Process for Submission and Drug Listing Rx Human Drugs*

1. Process for Submission and Drug Listing Rx Human Drugs* • Posting to Daily Med • SPL r3 - occurs via the FDA application process utilizing ELIPS • SPL r4 - occurs via the Drug Listing process utilizing eList • Initial transition to SPL r4 will require duplicate submissions to the Application Process and the Drug Listing Process to accomplish posting to the Daily Med (those using the Gateway will have to make 2 submissions of the same file to different destinations at FDA). Work is underway to explore an option that employs hyper-linking. • Prior to implementing eDrug Listing an electronic request for a labeler code and e-Registration must be completed • When using SPL r4, Drug Listing must be executed promptly to ensure that labeling is posted to the Daily Med site in the time frame required. * Does not apply to OTC or Vet meds plb 8/2008 v6

2. Submission: SPL(r3); Product Listing: Paper ELIPS NCE, PAS CBE Annual Report Sponsor Initial SPLr3 (COL) Initial SPL r3 (COL) Final SPLr3 (COL) Paper Drug Listing Initial SPLr3 (COL) Final SPLr3 (COL) Paper Drug Listing Paper Drug Listing Process Process FDA EDR EDR EDR EDR Review and respond EDR Paper ELIPS Paper Paper Review and respond ELIPS ELIPS Application process Drug Listing process Application process Drug Listing process Drug Listing process Application process Public Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med plb 8/2008 v6

3. Submission: SPL(r4); Product Listing: Electronic-phase 1 EDR EDR EDR EDR EDR Labeling on facts@FDA* Labeling on facts@FDA* Labeling on facts@FDA* Labeling on facts@FDA* Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Annual Report NCE and PAS CBE Sponsor Initial SPL r4 (CoL) Final SPLr4 (CoL) Final SPLr4 (CoL) Initial SPL r4 (CoL) Initial SPL r4 (CoL) Final SPLr4 (CoL)** Final SPLr4 (CoL)** Initial SPL r4 (CoL) Initial SPL r4 (CoL) Gateway Gateway Gateway Gateway Process Process FDA ELIST ELIST ELIST ELIST Review and respond Review and respond Drug Listing process Drug Listing process Drug Listing process Drug Listing process Application Process Application process Application process Public **Submission of final SPL COL needed only if there are revisions to the originally implemented/submitted CoL. *Site under development plb 8/2008 v6

4. Submission: SPL(r4); Product Listing: Electronic-phase 2 Hyperlink’ EDR EDR EDR EDR EDR Labeling on facts@FDA* Labeling on facts@FDA* Labeling on facts@FDA* Labeling on facts@FDA* Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Annual Report NCE and PAS CBE Sponsor Final SPLr4 (CoL) Initial SPL r4 (CoL) Initial SPL r4 (CoL) Initial SPL r4 (CoL) Final SPLr4 (CoL)** Hyperlink’ ** Initial SPL r4 (CoL) Hyperlink’ Gateway Gateway Gateway Gateway Process Process FDA ELIST ELIST ELIST ELIST Review and respond Review and respond Drug Listing process Drug Listing process Drug Listing process Application process Application process Drug Listing process Application Process Public ‘ Process under development * Site under development ** Submission of final SPL COL needed only if there are revisions to the originally implemented/submitted CoL. plb 8/2008 v6