Form 340B -7 340B -7 Contract Pharmacy Self-Certification Form

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

OMB No. 0915-XXXX; Expiration Date: XX/XX/XXXX

INSTRUCTIONS FOR COMPLETING “CONTRACTED PHARMACY SERVICES SELF-CERTIFICATION FORM FOR THE 340B PROGRAM”

The “Contract Pharmacy Services Self-Certification Form for the 340B Program” must be completed by a covered entity that will utilize a contract pharmacy arrangement to dispense drugs purchased under the 340B Program, in advance of that arrangement taking effect. In order to ensure that drug manufacturers and drug wholesalers recognize contract pharmacy arrangements, covered entities that elect to utilize a contract pharmacy are required to submit to the Office of Pharmacy Affairs (OPA) a self-certification that they have signed an agreement with the contract pharmacy.

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. The OPA will not review your contract. The OPA has developed contract pharmacy services guidelines. These guidelines are designed to facilitate program implementation in covered entities that wish to utilize contract pharmacy services to dispense 340B outpatient drugs but do not have access to an "in-house" pharmacy. The agreement between the covered entity and the pharmacy should include those elements outlined in the sample Contract and the Self-Certification Form.

To ensure the legibility of the information submitted on the Self-Certification Form, it has been designed using Adobe Acrobat (for a free download link here). This software allows you to fill in the information on your personal computer. After completing the form, you will then need to print it out, sign it, and then submit it.

The Self-Certification process is not complete unless the form has been completed in its entirety (all requested information is filled in on the form) and the original, signed copy is received by OPA. You will be notified via e-mail when the arrangement has been added to the 340B web-based database. Older versions of this form may not be accepted.

NOTE ON EFFECTIVE DATE – the OPA will NOT post a back-dated effective date. To expedite the process, you may FAX the form to OPA at 301-594-4982, after the document is signed by both the covered entity and the pharmacy, but an original MUST be submitted. Every effort will be made to post the arrangement within one business day. Do not begin the Contract Pharmacy arrangement prior to its posting and effective date shown on the OPA web-based database (link). Please be aware that if your organization is being added as a covered entity in the next quarterly update, the effective date of your Self-Certification may not precede the effective date of your participation as a 340B covered entity. For example, an organization added as a covered entity for the January 1, 2007 quarter may not have a Contract Pharmacy effective date prior to January 1, 2007.

NOTE ON SIGNATURES – the Self-Certification must be signed by a responsible representative of each organization. For the covered entity, the responsible representative may be the President, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, or Program Director. For the pharmacy, the responsible representative may be the owner, the President, Chief Executive Officer, Chief Operating Officer, or Chief Financial Officer. If you are in doubt regarding the acceptability of a signature, please contact OPA prior to submitting the form.

NOTE ON CONTACT INFORMATION – please list the appropriate individuals in each organization who should be contacted if there is a question from wholesalers or manufacturers regarding the contract pharmacy arrangement.

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-XXXX. Public burden is estimated to average XX minutes per respondent, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, 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 14-33, Rockville, Maryland 20857.

Contracted Pharmacy Services Self-Certification Form for the 340B Program

This is to certify that effective __________________ a Contracted 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 represent and confirm 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 Contracted Pharmacy Services Guidelines as set forth in the Federal Register, Vol. 61, No. 165,

August 23, 1996, which may be found at link. The Covered Entity and Pharmacy agree to notify the Office of Pharmacy Affairs, in writing, if this arrangement is terminated, or if any information on this form changes.

____________________________________________________ _____________________

Signature of Responsible Representative of Covered Entity Date

_________________________________________________________________________

(Type or Print Name and Title)

____________________________________________________ _____________________

Signature of Responsible Representative of Pharmacy Date

_________________________________________________________________________

(Type or Print Name and Title)

Contact Information for: Contact Information for:

Covered Entity Pharmacy

_______________________________________ __________________________________

Name Name

_______________________________________ __________________________________

Title Title

_______________________________________ __________________________________

Telephone Number Telephone Number

_______________________________________ __________________________________

FAX Number FAX Number

_______________________________________ __________________________________

E-mail address E-mail address

Addendum

340B ID Number: ____________________________________________________________

Covered Entity Name: ____________________________________________________________ Street Address: ____________________________________________________________

____________________________________________________________

City, State, ZIP: ____________________________________________________________

In addition to the Covered Entity listed in the self-certification form, the following entities are sites that will need to add the same contract pharmacy arrangement information to the pharmacy listed in the self-certification form.

#	340B ID	Sub-Division Name	Address	City	State	Zip Code
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

You may FAX a copy to 301-594-4982, however, you must also submit a signed, original form to:

Office of Pharmacy Affairs, 5600 Fishers Lane, Mail Stop 10C-03, Rockville, MD 20857

For assistance, call 1-800-628-6297