Form 3.1 Contract Pharmacy Registration

Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327

340B Contract Pharmacy Registration

Covered entities that plan to utilize contract pharmacy arrangements to dispense drugs purchased under the 340B Drug Pricing Program must register the arrangements online and
must certify electronically that fully executed agreement(s) are in effect with the contract pharmacy or pharmacies.
All agreements must satisfy the elements outlined in the guidelines that govern the operation and compliance of contract pharmacies for 340B covered entities. Prior to
registration, covered entities are strongly encouraged to have their legal counsel review all contracts and associated documents to ensure compliance with applicable Federal, State
and local requirements. OPA will not review contracts.
IMPORTANT NOTE: The contract pharmacy registration process must be started and completed within the same browser session. Incomplete online registrations
cannot be saved for later submission. Do not submit a contract pharmacy registration if you are unsure of the information you are providing, or if contract terms are still
under negotiation and/or not fully executed. It is imperative that contract pharmacy registrations are submitted accurately to avoid lengthy delays in 340B
implementation.
START DATE – The Contract Pharmacy start date is set at the time OPA approves the contract pharmacy arrangement or at a later date if requested. The contract pharmacy
arrangement should not begin prior to the start date shown on the OPA database. OPA will NOT post a retroactive start date. The contract pharmacy start date may not precede the
participating start date of the covered entity. For example, an organization added as a covered entity for the quarter beginning April 1 may not have a contract pharmacy start date
prior to that same date.
SUBMISSION PROCESS – Once you have registered a contract pharmacy online, the covered entity’s authorizing official will receive an e-mail with instructions for certifying the
arrangement. The authorizing official must perform this task within 15 calendar days from the time the online registration was completed, or the arrangement will be deleted and the
registration process must be restarted. The contract pharmacy registration process is not complete until the arrangement has been certified by the authorizing official; email
notifications will be sent to the authorizing official and the contract pharmacy representative at that time.

IMPORTANT: You must respond to the following questions before registering a contract pharmacy for the 340B program.

1. Are you authorized by the covered entity to submit this request?

2. Is the covered entity already approved for the 340B Program?

3. Do you know the 340B ID number?

4. Has the written contract between the covered entity and the pharmacy been fully executed by both parties? (Do NOT register a contract
pharmacy arrangement if the contract terms are still under negotiation.)

Yes

No

340B ID:

Covered Entity Authorizing Official Verification

340B ID

Entity
Type

Entity Name



Name:
Title:
Phone:

Ext:

Sub Name

Address

City

State

Start Date

Term Date

Edit Date

340B ID

Entity
Type

Entity Name

Sub Name

Address

City

State

Start Date

Term Date

Edit Date

Pharmacy selection– The 340B database relies on information received from the U.S. Drug Enforcement Administration (DEA); you may search for pharmacies by DEA number, name, city,
state or zip code.

DEA Number:
I do not know the Pharmacy DEA number (search by name, city, state, and/or zip).
If the pharmacy will never have a DEA certificate because the pharmacy does not dispense controlled substances, contact OPA for assistance.

340B ID

Entity
Type

Entity Name

Sub Name

Address

City

State

Start Date

Term Date

Edit Date

The number of rows returned:

Pharmacy Name

Page 1 of 1

Address

City

State

Zip

The contract begin date is set in
accordance to the registration period

Contract Begin Date:

guidelines.

340B ID:
Entity Name:
Entity Sub-Division Name:
Entity Type:
Grant Number:
StartDate:
Address:

Name:
Title:
Phone:

Name:
Address:

* Name:
(First name, Last name - ie., John Smith)
Ext:

*Title:

Medicaid Billing
* Phone:
The contract pharmacy will not dispense 340B drugs to Medicaid fee-forservice patients and subsequently bill Medicaid fee-for-service for those
transactions.

(xxx-xxx-xxxx)

*Email:

The contract pharmacy will dispense 340B drugs to Medicaid
fee-for-service patients and subsequently bill Medicaid fee-forservice for these transactions, and an established arrangement
of the covered entity, the contract pharmacy and the State
Medicaid agency has been reported by the covered entity to
HRSA/OPA.

Ext:

The contract begin date is set in
accordance to the registration period
guidelines.

Contract Begin Date:

340B ID:
Entity Name:
Entity Sub-Division Name:
Entity Type:
Grant Number:
StartDate:
Address:

Name:
Title:
Phone:

Ext:

Instructions:
To register additional contracts for this covered entity, click Add Contract.
To edit contract pharmacy representative details on an existing contract, click the appropriate representative’s information in the table below.
To remove contract(s) from the registration, click the appropriate Remove link below.

The number of rows returned: 1

Pharmacy Name

Pharmacy Address

Pharmacy Representative

Medicaid

*

March 06, 2015

1:16 PM ET

[email protected] | 1-888-340-2787

Remove Registration?

Remove

OMB Number: 0915-0327, Expiration: 09/30/2018

Ask Questions | Viewers & Players | Privacy Policy | Disclaimers | Accessibility | Freedom of Information Act | No Fear Act | USA.gov | WhiteHouse.gov | Recovery.gov

* Text will vary based on the selection on the prior screen:
Dispenses 340B drugs to Medicaid patients and subsequently bills Medicaid for those transactions
-- OR -The contract pharmacy will not dispense 340B drugs to Medicaid patients, nor subsequently bill Medicaid for those transactions.

Requestor

* Name:
* Title:
* Organization:
* Phone:
(xxx-xxx-xxxx)
* Email:
Remarks:

Ext:

340B ID: DSH999999 XYZ MEDICAL CENTER
A contract pharmacy registration has been submitted regarding DSH999999 – XYZ MEDICAL CENTER, at 1 HOSPITAL DR, ANYWHERE, AR 99999
Contract pharmacy registrations are available to be approved or rejected for 15 calendar days after submission. On the 16th d ay, any contract
pharmacy registrations that have not been approved or rejected will expire.
You may approve or reject multiple pharmacies at once, but approvals and rejections must be done separately. Click the checkb oxes next to the
pharmacies you wish to approve or reject, then review and agree to the certification statement, then click the appropriate button below. If
necessary, repeat the above steps to approve or reject the remaining registrations.

NOTE: Approving or rejecting a registration is final – your selection cannot be changed.

Request Number:

CP999999

Requestor Details

* Text will vary based on selection at registration
Dispenses 340B drugs to Medicaid patients and
subsequently bills Medicaid for those transactions
-- OR -The contract pharmacy will not dispense 340B drugs to
Medicaid patients, nor subsequently bill Medicaid for those
transactions.

Name: John Smith
Title: Pharmacy Director
Organization: XYZ Medical Center
Phone: 999-999-9999 Ext:
Email: [email protected]
Remarks:

Select
All

Pharmacy Name

TEST PHARMACY

Pharmacy Address

1 MAIN STREET
ANYWHERE, AR

CP Representative

Medicaid

Test Representative
Test
999-999-9999
[email protected]

[see note above]

Request Status

Submitted

By checking this box, I represent and confirm that I am fully authorized to bind the Covered Entity and the Pharmacy listed, and certify that the contents of any
statement made or reflected in this document are truthful and accurate. The Covered Entity and the Pharmacy will comply with all of the requirements and
restrictions of Section 340B of the Public Health Service Act and any accompanying regulations or guidelines, including, but not limited to, the prohibitions on
duplicate discounts/rebates, and drug diversion. The Covered Entity and the Pharmacy agree to be in compliance with the provisions of the Contract Pharmacy
Services Guidelines as set forth in the Federal Register, at 75 Fed. Reg. 10272 (March 5, 2010), which can be found at http://www.gpo.gov/fdsys/pkg/FR2010-03-05/pdf/2010-4755.pdf (http://www.gpo.gov/fdsys/pkg/FR-2010-03-05/pdf/2010-4755.pdf). The authorizing official certifies on
behalf of the covered entity that the contract pharmacy arrangement will be performed in accordance with OPA requirements and guidelines including, but not
limited to, that the Covered Entity obtains sufficient information from the contractor to ensure compliance with applicable policy and legal requirements, and the
Covered entity has utilized an appropriate methodology to ensure compliance (e.g., through an independent audit or other mechanism). The Covered Entity has,
and continues to bear, full responsibility and accountability for compliance with all 340B requirements, including but not limited to any 340B violations by the
Contract Pharmacy. The Covered Entity agrees to notify the Office of Pharmacy Affairs, in writing, of any material changes in the contract arrangement and/or
material breach by the covered entity of any of the foregoing.
For any contract pharmacy arrangements where ‘Dispenses 340B drugs to Medicaid fee-for-service patients and subsequently bills Medicaid fee-forservice for those transactions' is indicated above, the Entity further attests that the contract pharmacy dispenses 340B drugs to Medicaid fee-for-service
patients through an established arrangement of the covered entity, the contract pharmacy and the State Medicaid agency that has been reported by the
covered entity to HRSA/OPA. All covered entities should notify HRSA prior to any change in Medicaid billing status. For more information, please visit the
HRSA website at http://www.hrsa.gov/opa.

Click the

Approve button to approve this contract pharmacy registration.

Click the

Reject button button to reject this contract pharmacy registration.

For additional assistance regarding 340B contract pharmacy, please contact the 340B Prime Vendor Program at 1-888-340-2787 or by email at
[email protected]. Please reference your 340B ID number in the communication.
You may also contact OPA at:
Office of Pharmacy Affairs
Mail Stop 8W05A
5600 Fishers Lane
Rockville, MD 20857
Email: [email protected]

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number for this project is 0915-0327. Public reporting burden for this collection of
information is estimated to average 1 hours per response, including the time for reviewing instructions, searching existing data sources, and completing
and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N-39, Rockville, Maryland, 20857.