How Do I...

1. From the 340B Home Page, either:

   • Click the I am a Participant A registered entity or facility in the 340B program. icon OR
   • Click the Login link in the top menu.
2. Click the Create new account link.
3. On the Create a New User email search page, type your email address and click Search.

4. On the Create a New User registration page, enter your name, title, organization name (employer), and phone number.

   If your email address is associated with a covered entity, the system will enter your contact information automatically.

5. Select the your parent entity type (Covered Entity or Manufacturer).
6. Type your password and then type it again to confirm it.
7. Type the CAPTCHA Acronym for "Completely Automated Public Turing test to tell Computers and Humans Apart," a type of challenge-response test used in computing to determine whether or not the user is human. code.
8. Click the Register button.
9. The system will display a message that your account was created successfully.
10. Click Return to Login to go to the login page.

For complete information, see Creating an Account.

1. Click on your user name on the right side of the 340B top menu and select Edit Profile.

2. On the My Profile page, make any necessary changes to your first or last name, title, organization, phone number, or phone extension.

   You cannot change your email address because it is also your 340B user name. If you must change your email address, you must create a new account and update any entities with which you are associated.

3. Click the Update button. The My Profile page will display the message "User updated successfully."

For complete information, see Editing Your Profile.

1. From the 340B Home Page, either:

   • Click the I am a Participant icon OR
   • Click the Login link in the top menu.
2. On the 340B login page, click the Recover Your Account link.
3. On the Forgot Your Password? page, enter your email address and click the Reset Password button.
4. Check your email for a Reset Password Request email and click the password reset URL.
5. On the Reset Password page, enter and confirm your new password.

6. Log in as usual using your new password.

   Passwords may only be changed once within a 24-hour period.

For complete information, see Resetting Your Password.

You do not need to be logged into the 340B application to perform searches.

1. From the 340B Home Page, either:

   • Click the Search icon and then click the Covered Entities button on the next screen.

     OR

   • Click the Search link in the top menu and select Search Covered Entities.

2. On the Search Criteria page, use the available criteria to narrow your search results to a manageable number of entities.

   • Keyword – the text for which you want to search
   • 340B ID A unique identification number assigned by OPA to each covered entity parent or child site (e.g., child site, subdivisions, or sub-grantees). – only a specified entity and any child entities
   • City / State / ZIP Code – only entities in a specific location
   • Entity Name – only entities with a specific sequence of characters in their names

   • Advanced Query Options – only entities that will be added or terminated this quarter or next quarter.

     • Start Date Denotes an entity's start date in the 340B program. Entity start dates are updated quarterly. (from/to) – limit search to specific date range (automatically populated for the current or next quarter when either "Entities To Be Added…" option is selected)
     • Termination Date The date in the 340B OPAIS on which a provider's participation in the 340B program is terminated. After its termination date, a provider can no longer purchase 340B drugs. OPA updates termination dates on a quarterly basis. (from/to) – limit search to specific date range (automatically populated for the current or next quarter when either "Entities To Be Added…" option is selected)
   • Entity Classification – only hospitals, only non-hospitals, or all entities
   • Grant Financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. / Provider Number – only a specific entity or grant (entering a hospital's Medicare Provider Number will display the parent hospital and all of its outpatient facilities).
   • Site ID – only specific HRSA Funded Health Center (CH) and Health Center Program Look-Alike (FQHCLA) programs
   • Participating – only active covered entities, all covered entities, or only terminated entities and approved entities with a future participation date
   • Edit Date The 340B OPAIS uses the term "edit date" to denote the date that a 340B entity's information was edited. Edits can occur at any time. (from/to) – only entities edited during a specific date range
   • Registration Date (from/to) – only entities edited during a specific date range

3. Click the Search button to display the results. The system will display a list of entities that match your search criteria.

   • To view the details for a particular entity, click its link in the 340B ID column.

For complete information, refer to Covered Entities.

You do not need to be logged into the 340B application to perform searches.

1. From the 340B Home Page, either:

   • Click the Search icon and then click the Contract Pharmacies button on the next screen.

     OR

   • Click the Search link in the top menu and select Search Contract Pharmacies.

2. On the Search Criteria page, use the available criteria to narrow your search results to a manageable number of entities.

   • 340B ID – only a specified entity and any child entities
   • Entity Name – only entities with a specific sequence of characters in their names
   • Entity City / State / Zip – only entities in a specific location
   • Pharmacy Name – only entities with a specific sequence of characters in their names
   • Pharmacy City / State / Zip – only pharmacies in a specific location

   • Advanced Query Options – only contracts that will be added or terminated this quarter or next quarter.

     • Begin Date From/To) – limit search to specific date range (automatically populated for the current or next quarter when either "Contracts Added…" option is selected)

     • Termination Date From/To) – limit search to specific date range (automatically populated for the current or next quarter when either "Contracts Added…" option is selected)
   • Edit Date (from/to) – only pharmacies edited during a specific date range
   • Carve-In Section 340b(a)(5)(A)(i) of the Public Health Service Act prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts. Carving-in describes a covered entity's decision to use 340B drugs for its Medicaid patients. Upon enrollment in the 340B Program, covered entities that decide to carve-in must provide their Medicaid provider number or National Provider Identifier (NPI) at the time they enroll. OPA lists this information in a Medicaid Exclusion File posted on its website. Having this information in the file indicates to the states and manufacturers which drugs are not subject to Medicaid rebates, and helps ensure the prevention of duplicate discounts, as prohibited by statute. Covered entities are required to ensure that information in the file is accurate each quarter and at the time of annual recertification. Date (from/to) – specific date range when the associated covered entity informed HRSA of an arrangement with the listed contract pharmacy and respective state Medicaid agency to prevent duplicate discounts
   • Search Carve-Ins – select checkbox to return only covered entities that have informed HRSA of an arrangement with the listed contract pharmacy and respective state Medicaid agency to prevent duplicate discounts

3. Click the Search button to display the results. The system will display a list of contract pharmacies that match your search criteria.

   • Click the link in the Contract Detail column to view the details for a contract.

   • Click the entity's name in the 340B ID column to view the details for a covered entity.

   • Click the pharmacy's name in the Pharmacy Name column to view the details for a pharmacy.

For complete information, refer to Contract Pharmacies.

You do not need to be logged into the 340B application to perform searches.

1. From the 340B Home Page, either:

   • Click the Search icon and then click the Manufacturers button on the next screen.

     OR

   • Click the Search link in the top menu and select Search Manufacturers.

2. On the Manufacturer Search Criteria page, use the available criteria to narrow your search results to a manageable number of manufacturers.

   • labeler code – only the FDA-assigned labeler codes that match the specified sequence of digits
   • Status – labeler codes that are active, inactive, or both
   • Manufacturer Name – only manufacturers with a specific sequence of characters in their names
   • City / State / Zip – only manufacturers in a specific location
   • Signed Date (from/to) – only manufacturers approved for participation during a specific date range
   • EditDate (from/to) – only manufacturers whose records were edited during the specified date range
   • OPA Termination Date (from/to) – only manufacturers terminated from the 340B Program The federal drug discount program authorized under section 340B of the Public Health Service Act and established by Congress under the Veterans Health Care Act of 1992 (Public Law 102-585, codified at 42 USC § 256b). The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices. during the specified date range
   • OPA Termination Date (From/To) – only manufacturers terminated from the CMS Centers for Medicare and Medicaid Services, the federal agency within Health and Human Services (HHS) that administers the Medicare and Medicaid programs, including the Medicaid drug rebate program and the Medicare Part D prescription drug benefit. Medicaid Drug Rebate Program during the specified date range

3. Click the Search button to display the results. The system will display a list of labeler codes that match your search criteria.

   • Click the link in the labeler code column to view the details for manufacturer.

For complete information, refer to Manufacturers.

1. From the 340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA). home page, enter select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.
2. On the Covered Entity Registration page, click the "A Hospital" button.
3. On the Search for Hospital page, enter the MPN for the terminated hospital and click the Search button.
4. On the Register Hospital page, confirm the hospital name, street address, entity type, and current 340B status.

5. Under "What would you like to do?" select:

   • Register for the 340B program as the entity type listed above to register the entity as the same type.

   • Register as a different entity type to register as a different entity type, and select the new entity type.

     Refer to Changing the Hospital Type during Registration for more information.

6. On the Covered Entity Details page:

   • Type a new EIN if one has been assigned by the IRS.
   • Uncheck the "Billing Address An address verified as belonging to the covered entity that is used for billing purposes. A billing address is not required to be a physical address; it can be a P.O. box or other mailing address. Same as Street Address" box if you want to have bills for 340B drug purchases sent to a different address than the hospital street address.

   • Uncheck the "Shipping Address An address authorized to receive 340B drugs on behalf of a covered entity parent or child site and registered as such on the 340B OPAIS. Because pharmacies are not permitted to be registered as covered entity sites, they may be listed as shipping addresses of the parent entity or a registered outpatient child site, depending on the locations served by the pharmacy. When registering a new covered entity or a new outpatient facility online, the entity has a choice of listing shipping addresses under either the main entity's registration or the offsite facility's registration. Listing shipping addresses permits all parties to know where 340B drugs may be delivered by the manufacturer and wholesaler. Pharmacies that support multiple outpatient facilities should be listed as shipping addresses under the parent entity. Same as Street Address" box if you want to have 340B drugs sent to a different address than the hospital street address.

     PO boxes and contract pharmacies are not allowed as shipping addresses.

7. On the Contact Information page, confirm and update the AO and PC External user who is designated as a Primary Contact for an entity. This user can enter registrations and update entity information. This user can enter registrations, and update entity information. Any changes to an entity performed by the PC user must be attested to by the AO for that entity. information for the entity.

   • You must be logged in as either the Authorizing Official or the Primary Contact.
   • The PC may not be the same person as the AO.

8. As appropriate for the hospital type, the Qualification Information page will display the most recent data available from CMS data sources and cost reporting period from which that data originated. You may change any data that is incorrect or out of date.

   • You must select the checkbox at the top of the page to that the hospital meets the qualifications for that hospital type as defined by the Social Security Act and that it is recognized by CMS or you will not be able to proceed.

   • If you change the DSH percentage (all hospital types except CAH) or the cost reporting dates, you must submit Medicare cost report worksheets and a working trial balance to OPA for review.
   • The Filing Date The date when the Cost Center report was filed (required field for all hospital registrations). This date must be (1) greater than the cost reporting period end date, (2) not older than a year, and (3) not a future date./Calculation Date must be greater than the Cost Reporting Period end date and not more than a year in the past.
   • For-profit hospitals are not eligible to participate in the 340B program.

   • If the hospital classification is "Private, Non-Profit Hospital with State/Local Govt contract," the contract dates are required.

9. On the Medicaid Billing page, answer whether Medicaid will be billed for 340B purchased drugs (defaults to No).

   • If you select Yes you must enter at least one Medicaid Provider Number and state or National Provider Identifier (NPI) A unique 10-digit identification number for covered health care providers. Health care providers, all health plans, and health care clearinghouses must use the NPIs in the administrative and financial transactions adopted under HIPAA. number.

10. On the Statutory Prohibition on Group Purchasing Organization Participation page, select the checkbox to confirm that the hospital will not obtain covered outpatient drugs through a group purchasing organization (GPO).

    This section only appears for DSH, PED, and CAN hospitals. This section will not appear for CAH, RRC, and SCH hospitals.

11. Confirm and submit the registration.

    If you are the AO, the Authorizing Official Signature section will be appended to the bottom of the summary page to allow you to attest to the registration.

For complete information, refer to Hospital Registration.

1. From the 340B OPAIS home page, enter select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.
2. On the Covered Entity Registration page, click the "A Hospital" button.
3. On the Search for Hospital page, enter the MPN for the terminated hospital and click the Search button.
4. On the Register Hospital page, confirm the hospital name, street address, entity type, and current 340B status.

5. Under "What would you like to do?" select the Register Outpatient Facilities option and click the Continue button.

   Outpatient facilities may be registered while the parent hospital is still pending OPA approval.

6. On the Covered Entity Outpatient Facility Search Results page, select the checkbox for the outpatient facility to be registered.

   • If the desired facility does not appear in the search results, click the Not Found. Add a Facility button.
   • Currently registered outpatient facilities and terminated facilities are listed in the table below the Search Results table. To reinstate a terminated outpatient facility, click its name in the Sub Name column and confirm and update its information as you would for a new registration.
   • Only one cost center line is permitted to be registered by the entity. Each cost center line requires a separate registration.

7. On the Covered Entity Details page, record any additional information for the outpatient facility

   • Type a sub-division name for the outpatient facility that closely reflects the services being provided on the cost center line being registered.
   • Type a new Outpatient EIN if the IRS has assigned one that is different from the parent hospital.
   • Type a new Outpatient Facility Provider Number if different from Medicare Provider Number of the parent hospital.
   • Uncheck the "Billing Address Same as Street Address" box if you want to have bills for 340B drug purchases sent to a different address than the hospital street address.

   • Uncheck the "Shipping Address Same as Street Address" box if you want to have 340B drugs sent to a different address than the hospital street address.

     PO boxes and contract pharmacies are not allowed as shipping addresses.

8. On the Contact Information page, confirm the AO information and add the PC information.

   • You must be logged in as either the Authorizing Official or the Primary Contact.
   • The PC may not be the same person as the AO.

9. The Qualification Information page will display the parent hospital's data. You may update the parent entity's DSH %, cost reporting period, and filing dates, if necessary.

   This information may not be edited if the parent hospital's registration is in "pending" status.

10. In the Cost Center Information section, select a specific cost center line for the facility from the organization's most recently filed Medicare cost report and enter the associated financial information.

    • If the desired cost center is not in the list, select Not Present – Add and enter the required information.
    • If you select a non-patient cost center, you must submit Worksheet A, Worksheet C, and the trial balance from the hospital's latest filed cost report.
    • The Line Number, Subscript, and Description fields are automatically populated based on your selection. Complete the remaining information from your copy of the cost report.

11. On the Medicaid Billing page, answer whether Medicaid will be billed for 340B purchased drugs (defaults to No).

    • If you select Yes you must enter at least one Medicaid Provider Number and state or National Provider Identifier (NPI) number.

12. On the Statutory Prohibition on Group Purchasing Organization Participation page, select the checkbox to confirm that the hospital will not obtain covered outpatient drugs through a group purchasing organization (GPO).

    This section only appears for DSH, PED, and CAN hospitals. This section will not appear for CAH, RRC, and SCH hospitals.

13. Confirm and submit the registration.

    If you are the AO, the Authorizing Official Signature section will be appended to the bottom of the summary page to allow you to attest to the registration.

For complete information, refer to Outpatient Facility Registration.

1. From the 340B OPAIS home page, enter select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.
2. On the Covered Entity Registration page, click the "A Non-Hospital" button.

3. On the Select Non-Hospital page, select the type of non-hospital entity you want to register.

   • For STD and TB entities, the system will prompt whether the organization receives direct grant funding and/or "in-kind" products or services purchased with grant funds. If you select No, the registration cannot proceed.

   • For CH and FQHCLA entities, the system will prompt whether the site is active in HRSA's Electronic Healthbook (EHB) system. If you select No, the registration cannot proceed.

     • On the Search EHB page, select a grant number for a CH entity or a designation number for a FQCHLA entity and click the Search button.
     • On the EHB search results page, select a site with 340B status of "Available" and click the Continue button.

4. The system displays the Covered Entity Details page.

   • Type the entity name (pre-filled for CH and FQHCLA entities).
   • Type the entity's subdivision name (pre-filled for CH and FQHCLA entities).
   • Type a new EIN if one has been assigned by the IRS.

   • As appropriate, select the check boxes for the nature of direct grant funding -- either Direct Funding or "In-Kind" products or services purchased with direct grant funds or both.

     Selecting "None" will uncheck the other boxes (if selected) and make the entity ineligible for registration.

   • Uncheck the "Billing Address Same as Street Address" box if you want to have bills for 340B drug purchases sent to a different address than the hospital street address.

   • Uncheck the "Shipping Address Same as Street Address" box if you want to have 340B drugs sent to a different address than the hospital street address.

     PO boxes and contract pharmacies are not allowed as shipping addresses.

5. On the Contact Information page, confirm and update the AO and PC information for the entity.

   • The PC may not be the same person as the AO.

   • You must be logged in as either the Authorizing Official or the Primary Contact.

6. On the Medicaid Billing page, answer whether Medicaid will be billed for 340B purchased drugs (defaults to No).

   • If you select Yes you must enter at least one Medicaid Provider Number and state or National Provider Identifier (NPI) number.

7. Confirm and submit the registration.

   If you are the AO, the Authorizing Official Signature section will be appended to the bottom of the summary page to allow you to attest to the registration.

For complete information, refer to Non-Hospital Registration.

1. From the Covered Entity Details page for an active entity for which you are the AO or PC, select the Contract Pharmacy tab and click the Add button.
2. Read the contract pharmacy Instructions page and click the Continue button.

3. On the Covered Entity Details page the Associated option is selected by default and the system displays a list of active pharmacy contracts already associated with the entity.

   If the desired pharmacy is not listed, you can search for it using its DEA Number or location.

4. In the Search Results section, select the desired pharmacy and click the Continue button.
5. Enter the pharmacy representative's email address and contact information and click the Submit button.

For complete information, refer to Contract Pharmacy Registration.

1. From the Covered Entity Details page for an active entity for which you are responsible as AO or PC, click the Change Request button.

   • For Outpatient Facilities, the Outpatient Facility Provider Number and Outpatient EIN are also shown if they are different from the parent hospital.

   • For Non-Hospitals, the Grant Number is shown instead of the Medicare Provider Number, if available.

2. The Change Request page will display the entity's entire registration for your review. Click the Edit… link to edit the information for a particular section.

   If the entity is under recertification, only the AO may be changed.

3. Select the Edit Main Details link or the Edit Addresses link to edit the entity's details and address information.

   Hospitals

   • You may change the Entity Name, EIN (if a new one has been assigned by the IRS), and Street Address, if necessary.
   • Uncheck the "Billing Address Same as Street Address" box if you want to have bills for 340B drug purchases sent to a different address than the hospital street address.

   • Uncheck the "Shipping Address Same as Street Address" box if you want to have 340B drugs sent to a different address than the hospital street address.

     PO boxes and contract pharmacies are not allowed as shipping addresses.

   Outpatient Facilities

   • You may change the Entity Subdivision Name, Outpatient EIN (if a new one has been assigned by the IRS), Outpatient Facility Provider Number (if different from parent hospital), and Street Address, if necessary.
   • Uncheck the "Billing Address Same as Street Address" box if you want to have bills for 340B drug purchases sent to a different address than the hospital street address.

   • Uncheck the "Shipping Address Same as Street Address" box if you want to have 340B drugs sent to a different address than the hospital street address.

     PO boxes and contract pharmacies are not allowed as shipping addresses.

   Non-Hospitals

   • Site ID may be added or changed for CH and FQCHLA entities.
   • Nature of Support may be added or changed for STD and TB entities.
   • You may change the Entity Subdivision Name, EIN (if a new one has been assigned by the IRS), Grant Number, and Street Address, if necessary.
   • Uncheck the "Billing Address Same as Street Address" box if you want to have bills for 340B drug purchases sent to a different address than the hospital street address.

   • Uncheck the "Shipping Address Same as Street Address" box if you want to have 340B drugs sent to a different address than the hospital street address.

     PO boxes and contract pharmacies are not allowed as shipping addresses.

4. Select the Edit Contacts link to edit the contact information for the entity's current AO and PC.

   • The Organization name is required. You will not be able to save any changes if it is missing for either the AO or the PC.

   • To change the AO or PC for the entity, click the Please Select Contact drop-down list to search the system for their email address.

5. On the Medicaid Billing page, answer whether Medicaid will be billed for 340B purchased drugs (defaults to No).

   • If you select Yes you must enter at least one Medicaid Provider Number and state or National Provider Identifier (NPI) number.

6. As you make changes to the registration, they will be summarized at the bottom of the page for review before submission.

7. Confirm and submit the registration.

   If you are the AO, the Authorizing Official Signature section will be appended to the bottom of the summary page to allow you to attest to the registration.

For complete information, refer to Requesting Changes to a Covered Entity.

1. From the 340B OPAIS home page, enter select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.

2. On the Covered Entity Registration page, click the "A Hospital" button.

3. On the Search for Hospital page, enter the MPN for the terminated hospital and click the Search button.

4. On the Register Hospital page, confirm the hospital name, street address, entity type, and current 340B status.

5. Under "What would you like to do?" select:

   • Reinstate the selected entity to register the entity as the same type.
   • Register as a different entity type to reinstate as a different entity type, and select the new entity type.
6. Click Continue. The system will display the Covered Entity Details page.
7. Continue according to the instructions for Hospital Registration.

Outpatient facility reinstatements are processed as new registrations.

1. From the 340B OPAIS home page, enter select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.

2. On the Covered Entity Registration page, click the "A Hospital" button.

3. On the Search for Hospital page, enter the MPN for the terminated outpatient facility's parent hospital and click the Search button.

4. On the Register Hospital page, confirm the hospital name, street address, entity type, and current 340B status.

5. Under "What would you like to do?" select Register Outpatient Facilities and click Continue.

6. The system will display the Covered Entity Details page.
7. Select the outpatient facility from the list in the Covered Entity Outpatient Facility Search Results section.
8. Confirm the information for the outpatient facility and update it as appropriate according to the instructions for Outpatient Facility Registration.

1. From the 340B OPAIS home page, enter select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.

2. On the Covered Entity Registration page, click the "A Non-Hospital" button.

3. On the Select Non-Hospital page:

   • Select the covered entity type.
   • Under Would you like to reinstate a previously terminated 340B ID? select Yes.
   • Type the 340B ID for the terminated entity and click the Search button.
   • Click the Continue button.
4. On the Covered Entity Details page, confirm the entity's information update it as appropriate according to the instructions for Non-Hospital Reinstatements.

1. From the 340B home page, select Register > Register Covered Entity and/or Outpatient Facility from the top menu or click the Register Covered Entity icon.
2. On the Covered Entity Registration page, click either the "A Hospital" button or the "A Non-Hospital"button, depending on the type of covered entity you want to register, and proceed with the covered entity registration process.
3. On the Contact Information page, select your own user name as Authorizing Official.

4. Complete the rest of the registration, attest to it, and submit it to OPA for approval.

   • The new registration will appear on your My Dashboard under My Pending.
   • You will receive a Registration Confirmation email.
   • Upon OPA approval, you and the entity's PC will both receive a 340B Participation Approval email and the entity's 340B status will be updated to "Approved."

You must be fully authorized to legally bind the covered entity. All AO change requests must be approved by OPA.

1. Use the Covered Entity Search function to locate the desired covered entity

2. View the CE details and click the Change button for the Authorizing Official.

   The entity's details are displayed with your contact information populated in the Requestor Information section.

3. Attest to the change and submit it to OPA for approval.

For complete information, refer to Requesting to Become the AO of a Covered Entity.

The Office of Pharmacy Affairs (OPA) The HRSA office responsible for administering the 340B program. is required to recertify all participating 340B covered entities annually to ensure that they are eligible to remain in the 340B Drug Pricing Program and that the application is accurate. Recertification 340B covered entities must annually recertify their eligibility to remain in the 340B Program and continue purchasing covered outpatient drugs at discounted 340B prices. As part of this process, the Authorizing Official of each 340B covered entity certifies basic information about the entity and its 340B compliance. Covered entities with inaccurate information in the 340B OPAIS run a high risk of being removed from the program. also gives OPA an opportunity to verify compliance with the program requirements and update the 340B application.

Both the AO and the PC will receive an "Advanced Notification" email when OPA creates a recertification initiative that includes one or more of their active entities. Recertification initiatives will not include terminated entities, entities pending termination, or newly registered entities that have not yet reached their participation start date.

1. On the recertification start date, tasks for entities that need to be recertified will appear in the My Tasks tab of My Dashboard. In the Task column, click the Recertification link for the desired entity.

   • If changes are required, the Recertification Information page will tell you what information must be updated.

   • If no changes are required, the Recertification Information page will display the message "Your information is up to date. Please proceed to Recertification."
2. Click the Continue button.

3. The Covered Entity Details page is displayed.

   • If changes are required, the page will display "Please update…" messages in the headings of sections where information must be updated. You may also update other information in the registration.

     Refer to Change Requests for more information.

   • If no changes are required, no messages will be displayed, but you still may make any other changes you need to.

4. To update required information, click the Edit… link to open an area where the "Please update…" message is displayed. Update the required fields and click the Continue button. Repeat this step for each area where updates are required.

   Before making any changes, click the Continue button. The system will display error messages that identify which required fields must be updated.

Submit Recertification

1. Click the Submit button to submit the recertification.
2. When the system displays the Recertification Submission page, you must click the OK button to complete the recertification and return to your My Dashboard.

Terminate Entity

1. Click the Terminate button if you want to terminate the entity.
2. The system will display a summary of the Covered Entity Details page. In the Termination Information section:
   • The requested termination date will default to the first day of the next quarter.
   • Select a Termination Reason from the drop-down list.
   • Provide the date the entity became ineligible and the last date with drugs were or will be purchased.
   • Type any pertinent comments, if necessary.
3. Click Submit to complete the termination.
4. On the Termination Request Submission page, click the OK button to complete the termination and return to your My Dashboard.

For complete information, refer to Recertification.

1. On the recertification start date, tasks for entities that need to be recertified will appear in the My Tasks tab of My Dashboard. In the Task column, click the Recertification link for the desired entity.

   • If changes are required, the Recertification Information page will tell you what information must be updated.
   • If no changes are required, the Recertification Information page will display the message "Your information is up to date. Please proceed to Recertification."
2. Click the Continue button.

3. The Covered Entity Details page is displayed.

   • If changes are required, the page will display "Please update…" messages in the headings of sections where information must be updated. You may also update other information in the registration (refer to Change Requests for more information).
   • If no changes are required, no messages will be displayed, but you still may make any other changes you need to.

4. To update required information, click the Edit… link to open an area where the "Please update…" message is displayed. Update the required fields and click the Continue button. Repeat this step for each area where updates are required.

   Before making any changes, click the Continue button. The system will display error messages that identify which required fields must be updated.

Submit Recertification

1. In the Authorization Official Signature area, select the checkbox to confirm that you are authorized to legally bind the covered entity and certify that the registration is truthful and accurate.
2. Click the Submit button to submit the recertification.
3. When the system displays the Recertification Submission page, you must click the OK button to complete the recertification and return to your My Dashboard.

Terminate Entity

1. Click the Terminate button if you want to terminate the entity.

2. The system will display a summary of the Covered Entity Details page. In the Termination Information section:

   • The requested termination date will default to the first day of the next quarter.
   • Select a Termination Reason from the drop-down list.
   • Provide the date the entity became ineligible and the last date with drugs were or will be purchased.
   • Type any pertinent comments, if necessary.
3. Select the checkbox to confirm that the contents of the termination request are truthful and accurate
4. Click Submit to complete the termination.
5. On the Termination Request Submission page, click the OK button to complete the termination and return to your My Dashboard.

Refer to Recertification for more information.

1. From the 340B OPAIS home page, select ADR Petitions from the top menu.

2. Select Edit under the Actions column for the ADR Petition that you want to edit.

3. All sections of the Petition are available for update.

4. Provide the information in the sections as required by HRSA.

5. Click on Save Changes to save the petition information.

6. Click on Submit to HRSA for Review after all the needed information has been added to the petition.

The Submit to HRSA for Review button is available only when you submit the ADR Petition to HRSA for review for the first time. After the first submit, the Save Changes button is available to save the updates when you make changes to the ADR Petition. HRSA will be notified automatically of all the changes at the end of the day.