Listing information is available publicly on the [|NDC Directory]

Drug Firm Annual Registration Status Database is on the http://www.fda.gov/cder/dfars/docs/querydrls.htm

Current Drug Registration and Listing Instructions are located at http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM162027.pdf

A list of registration and listing requirements for the manufacture or distribution of human pharmaceuticals (What establishments need to list) is located here. Validation rules have been drafted for [|electronic submission of Drug Listings].

**Special Q&As Sessions:**
Jan 2012 - Additional questions: (including new CDER data rule linking establishments and NDC product code) Dec 2011 - Q&A with DRLS Nov 2011 - Update with Dun and Bradstreet: Mar 2011 - Q&A with DRLS and Import Group:

Drug Listing Terminology is here Drug Listing Q&A is here DUNS Q&A is here Drug Listing Scenarios Q&A [July 2010] with the FDA's Drug Registration and Listing Group [|here]

Drug Listing and Electronic Registration Working Group
Contact any of the Co-Leaders to join this group.

**Objective:** Address questions and concerns regarding SPL that affect the pharma industry.**Co-Leaders**: Ben Harpster (GSK) and Herbert O'Brien (Bayer)


 * Standing Teleconference**: Alternating Wednesdays at 1:00 pm ET, balance of 2017: October 4 and 18, November 1, 15, and 29, December 13 and 27


 * 2018 Meeting minutes**
 * March 07, 2018 Meeting Minutes ||< [[file:20180307 SPL ERDL minutes.pdf]] ||  ||


 * 2017 Meeting minutes**
 * December 13, 2017 Meeting Minutes ||< [[file:20171213 SPL ERDL minutes.pdf]] ||  ||
 * November 15, 2017 Meeting Minutes ||< [[file:20171115 SPL ERDL minutes.pdf]] ||  ||
 * September 20, 2017 Meeting Minutes ||< [[file:20170920 SPL ERDL minutes.pdf]] ||  ||
 * August 23, 2017 Meeting Minutes - slide presentation by Lonnie Smith ||< [[file:20170823 industry_spl_process_team_spl_data_standards_perspective.pdf]] ||  ||
 * July 26, 2017 Meeting Minutes ||< [[file:20170726 SPL ERDL minutes.pdf]] ||  ||
 * June 14, 2017 Meeting Minutes ||< [[file:20170614 SPL ERDL minutes.pdf]] ||  ||
 * May 17, 2017 Meeting Minutes ||< [[file:20170517 SPL ERDL minutes final - Corrected.pdf]] ||  ||
 * April 05, 2017 Meeting Minutes ||< [[file:20170405 SPL ERDL minutes final - IDMP_replacement doc types_other.pdf]] ||  ||
 * March 22, 2017 Meeting Minutes ||< [[file:20170322 SPL ERDL minutes - IDMP Timeline update_ Bayer.pptx]] ||  ||
 * January 17, 2017 Meeting Minutes ||< [[file:20170111 SPL ERDL minutes - final rule_MEI- w FDA responses.pdf]] ||  ||


 * 2016 Meeting minutes**
 * October 19, 2016 Meeting Minutes ||< [[file:20161019 SPL ERDL minutes-FINAL.pdf]] || [[file:20161019 Leyla Final Rule SPL_WGPresentation.pptx]] || [[file:20161019 SPLJamboreeSlidesLoebach.pptx]] ||
 * August 10, 2016 Meeting Minutes ||< [[file:20160810 SPL ERDL minutes.pdf]] ||  ||
 * July 27, 2016 Meeting Minutes ||< [[file:20160727 SPL ERDL minutes.pdf]] ||  ||
 * April 20, 2016 Meeting Minutes ||< [[file:20160420 SPL ERDL minutes.pdf]] || [[file:20160420 SPL Mtg attachment question on alternate image text on DailyMed.pdf]] ||
 * March 9 2016 Meeting Minutes ||< [[file:20160309 SPL ERDL minutes.pdf]] ||  ||
 * February 10, 2016 Meeting Minutes ||< [[file:20160210 SPL ERDL minutes.pdf]] || [[file:20160210 SPL ERDL minutes attachment 21CFR 201.1 Corporate Name - Labeling 2014.pdf]] ||


 * 2015 Meeting minutes**
 * November 18, 2015 Meeting Minutes ||< [[file:20151118 SPL ERDL minutes LDR FDA mtg final.pdf]] ||  ||
 * November 4, 2015 Meeting Minutes ||< [[file:20151104 SPL ERDL minutes final.pdf]] ||  ||
 * August 26, 2015 Meeting Minutes ||< [[file:20150826 SPL ERDL minutes.pdf]] ||  ||
 * July 29, 2015 Meeting Minutes ||< [[file:20150729 SPL ERDL minutes.pdf]] || [[file:20150729 Attachment IDMP Update 2015-07.pdf]] ||
 * July 15, 2015 Meeting Minutes ||< [[file:20150715 SPL ERDL minutes.pdf]] ||  ||
 * May 20, 2015 Meeting Minutes ||< [[file:20150520 SPL ERDL minutes.pdf]] ||  ||
 * April 22, 2015 Meeting Minutes ||< [[file:20150422 SPL ERDL minutes.pdf]] ||  ||
 * March 25, 2015 Meeting Minutes ||< [[file:20150325 SPL ERDL minutes.pdf]] ||  ||
 * February 25, 2015 Meeting Minutes ||< [[file:20150225 SPL ERDL minutes.pdf]] ||  ||
 * January 14, 2015 Meeting Minutes ||< [[file:20150114 SPL ERDL minutes.pdf]] || [[file:20150114 Paperless Labeling Rule Notes.pptx]] ||


 * 2014 Meeting minutes**


 * November 19, 2014 Meeting Minutes ||< [[file:20141119 SPL ERDL minutes.pdf]] ||
 * October 8, 2014 Meeting Minutes ||< [[file:20141008 SPL ERDL minutes.pdf]] ||
 * < September 24, 2014 Meeting Minutes ||< [[file:20140924 SPL ERDL minutes.pdf]] ||
 * August 27, 2014 Meeting Minutes ||< [[file:20140827 SPL ERDL minutes final.pdf]] ||
 * July 16, 2014 Meeting Minutes ||< [[file:20140716 SPL ERDL minutes.pdf]] ||
 * June 18, 2014 Meeting Minutes ||< [[file:20140618 SPL ERDL minutes.pdf]] ||
 * May 21, 2014 Meeting Minutes ||< [[file:20140521 SPL ERDL minutes.pdf]] ||
 * March 16, 2014 Meeting Minutes ||< [[file:20140326 SPL ERDL minutes.pdf]] ||
 * February 26, 2014 Meeting Minutes ||< [[file:20140226 SPL ERDL minutes.pdf]] ||
 * February 12, 2014 Meeting Minutes ||< [[file:20140212 SPL ERDL minutes - comb products and label rev dates.pdf]] ||
 * January 15, 2014 Meeting Minutes || [[file:20140115 SPL ERDL Minutes.pdf]] ||


 * 2013 Meeting minutes**


 * December 12, 2013 Meeting Minutes || [[file:20131204 SPL ERDL Minutes final.pdf]] ||
 * October 23, 2013 Meeting Minutes || [[file:20131023 SPL ERDL Minutes final.pdf]] ||
 * September 11, 2013 Meeting Minutes || [[file:20130911 SPL ERDL Minutes final.pdf]] ||
 * August 14, 2013 Meeting Minutes || [[file:20130814 SPL ERDL Minutes - including DnB update.pdf]] ||
 * July 31 2013 Meeting Minutes || [[file:20130731 SPL ERDL Minutes - including DnB update and new stylesheet .pdf]] ||
 * May 22, 2013 Meeting Minutes || [[file:20130522 SPL ERDL Minutes.pdf]] ||
 * April 10, 2013 Meeting Minutes || [[file:20130410 SPL ERDL Minutes.pdf]] ||
 * Mar 13, 2013 Meeting Minutes || [[file:20130313 SPL ERDL Minutes.pdf]] ||


 * 2012 Meeting minutes**


 * August 1, 2012 Meeting Minutes || [[file:20120801 SPL ERDL Minutes.pdf]] ||
 * July 26, 2012 Process Team Minutes || [[file:20120726 Process Mtg Minutes.pdf]] ||
 * June 5, 2012 Meeting minutes || [[file:20120606 Minutes SPL ERDL Skorups.pdf]] ||
 * May 23, 2012 Meeting minutes || [[file:20120523 SPL ERDL Minutes.pdf]] ||
 * May 9, 2012 Meeting minutes || [[file:20120509 SPL ERDL Minutes.pdf]] ||
 * May 9, 2012 Presentation || [[file:20120509 Presentation Active Ingredient-Active Moiety Relationship in SPL-rev6.pdf]] ||
 * Apr 4, 2012 Meeting minutes || [[file:20120411 ER-DL Mtg Minutes.pdf]] ||
 * Mar 28, 2012 Meeting minutes || [[file:20120328 erdl draft minutes jessica.pdf]] ||
 * Jan 04, 2012 Meeting minutes || [[file:spl-work-group/20120104 Min Update from DRLS Q&A.pdf]] ||
 * 2011**
 * Dec 07, 2011 Meeting Minutes || [[file:spl-work-group/20111207 minutes Q&A DRLS v4-draft.pdf]] ||  ||
 * Nov 09, 2011 Meeting Minutes || [[file:spl-work-group/20111109 Minutes Update session with D&B.pdf]] || [[file:spl-work-group/20111109 D and B presentation.pdf]] ||
 * Aug 03, 2011 Meeting Minutes || [[file:spl-work-group/20110803 Minutes general discussion.pdf]] ||  ||
 * Jun 22, 2011 Meeting Minutes || [[file:spl-work-group/20110622 Minutes General discussion.pdf]] ||  ||
 * Jun 08, 2011 Meeting Minutes || [[file:spl-work-group/20110608 Minutes Pillbox.pdf]] ||  ||
 * May 25, 2011 Meeting Minutes || [[file:spl-work-group/20110525 Minutes General discussion.pdf]] ||  ||
 * May 11, 2011 Meeting Minutes || [[file:spl-work-group/20110511 Minutes First Data Bank.pdf]] || [[file:spl-work-group/20110511 Other Notes First Data Bank.pdf]] ||
 * Apr 27, 2011 Meeting Minutes || [[file:spl-work-group/20110427 Min Q&A DRLS CMS.pdf]] ||  ||
 * Apr 13, 2011 Meeting Minutes || [[file:spl-work-group/20110413 Minutes General Discussion.pdf]] ||  ||
 * Mar 30, 2011 Meeting Minutes || [[file:spl-work-group/20110330 Min DRLS Import CMV.pdf]] ||  ||
 * Mar 02, 2011 Meeting Minutes || [[file:spl-work-group/20110302 Minutes General Discussion.pdf]] ||  ||
 * Feb 16, 2011 Meeting Minutes || [[file:spl-work-group/20110216 Minutes General Discussion.pdf]] ||  ||
 * Feb 02, 2011 Meeting Minutes || [[file:spl-work-group/20110202 Minutes General Discussion.pdf]] ||  ||
 * Jan 19, 2011 Meeting Minutes || [[file:spl-work-group/20110119 Minutes General Discussion.pdf]] ||  ||


 * 2010**
 * Dec 12, 2010 Meeting Minutes || [[file:spl-work-group/2010-12-08 SPL DL_ER Mtg Min.pdf]] ||
 * Nov 10, 2010 Meeting Minutes || [[file:spl-work-group/2010-11-10 SPL DL_ER Mtg Min.pdf]] ||
 * Oct 13, 2010 Meeting Minutes || [[file:spl-work-group/2010-10-13 SPL DL_ER Mtg Min.pdf]] ||
 * Sep 15, 2010 Meeting Minutes || [[file:spl-work-group/2010-09-15 SPL DL_ER Mtg Min.pdf]] ||
 * Aug 18, 2010 Meeting Minutes || [[file:spl-work-group/2010-08-18 SPL DL_ER Mtg Min.pdf]] ||
 * Jul 21, 2010 Meeting Minutes || [[file:spl-work-group/2010-07-21 SPL ER DL Minutes - DRLS meeting final.pdf]] ||
 * Jun 23, 2010 Meeting Minutes || [[file:spl-work-group/2010-06-23 SPL ER_DL Mtg Min.pdf]] ||
 * Jun 09, 2010 Meeting Minutes || [[file:spl-work-group/2010-06-09 SPL DL_ER Minutes DLWG 06-09-10.pdf]] ||
 * Apr 14, 2010 Meeting Minutes || [[file:spl-work-group/2010-04-14 SPL DL_ER Mtg Min mh.pdf]] ||
 * Mar 03, 2010 Meeting Minutes || [[file:spl-work-group/2010-03-03 SPL DL_ER Mtg Min.pdf]] ||
 * Feb 17, 2010 Meeting Minutes || [[file:spl-work-group/2010-02-17 SPL DL_ER Mtg Min Feb_17_2010 final.pdf]] ||
 * Feb 02, 2010 Meeting Minutes || [[file:spl-work-group/2010-01-20 SPL DL_ER Mtg Min 2010Jan20.pdf]] ||


 * 2011**