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/cder/drls/default.htm

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 Jessica Skorupski (J&J)

Standing Teleconference: Alternating Wednesdays at 1:00 pm ET (Opposite weeks to SPL Process Team)

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

20120104 Min Update from DRLS Q&A.pdf
2011
20110119 Minutes General Discussion.pdf
20110202 Minutes General Discussion.pdf
20110216 Minutes General Discussion.pdf
20110302 Minutes General Discussion.pdf
20110330 Min DRLS Import CMV.pdf
20110413 Minutes General Discussion.pdf
20110427 Min Q&A DRLS CMS.pdf
20110511 Minutes First Data Bank.pdf
20110511 Other Notes First Data Bank.pdf
20110525 Minutes General discussion.pdf
20110608 Minutes Pillbox.pdf
20110622 Minutes General discussion.pdf
20110803 Minutes general discussion.pdf
20111109 Minutes Update session with D&B.pdf
20111109 D and B presentation.pdf
20111207 minutes Q&A DRLS v4-draft.pdf
2010
2010-01-20 SPL DL_ER Mtg Min 2010Jan20.pdf
2010-02-17 SPL DL_ER Mtg Min Feb_17_2010 final.pdf
2010-03-03 SPL DL_ER Mtg Min.pdf
2010-04-14 SPL DL_ER Mtg Min mh.pdf
2010-06-09 SPL DL_ER Minutes DLWG 06-09-10.pdf
2010-06-23 SPL ER_DL Mtg Min.pdf
2010-07-21 SPL ER DL Minutes - DRLS meeting final.pdf
2010-08-18 SPL DL_ER Mtg Min.pdf
2010-09-15 SPL DL_ER Mtg Min.pdf
2010-10-13 SPL DL_ER Mtg Min.pdf
2010-11-10 SPL DL_ER Mtg Min.pdf
2010-12-08 SPL DL_ER Mtg Min.pdf

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