Form 1 Contract Pharmacy Registrationform Revised

Dept. of Health and Human Services, Health Resources and Services Administration, HealthCare Systems Bureau

INSTRUCTIONS FOR COMPLETING THE “ONLINE CONTRACT PHARMACY REGISTRATION FORM”
FOR THE 340B DRUG PRICING PROGRAM
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 submit the Online Contract Pharmacy Registration Form that
is generated at the end of the online process to the Office of Pharmacy Affairs (OPA) for each contract. This registration
form must be completed and submitted according to the established deadlines that are published on the OPA
website (www.hrsa.gov/opa).
OPA only accepts online contract pharmacy registrations at http://opanet.hrsa.gov/opal/default.aspx.
IMPORTANT NOTE: The Registration Process must be started and completed within the same browser session.
Incomplete Registration Forms cannot be saved for later submission. It is imperative that pharmacy names and
addresses are added accurately during the registration process to avoid lengthy delays in 340B implementation.
Prior to registering a contract pharmacy online, a covered entity must have their own legal counsel review all contracts or
other legal documents to ensure that all Federal, State and local requirements have been met. OPA will not review contracts.
The agreement between the covered entity and the contract pharmacy must be fully executed and include those elements
outlined in the Contract Pharmacy Services Guidelines (http://edocket.access.gpo.gov/2010/pdf/2010-4755.pdf).
START DATE – 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 (http://opanet.hrsa.gov/opa/CP/CPExtract.aspx). The contract pharmacy
start date may not precede the registration date of the covered entity. For example, an organization added as a covered entity
for the April 1, 2012 quarter may not have a contract pharmacy start date prior to April 1, 2012.

Online Contract Pharmacy Registration Form - This form must be completed and signed by both parties involved in a
contract pharmacy arrangement. The Registration Form must be signed for each contract and must be submitted with the
addenda or relevant addendum. By submitting this registration form to OPA, the covered entity and contract pharmacy certify
that a written contract is in effect between both parties. It is NOT acceptable to register a contract pharmacy if contract terms
are still under negotiations and/or not fully executed.
SIGNATURES – The Registration Form must be signed by the covered entity’s Authorizing Official. For the pharmacy, the
responsible representative may be the owner, the president, chief executive officer, etc. If you are in doubt regarding the
acceptability of a signature, please contact OPA prior to submitting the form. Please note that OPA does not have the
capability of receiving electronic signatures at this time and will begin processing the online submissions of the
Contract Pharmacy Registration Form only after receiving a copy or the original with the required signatures.
SUBMISSION PROCESS – Once you have registered a contract pharmacy online, the responsible parties must sign the
Online Contract Pharmacy Registration form that is generated at the end of online process. OPA offers multiple options for
submitting the Registration Form:
1. Email: Scan the form and email it to [email protected] .
2. Fax: Covered entities may fax the forms to OPA at 301-594-4982 before mailing the originals.
3. Mail: Covered entities must mail originals to Office of Pharmacy Affairs, 5600 Fishers Lane, Room 10C-03, Rockville,
MD 20857.
4. Data Upload: To register more than 20 covered entity- contract pharmacy arrangements, covered entities may
request a data upload by e-mailing [email protected] .
Submit the signed Contract Pharmacy Registration forms to OPA within 15 days from the time the online registration was
completed. If the fully signed registration form is not received within this time period, the contract pharmacy registration will be
deleted from the system and the registration process must be started over again. The Contract Pharmacy Registration
process is not complete unless the form has been completed in its entirety and the original, signed copy is received
by OPA. Email notifications will be sent once the registration has been processed.

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IMPORTANT: Prior to registering a Contract Pharmacy fir the 340B Program, there should be a Covered Entity registered and approved by OPA. If the
Covered Entity is not approved in the 340B system, you are unable to complete the Registration form and will be returned to the HRSA Homepage.

4. Have the legal documents been reviewed and the written contract fully executed? Note: Prior to completing this form, a
Covered Entity must have their own legal counsel review all contracts or other legal documents to ensure that all Federal,
State, and local requirements have been met.

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Please review the list of active Contract Pharmacies. If you want to request a Contract Pharmacy termination, select the appropriate contract(s) and
requested termination date(s). If all Contract Pharmacies are valid, select the appropriate option to continue adding the contract.
Note: Submitting a request to terminate contracts sends an email notification to the Office of Pharmacy Affairs to review the request. It does not
automatically terminate the Contract Pharmacy in the 340B application.
Request Contract Pharmacy termination(s) then continue adding a Contract Pharmacy Arrangement.
I do not want to submit any request for Contract Pharmacy termination(s) at this time. Continue adding Contract Pharmacy Arrangement.

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This date must be equal to or greater than the Covered Entity Start Date and cannot be
less than the current date. NOTE: Allow 10 to 15 business days for approval. Approval
time may be longer dependant on workload and registration discrepancies. The
Contract Pharmacy arrangement is not valid until it has been approved by OPA.

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[email protected]

Dept. of Health and Human Services, Health Resources and Services Administration, HealthCare Systems Bureau

Online Contract Pharmacy Registration Form for the 340B Program
This is to certify that effective _________ a Contract Pharmacy Services arrangement is in effect between:
340B ID Number:
Covered Entity Name:
Street Address:
City, State, Zip:
and
Pharmacy Name:
Street Address:
City, State, Zip:

The undersigned represents and confirms that he/she is fully authorized to bind the Covered Entity or the Pharmacy listed, and certifies 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/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.

____________________________________________
Signature of Authorizing Official of Covered Entity

____________
Date

__________________________
(Type or Print Name and Title)
___________________________________________
Signature of Responsible Representative of Pharmacy
__________________________
(Type or Print Name and Title)

____________
Date