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."


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: 201201 Additional Q&A from DRLS.pdf
(including new CDER data rule linking establishments and NDC product code)
Dec 2011 - Q&A with DRLS 20111207 minutes Q&A DRLS.pdf
Nov 2011 - Update with Dun and Bradstreet: 20111109 Minutes of Update session with D&B.pdf
Mar 2011 - Q&A with DRLS and Import Group: 20110330 Min DRLS Import CMV.pdf

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-Leader to join this group.

Objective: Address questions and concerns regarding SPL that affect the pharma industry.Co-Leaders: Pat Cowall-Hanover (Lilly), Mary Beth Wilusz (Merck) and Herbert O'Brien (Bayer)

Standing Teleconference: Alternating Wednesdays at 1:00 pm ET

2016 Meeting minutes
April 20, 2016 Meeting Minutes


March 9 2016 Meeting Minutes


February 10, 2016 Meeting Minutes




2015 Meeting minutes
November 18, 2015 Meeting Minutes


November 4, 2015 Meeting Minutes


August 26, 2015 Meeting Minutes


July 29, 2015 Meeting Minutes


July 15, 2015 Meeting Minutes


May 20, 2015 Meeting Minutes


April 22, 2015 Meeting Minutes


March 25, 2015 Meeting Minutes


February 25, 2015 Meeting Minutes


January 14, 2015 Meeting Minutes



2014 Meeting minutes

November 19, 2014 Meeting Minutes

October 8, 2014 Meeting Minutes

September 24, 2014 Meeting Minutes

August 27, 2014 Meeting Minutes

July 16, 2014 Meeting Minutes

June 18, 2014 Meeting Minutes

May 21, 2014 Meeting Minutes

March 16, 2014 Meeting Minutes

February 26, 2014 Meeting Minutes

February 12, 2014 Meeting Minutes

January 15, 2014 Meeting Minutes


2013 Meeting minutes

December 12, 2013 Meeting Minutes

October 23, 2013 Meeting Minutes

September 11, 2013 Meeting Minutes

August 14, 2013 Meeting Minutes

July 31 2013 Meeting Minutes

May 22, 2013 Meeting Minutes

April 10, 2013 Meeting Minutes

Mar 13, 2013 Meeting Minutes



2012 Meeting minutes

August 1, 2012 Meeting Minutes

July 26, 2012 Process Team Minutes

June 5, 2012 Meeting minutes

May 23, 2012 Meeting minutes

May 9, 2012 Meeting minutes

May 9, 2012 Presentation

Apr 4, 2012 Meeting minutes

Mar 28, 2012 Meeting minutes

Jan 04, 2012 Meeting minutes

2011
Dec 07, 2011 Meeting Minutes


Nov 09, 2011 Meeting Minutes


Aug 03, 2011 Meeting Minutes


Jun 22, 2011 Meeting Minutes


Jun 08, 2011 Meeting Minutes


May 25, 2011 Meeting Minutes


May 11, 2011 Meeting Minutes


Apr 27, 2011 Meeting Minutes


Apr 13, 2011 Meeting Minutes


Mar 30, 2011 Meeting Minutes


Mar 02, 2011 Meeting Minutes


Feb 16, 2011 Meeting Minutes


Feb 02, 2011 Meeting Minutes


Jan 19, 2011 Meeting Minutes



2010
Dec 12, 2010 Meeting Minutes

Nov 10, 2010 Meeting Minutes

Oct 13, 2010 Meeting Minutes

Sep 15, 2010 Meeting Minutes

Aug 18, 2010 Meeting Minutes

Jul 21, 2010 Meeting Minutes

Jun 23, 2010 Meeting Minutes

Jun 09, 2010 Meeting Minutes

Apr 14, 2010 Meeting Minutes

Mar 03, 2010 Meeting Minutes

Feb 17, 2010 Meeting Minutes

Feb 02, 2010 Meeting Minutes


2011
2011_01_19 ER-DL Mtg Minutes.pdf
2011_02_02 ER-DL Mtg Minutes.pdf
2011_02_16 ER-DL Mtg Minutes.pdf