How to Fill out your Wholesale Distributor/3PL Annual Report to the FDA

From our latest post titled “Wholesale Distributor Annual Reporting Deadline” where we go over the deadline of reporting the necessary information to the FDA on March 31st. We have gotten swamped with request on how to actually fill out the form. We at TrackTraceRx have decided to publish a step-by-step guide.

Step 1.

Visit the login portal: https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:17509663700106:::::

Below you will see the FDA CDER portal. (click to enlarge) Chances are you probably won’t have an account yet. Click on the Create Account link.


Screen Shot 2015-03-30 at 11.24.53 AM

Step 2.

Register for an account. https://direct.fda.gov/apex/f?p=100:5:17509663700106::NO:::

Fill out your company information that is appropriate. You will need a DUNS number to proceed. You can get a free DUNS number at http://dnb.com/. Select the WDD/3PL check box and click submit. Momentarily the FDA will send you your CDER number and credentials on your email.

Screen Shot 2015-03-30 at 11.30.12 AM

Step 3.

Visit again the login portal: https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:17509663700106:::::

Type in your credentials and hit login.

Screen Shot 2015-03-30 at 11.38.32 AM

Step 4.

Once logged in, you will be able to see any previous submittal. Click on the WDD/3PL link.

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Step 5.

Next, you will select “Create a new WDD/3PL using a blank form. Click “continue”.

Screen Shot 2015-03-30 at 11.10.31 AM

Step 6.

You will now be in the SPL submission section. Fill out the appropriate information and click “Save Draft”. Once a draft is saved, you need to add a facility. Click the “Add a Facility” button in the bottom.

Screen Shot 2015-03-30 at 11.10.42 AM

Step 7.

You will now be able to add multiple of your facilities. Fill out the appropriate information. Add any different trade names per facility and select if it is a WDD or 3pl. Click “Save Facility” at the top right.

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Step 8.

Once the facility has been saved, you can add additional ones or click “Submit SPL”.

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Step 9.

Once submitted, you should see your annual report submittal.

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