Source: https://vaultcrmhelp.veeva.com/doc/Content/CRM_topics/CallSampling/SamplingRegReq/ValidatingSDL.htm ## 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](https://pharmacy.ohio.gov/Licensing/TDDD.aspx) 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?** * End Users — Browser, iPad, iPhone, Windows * [Capturing Sample and BRC Disbursements with State Distributor License](#Capturin) * [Saving and Submitting Calls with State Distributor License](#Saving) * Users do not require an additional license ### Configuring State Distributor License for [![Closed](../../../../Skins/Default/Stylesheets/Images/transparent.gif)Business Admin Users](#) To configure this feature for business admins: 1. Ensure the following configuration is complete: * [Configuring Call Sampling](../Config/ConfiguringCS.htm) * [Configuring Products for Call Sampling](../Config/ConfiguringProductsCS.htm) * [Configuring Sample Requests (BRCs)](../Config/ConfiguringBRCs.htm), if using BRCs 2. Navigate to **Admin > Users & Groups > Permission Sets**. 3. Select the appropriate permission set. 4. Select the **Objects** tab. 5. 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 | 6. Navigate to **Admin > Configuration > Objects > product\_\_v > Layouts**. 7. Add the **state\_distributor\_category\_\_v** field to the appropriate layouts on the product\_\_v object. 8. Navigate to **Admin > Configuration > Objects > **samples\_state\_settings\_\_v** > Layouts**. 9. Add the following fields to the appropriate layouts on the **samples\_state\_settings\_\_v** object: * name\_\_v * state\_distributor\_required\_\_v [![Closed](../../../../Skins/Default/Stylesheets/Images/transparent.gif)End Users](#) To configure this feature: 1. Ensure the following configuration is complete: * [Configuring Call Sampling](../Config/ConfiguringCS.htm) * [Configuring Products for Call Sampling](../Config/ConfiguringProductsCS.htm) * [Configuring Sample Requests (BRCs)](../Config/ConfiguringBRCs.htm), if using BRCs * If users disburse sample-type products, ensure [Selecting the Call Location](../../Call_Reporting_2/Executing/PopulateHeader/CallLocation.htm) is enabled * If users disburse BRCs, ensure [Shipping Sample Requests (BRCs) to Business Locations](../ShipBRC/ShipToBusiness.htm) is enabled. The Ship to Location section attribute must be on the call2\_\_v layout. 2. Navigate to **Admin > Users & Groups > Permission Sets**. 3. Select the appropriate permission set. 4. Select the **Objects** tab. 5. 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 | 6. Grant users View permission to the **state\_distributor\_\_v** field control on the call2\_\_v object. 7. Navigate to **Admin > Configuration > Objects > address\_\_v > Layouts**. 8. 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) 9. Navigate to **Business Admin > Objects**. 10. 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. 11. 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** checkbox 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 checkbox is selected. For more information on exemptions, see [Possible Exemptions for State Distributor License Validation](#Exemptions). 12. Populate the **allowed\_products\_\_v** field on the appropriate tsf\_\_v records 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](../../Call_Reporting_2/Restrictions/AllowedProd.htm). 13. 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: 1. Navigate to **Business Admin > Objects**. 2. Create a record on the **samples\_state\_settings\_\_v** object for each appropriate state. 3. Select the **state\_distributor\_required\_\_v** checkbox and complete the appropriate fields. Ensure the cds\_required\_\_v checkbox 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](https://pharmacy.ohio.gov/Licensing/TDDD.aspx). ### Capturing Sample and BRC Disbursements with State Distributor License as [![Closed](../../../../Skins/Default/Stylesheets/Images/transparent.gif)End Users](#) 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](../ShipBRC/CaptureAOC.htm) (AOC) record, the State Distributor license number displays on the AOC signature page. ![](../../../Resources/Images/SampleManagement/Advanced/SDLSigCap.PNG) The HCP’s address and the Call Location address must be an exact match for State Distributor license validation. If users do not have Read 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 When users [create sample requests/BRCs](../Disbursements/CreateBRC.htm) 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. ![](../../../Resources/Images/SampleManagement/Advanced/SDLShipBRC.PNG) 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. ![](../../../Resources/Images/SampleManagement/Advanced/SDLBRCSigCap.PNG) #### 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](ValidatingSDLwithLocation.htm).) 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](../../Call_Reporting_2/Restrictions/AllowedProd.htm) 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 as [![Closed](../../../../Skins/Default/Stylesheets/Images/transparent.gif)End Users](#) 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 ### Related Topics [Displaying the State Distributor License Status Indicator](SDL_Indicator.htm) [Selecting an Address for State Distributor License Validation](ValidatingSDLwithLocation.htm) [Enabling Controlled Substance Sampling](EnablingCS.htm)