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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

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Process for submission and drug listing rx human drugs
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


Process for submission and drug listing rx human drugs

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


Process for submission and drug listing rx human drugs

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


Process for submission and drug listing rx human drugs

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