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
Instructions
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. Covered entities are not required
to provide copies of contracts at the time of registration, however Office of Pharmacy Affairs (OPA) may request and
review contracts during audits and integrity analysis checks.
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 or not fully
executed. It is imperative that contract pharmacy registrations are submitted accurately to avoid delays in 340B
implementation.
START DATE – The contract pharmacy start date is set to begin on the first day of the next quarter. 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.
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 09150327. Public reporting burden for this collection of information is estimated to average 1 hour 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 14N136B, Rockville, Maryland,
20857.
Covered Entity Details
340B ID
Entity Name
Entity Type
Notice of Funding Opportunity (NOFO) Number
Entity Sub-Division Name
Employer Identification Number (EIN)
Grant Number

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

Nature Of Support
• Direct Funding (dollars received from CDC or an intermediate organization)
• In-Kind products or services (see note below; must have been purchased with section 318 funds)
• None
Note: In-kind contributions may be in the form of real property, equipment, supplies and other expendable property, and
goods and services directly benefiting and specifically identifiable to the project or program.
Please Describe the “in-kind” Support
Time period section 318 funding or in-kind support was received
Contract Pharmacies for [340B ID]
Pharmacy Name
Address
Address Cont.
City
State
Zip Code
Approval Date
340B Status
Search Pharmacy

Pharmacy selection – 340B OPAIS 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.
Search Results
Select
Pharmacy Name

Address

Address Cont.

City

State

Zip Code

Contract Details
Contract Begin Date:
The contract begin date is set in accordance to the registration period guidelines.
Pharmacy Representative
Please enter an Email Address and then click on search.
Email Address_____________________________________________________________________
Name____________________________________________________________________________
Title______________________________________________________________________________
Organization_______________________________________________________________________
Phone____________________________________________________________________________
Authorizing Official Signature
The undersigned represents and confirms that he/she is fully authorized to legally 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.
As an Authorized Official, I certify on behalf of the covered entity that:
1. 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 (section 340B(a)(5)(A) and (B) of the Public Health Service Act).

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

2. 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/FR-2010-03-05/pdf/2010-4755.pdf.
3. 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).
4. 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.
5. The Covered Entity agrees to notify the Office of Pharmacy Affairs, in writing, of any changes in the contract
arrangement and/or breach by the covered entity of any of the foregoing.

By checking this box, I confirm that I have read the above statements and fully understand my obligations.