Supporting State Distributor License Validation
To help reduce the compliance burden for users and organizations, State Distributor license information can be automatically validated when users capture an HCP’s signature. Some states require an additional State Distributor license for businesses that store and distribute certain pharmaceutical products.
State Distributor licensing validation eliminates the need for users to manually input and check additional license information for storing and distributing dangerous products in states where State Distributor licensing is required. This feature also supports validation for full or limited Terminal Distributor of Dangerous Drugs (TDDD) licenses, as required by the state of Ohio for businesses storing and distributing certain products. See Ohio TDDD Licensing for more information.
Validation Disclaimer
Call Sampling features are released without validation. Call Sampling requires enablement and does not affect other Vault CRM functionality. Call Sampling features were extensively tested by our QA team during the development and release process and will go through validation at a later date.
Who can use this feature?
- iPad, iPhone Users (Browser, Windows coming soon)
- Users do not require an additional license
- End Users
Configuring State Distributor License for
Business Admin Users
To configure this feature for business admins:
- Ensure the following configuration is complete:
- Navigate to Admin > Users & Groups > Permission Sets > Objects.
- Select the appropriate permission set.
- Grant business admins the following permissions:
Object Object Permission Object Types Field Field Permission address__v
n/a
n/a
- state_distributor__v
- state_distributor_expiration_date__v
- state_distributor_status__v
- state_distributor_category__v
- state_distributor_license_exempt__v
Edit
call2__v
n/a
n/a
- state_distributor__v
- state_distributor_expiration_date__v
- ship_state_distributor__v
- ship_state_distributor_expiration_date__v
Edit
content_acknowledgement__v
n/a
n/a
ship_state_distributor__v Edit
product__v
n/a
n/a
state_distributor_category__v Edit
samples_state_settings__v
CRE
n/a
- external_id__v
- state_distributor_required__v
Edit
sample_transaction__v
n/a
n/a
- state_distributor__v
- state_distributor_expiration_date__v
Edit
sample_order_transaction__v
n/a
n/a
- ship_state_distributor__v
- ship_state_distributor_expiration_date__v
Edit
- Add the state_distributor_category__v field to the appropriate layouts on the product__v object.
- Add the following fields to the appropriate layouts on the samples_state_settings__v object:
- name__v
- state_distributor_required__v
End Users
To configure this feature:
- Ensure the following configuration is complete:
- Configuring Call Sampling
- Configuring Products for Call Sampling
- Configuring Sample Requests (BRCs), if using BRCs
- If users disburse sample-type products, ensure Selecting the Call Location is enabled
- If users disburse BRCs, ensure Shipping Sample Requests (BRCs) to Business Locations is enabled. The Ship to Location section attribute must be on the call2__v layout.
- Navigate to Admin > Users & Groups > Permission Sets > Objects.
- Select the appropriate permission set.
- Grant end users the following permissions:
Object Object Permission Object Types Field Field Permissions address__v
n/a
n/a
- state_distributor__v
- state_distributor_expiration_date__v
- state_distributor_status__v
- state_distributor_category__v
- state_distributor_license_exempt__v
Read
call2__v
n/a
n/a
- state_distributor_expiration_date__v
- ship_state_distributor__v
- ship_state_distributor_expiration_date__v
Read
content_acknowledgement__v
n/a
n/a
ship_state_distributor__v Read
product__v
n/a
n/a
state_distributor_category__v Edit
samples_state_settings__v
R
n/a
- external_id__v
- state_distributor_required__v
Read
sample_transaction__v
n/a
n/a
- state_distributor__v
- state_distributor_expiration_date__v
Edit
sample_order_transaction__v (optional; for BRCs)
n/a
n/a
- ship_state_distributor__v
- ship_state_distributor_expiration_date__v
Edit
- Grant users View permission to the state_distributor__v object control on the call2__v object.
- Navigate to Admin > Configuration > Objects > address__v > Layouts.
- Add the following fields to the appropriate business account layouts on the address__v object (optional):
- state_distributor__v
- state_distributor_expiration_date__v
- state_distributor_status__v
- state_distributor_category__v
- state_distributor_license_exempt__v (can be added to the business account or person account’s layout)
- Populate the state_distributor_category__v field with the appropriate category information for all product records. This is required for any product distributed in a state that requires State Distributor licenses.
- Populate the State Distributor license fields on the address records for all business accounts in states requiring State Distributor licenses. If State Distributor licensing is not required for a particular address, select the state_distributor_license_exempt__v check box on the address record.
Exempt status does not apply for Category 03 products or controlled substances. For those products, State Distributor validation occurs regardless of whether the state_distributor_license_exempt__v check box is selected.
For more information on exemptions, see Possible Exemptions for State Distributor License Validation.
- Populate the allowed_products__v field on the tsf__v object with a list of products allowed at each specific territory and account combination, if the organization has a limited license for Ohio TDDD sampling (optional). For more information on allowed products, see Defining Allowed Products.
- Create a VMOC for the samples_state_settings__v object for all desired offline platforms.
Defining States Requiring State Distributor Licenses
Administrators must create a Sample State Settings record for each state that requires State Distributor licensing:
- Navigate to Business Admin > Objects.
- Create a record on the samples_state_settings__v object for each appropriate state.
- Select the state_distributor_required__v check box and complete the appropriate fields.
Ensure the cds_required__v check box is not selected, and do not populate the settings__v field.
Possible Exemptions for State Distributor License Validation
State Distributor License validation may not apply under certain circumstances in the state of Ohio, including:
- Products that are Category 01 or 02 distributed to businesses owned only by a licensed practitioner or licensed practitioners
- Products distributed to a federal facility
See appropriate state regulations for more information; for example, Ohio TDDD Licensing.
Using State Distributor License Validation as
End Users
See the following sections for details on sampling with state distributor license validation:
- Capturing Sample Disbursements with State Distributor License
- Capturing Sample Requests/BRCs with State Distributor License
- Validating State Distributor Licenses
- Saving and Submitting Calls with State Distributor License
Capturing Sample Disbursements with State Distributor License
If the account address is eligible for the selected products, users capture the sample disbursement as usual. The account’s State Distributor license number displays on the signature capture page. Additionally, if the ship_state_distributor__v field is populated on an Acknowledgement of Content (AOC) record, the State Distributor license number displays on the AOC signature page.
The HCP’s address and the Call Location address must be an exact match for State Distributor license validation.
If users do not have edit field permission for the state_distributor_category__v field on the product__v object, and disburse samples or BRCs in a state requiring state distributor license validation, the following defaults apply to ensure sample and BRC products are disbursed only to eligible HCPs, regardless of Vault configuration:
- Samples and BRCs with the Controlled Substance flag checked are considered Category 03 products for addresses in Ohio
- Samples and BRCs where Controlled Substance flag is not checked are considered Category 02 products for addresses in Ohio
Capturing Sample Requests/BRCs with State Distributor License
When users create sample requests/BRCs on the call report, the ship_to_address__v field does not display invalid addresses. The picklist only displays shipping addresses that have valid State Distributor license information or are exempt from State Distributor license requirements.
If sample requests/BRCs are selected on the call report, the ship_state_distributor__v field displays the account’s State Distributor license number on the signature capture page.
Validating State Distributor Licenses
When capturing a signature on a call report in a state where a distributor license is required, as long as either the HCP or HCO are not exempt, the following validation occurs on the specified location's address record:
|
Field |
Criteria |
|---|---|
|
state_distributor__v |
Must be populated |
|
state_distributor_expiration_date__v |
Must be greater than the current date |
|
state_distributor_status__v |
Must be valid |
|
state_distributor_category__v |
Must contain a match for the selected products’ category, as defined in the state_distributor_category__v field on the product__v records |
In addition, the call address and call location address selected on the call report must be an exact match. Otherwise, the address cannot be validated and the user cannot capture the HCP signature for sampling. (For information on enabling users to select an address for validation when the HCP and call location address differ, see Selecting an Address for State Distributor License Validation.)
If users select an address with 12 or 13 listed in the state_distributor_category__v field, detailing and sampling are limited to allowed products only. To comply with Ohio’s TDDD policies for HCOs with Category 12 or 13 limited licenses, validation ensures the selected product is listed in the allowed_products__v field on the TSF__v object. Category 12 or Category 13 limited licenses enable HCOs to store and handle specific dangerous products, in contrast with the full Category 02 or Category 03 licenses.
If validation fails for any of these fields, an error displays and users cannot capture HCP signatures or submit the call.
If the No Sample License, No Sample License No Signature, or Non-PDMA Sampling section attributes are on the call2__v layout, State Distributor licenses are not validated.
Saving and Submitting Calls with State Distributor License
When users save or submit a call report for an HCP at an address with State Distributor License Information, the values in the state_distributor__v and state_distributor_expiration_date__v fields copy to the following locations:
- call2__v record:
- For samples, the two fields copy to the state_distributor__v and state_distributor_license_expiration__v fields
- For BRCs, the two fields copy to the ship_state_distributor__v and ship_state_distributor_license_expiration__v fields
- sample_transaction__v record (for Samples)
- sample_order_transaction__v record (for BRCs)
If sample_transaction__v or sample_order_transaction__v records containing State Distributor licensing information are unlocked and modified after being submitted, changes to the following fields are recorded in the Vault audit trail for the object:
- Samples – changes to state_distributor__v and state_distributor_license_expiration__v fields are recorded in the audit trail for the sample_transaction__v object
- BRCs – the ship_state_distributor__v and ship_state_distributor_license_expiration__v fields are recorded in the audit trail for the sample_order_transaction__v object
