You can use a Compliance Package binder and connected promotional pieces to generate an FDA Form 2253 from within Vault. The form auto-populates using field values from the binder and from connected documents. This feature can also generate continuation pages for the form if the Compliance Binder includes more than eight promotional pieces. With the correct configuration, Vault can generate the supplementary sheet required for multi-product 2253 submissions. Please note that XFA form mapping must be used in order to utilize the FDA’s new 2253 form. This feature must be enabled by an Admin.
Note that this article only applies to the existing Compliance Package functionality. To comply with FDA guidelines on Post Marketing 2253 and Pre Clearance (APLB and OPDP) Submissions for June 2021, Admins must configure the Post Marketing and Pre Clearance Compliance Packages. Users can then generate Post Marketing and Pre Clearance Compliance Packages based on FDA guidelines released in June 2019.
Note: This feature is available to all PromoMats customers, but requires configuration by Managed Services.
How to Generate Compliance Packages with Bulk Actions
You can use a bulk document action to create a compliance package binder, add documents, and generate FDA Form 2253 as a single action. To do this:
- Select the promotional materials documents that will belong to the compliance package binder using the standard process for bulk document actions. Note that you do not need to select reference documents. See details on the selection process.
- From the Choose Action page (Step 2), select Create Compliance Package Binder. To check if you have the correct permissions on the selected documents, click Calculate Permissions.
- Click Next.
- On the Create Compliance Package page (Step 3), select a binder template. See details on the templates below.
- Populate fields for the new binder. Required fields appear with a yellow background. The product you select should be the primary brand. To make selection easier, you can set the Limit to products on selected documents checkbox, which will filter the list to only those selected on at least one of the documents in the bulk action. Select United States as the Country.
- Click Next.
- From the Confirmation page (Step 4), review the summary of changes.
- Click Finish. Vault will send you an email with details of the changes once the bulk action is complete.When this action is complete, there will be a new binder with all the documents selected in Step 1 and a new PDF document with the Health Authority Form document type.
How to Generate Form 2253 from a Binder
To generate a Health Authority Form 2253:
- Create a binder with the document type Compliance Package.
- Select a single product for the binder.
- If Vault uses the Country object, select US.
- Add documents to the binder. These documents should have the same product as the binder.
- From the Actions menu, select Generate 2253.
- Vault will start the generation process and send an email notification when it is complete.
- Once completed, the Form 2253 (PDF) is saved as a new Health Authority Form document in the binder.
Criteria for 2253 Generation
In order to generate a Health Authority Form 2253, the binder must meet these conditions:
- For Vaults that use the Country object, the selected country must be United States for the Compliance Package binder. Vaults that do not use the country object do not include this restriction.
- The binder’s document type is Compliance Package.
Vault does not confirm that there are Promotional Piece documents in a binder before allowing you to generate a form, so you can create an incomplete form.
Steady State Validation
Admins can configure your Vaults to prevent non-steady state promotional content from being added to a compliance package.
Note: Steady State is only enforced on documents included in the compliance package. Enforce Documents are in a Steady State check does not perform a check for documents added after the Generate Compliance Package bulk action, such as labeling and Form 2253.
To enable this:
- Navigate to Admin > Settings > Application Settings.
- In the Compliance Package Generation section, select Enforce Documents are in Steady State.
This prevents users from completing the Generate Compliance Package bulk action if all included documents are not in a Steady state.
Optionally, configure the Set binder content version binding to Steady State entry action. This feature automatically sets binding rules on binder content to bind to the latest Steady state content.
You can use the Generate 2253 action as many times as necessary. Each time, Vault creates a new version of the existing form.
You cannot version if:
- The binder contains more than one Health Authority Form document.
- The existing Health Authority Form document is checked out (locked).
Multi-Product 2253 Generation
If your Vault uses multi-product 2253 generation, the product field mapped to the form’s Secondary Brands field will auto-populate with all product values other than the one selected as the binder’s product.
- Vault does not confirm that there are Promotional Piece documents in a binder before allowing you to generate a form, so you can create an incomplete form.
- Vault will ignore any documents in a binder that are not for the same product as the binder when generating a form. Documents can have multiple products selected, but one must be the same product as the binder.
- If rendering a populated 2253 form fails, Vault will try to generate an XML file with all of the data that would be in the 2253 form. You can then download the XML file and manually import it into a 2253 form using Adobe® Acrobat® Professional.
- When generating a 2253 form using XFA Form Mapping, Vault orders documents by Document Number (Material ID), first numerically and then alphabetically.
To generate Form 2253 and work with generated forms, you should have the following permissions. If your Vault uses the XFA form generation feature, you’ll also need the permissions listed for that.
|Security Profile||Application: Library: Bulk Update||Ability to access the Generate Compliance Package action|
|Document Type: Compliance Binder||Create Binder||Ability to successfully complete the G_enerate Compliance Package_ action|
|Document Type: Health Authority Form||Create Document||Ability to successfully complete the Generate Compliance Package action|
|Document Role||View Document||On binder component documents: Ability to select documents for the Generate Compliance Package action
On Compliance Package binder: Ability to view the binder
On generated Form 2253: Ability to view the generated form
|Document Role||Version||Allows you to generate an update to the Health Authority Form document if it’s in Steady state|
|Document Role||Edit Document||Allows you to generate an update to the Health Authority Form document if it’s in any state other than the lifecycle’s Steady state.|
Generated Form & Field Mapping
Every field on the generated Form 2253 maps to a field on the binder, on the binder’s component documents, or on an object record referenced by the binder. However, these mappings vary between Vaults. Contact your Vault administrator for information on your Vault’s field mappings.
If documents in your Compliance Package binder include Linked Documents relationships to documents with the Prescribing Information subtype, Vault adds the related documents to the binder in a separate section for references. The Prescribing Information documents linked to the binder are bound to the version currently in use. You must have permission to the Prescribing Information documents for this to occur.
Vault provides standard binder templates for the Compliance Package document type:
- Compliance Package Template/Offline Submission Compliance Package: This template provides a generic way to collect documents included in a submission.
- eCTD Compliance Package: This binder template is based on the FDA’s latest guidance for eCTD Module 1 submission.
Default Vault Objects and Fields for 2253 Generation
New Vaults provisioned after V15 are automatically configured with the required fields, objects, and mappings. However, there are a number of features that can be enabled for existing Vaults to auto-provision the required fields and objects for mapping to the Form 2253.
The table below describes some of the differences between the fields provided by default prior to V15 and post-V15:
|2253 fields||Prior to V15||V15 and later|
|Product||Manual entry||Manual entry|
|Secondary Brands||Not available
Single product 2253 generation only
|Automatically populated through Create Compliance Package bulk action
Can be edited manually
|Application Type||Manual entry||Inferred from Product
Binder field should be hidden
|Application Number||Manual entry||Inferred from Product
Binder field should be hidden
|Applicant||Manual entry||Inferred from Application
Binder field should be hidden
The details exist as part of the selected Applicant
Allows the appropriate Responsible Official to be selected
The V15 default configuration is necessary for the 2253 Supplementary Sheet to be populated correctly. For each secondary brand (product values), the Application Type and Application Number must be listed, so there must be a link between Product and Application.