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MOU 225-11-0023

MEMORANDUM OF UNDERSTANDING BETWEEN THE
NATIONAL ASSOCIATION OF BOARDS OF PHARMACY AND
THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

 

 

COOPERATION CONCERNING ILLEGAL PRESCRIBING AND DISPENSING OF PRESCRIPTION  DRUGS ON THE INTERNET

I.  Preamble:  This memorandum  of understanding (MOU) explains the procedures by which the U.S. Food and Drug Administration (FDA) and the National Association of Boards of Pharmacy (NABP) (hereinafter jointly referred to as "the Parties") will share information and work cooperatively  to enforce federal and state laws and regulations relating to illegal domestic prescribing and dispensing of prescription drugs on the Internet.

II.  Purpose:  The purpose of this MOU is to formalize cooperative efforts between FDA and NABP to enhance enforcement of applicable statutes and regulations, including the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301et seq., and its implementing  regulations, and state statutes and regulations, to protect patients from
harm resulting from illegal domestic prescribing and dispensing of prescription drugs on the Internet.

Ill.  Authority:  FDA is charged with enforcement of the FFDCA and its implementing regulations and state authorities are charged with enforcing applicable state statutes and regulations. FDA and NABP agree that nothing in this MOU relieves FDA or any NABP member board of pharmacy of its statutory and regulatory responsibilities. The Parties also recognize that this document does not restrict FDA or any NABP member board of pharmacy from taking appropriate enforcement action where necessary to ensure compliance with the FFDCA and its implementing regulations or state statutes and regulations. This document does not create or confer any rights for or on any person.

IV.  Background:  FDA and NABP have significant concerns about individuals and entities that illegally dispense FDA-approved prescription drugs and that illegally practice
 
pharmacy via the Internet without a valid prescription. These practices are a violation of the FFDCA, and involve professional practice areas regulated by the States as well. These practices are concerning because patients who buy prescription drugs from or receive prescriptions from such entities or individuals are at risk for suffering life­
threatening adverse events. The risks include side effects from inappropriately prescribed
medications, dangerous drug interactions, and contaminated or otherwise unsafe drugs.

To address these concerns, FDA and NABP agree to work cooperatively to see that enforcement actions are brought against illegal domestic dispensers and prescribers of• prescription drugs under state law, federal law, or both as appropriate.


V.  Responsibilities: FDA and NABP agree to work cooperatively to, bring effective enforcement actions against illegal domestic dispensers and prescribers of prescription drugs on the Internet. The Parties agree to share information, when appropriate and consistent with applicable law, to further the purpose and goals of this MOD.

This agreement will not preclude FDA from informing, in addition to NABP, any appropriate state medical boards, any appropriate state boards of pharmacy, and/or any appropriate state attorney general's offices of potential illegal prescribing or dispensing of prescription drugs on the Internet when information obtained by FDA potentially involves: 1) the dispensing of a prescription drug by a domestic non-licensed pharmacy and/or non-registered pharmacists; or 2) the dispensing of a prescription drug without a valid prescription.  Notification may be withheld in the event of (but not limited to) the following:  (1) an investigation is being planned or conducted by any organizational component of FDA (including, but not limited to, the Office of Criminal Investigations ("FDA-OCI'')) or the Department of Justice; (2) information is expected or received by FDA regarding an investigation being planned or conducted by another Federal/State/local  law enforcement agency; or (3) sharing of information is not authorized by applicable laws, regulations, or policies.

It is understood that:

A.  FDA will follow its regulatory procedures before sharing non-public information with
NABP.
B.  All non-public information received by NABP from FDA remains FDA's property and NABP will return, delete or destroy any and all non-public information shared by FDA with NABP pursuant to this MOD, whether electronic or otherwise, upon request by FDA.
C.  Unauthorized disclosure of confidential commercial information or trade secrets
could be a criminal violation of United States law.

Each party to this MOD reserves the right to determine whether it will or will not pursue a particular case. And nothing in this MOD should be construed to preclude FDA or any NABP member boards of pharmacy from taking appropriate enforcement action.
 

In addition to other information, NABP will make available to FDA the following:

  • Appropriate information from the NABP Clearinghouse Database to assist in the identification of licensed pharmacies and pharmacists;
  • All public disciplinary actions maintained in the Clearinghouse Database;
  • All periodic Reports to Regulators arising from the NABP Internet Drug Outlet
  • Identification Program.

VI.  Resource Obligations:  This MOU represents the broad outline of the Parties' intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and NABP. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds.  This MOU does not affect or supersede any existing or future agreements or arrangements between the Parties. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NABP operate.

VII.   Confidentiality:  NABP understands and agrees that information FDA shares pursuant to this MOU may include non-public information, pre-decisional documents, and investigatory  records.  NABP agrees that it will not further disclose information shared under this MOU without written authorization from FDA.  Further, as applicable, NABP understands and agrees that any information  shared pursuant to this MOU will be subject to the specific terms and conditions set forth in any subsequent written agreement between FDA and the recipient, or any subsequent written commitment from the recipient.


VIII.  Liaison Officers:

FDA

a.   Criminal Internet Enforcement Issues

Glenn Watson, Senior Operation Manager (or his successor or designee) Office of Criminal Investigations
U.S. FDA
7500 Standish Place, Room 250N Rockville, MD 20855
240-276-9500
Glenn.Watson@oci.fda.gov
 
b.   Civil Internet Enforcement Issues

Ilisa Bernstein, Deputy Director (or her successor or designee) Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD  20993
301-796-4723
Ilisa.Bemstein@fda.hhs.gov

NABP

Carmen Catizone, Executive Director
National Association of Boards of Pharmacy
1600 Feehanville Drive
Mount Prospect, IL
847-391-4400
exc-office@nabp.net


IX.  Assessment Mechanisms:
Interim evaluations of progress will occur annually and a final evaluation will occur on or shortly before the third anniversary of the effective date ofhis MOU. Evaluations will
assess cooperative efforts reflecting the extent to which goals to protect patients from harm resulting from illegal domestic prescribing and dispensing of prescription drugs on the Internet have been met. The evaluations will be performed jointly by FDA and NABP and may occur by teleconference or face-to-face meeting.


X.  Effective Period:  This MOU, when accepted by both Parties, will have an effective
period of performance from the date of the latest signature until three years from that date and may be modified or terminated by mutual written consent by both Parties or may be terminated by either Party for any reason upon a thirty day advance written notice to the other  Termination of this MOU or any related agreements does not relieve NABP of the confidentiality obligations established herein or in any other agreements, including its obligation to safeguard and limit disclosure of all information provided pursuant to this MOU.
 
XI.  Signatures of Responsible Parties:


 

ACCEPTED AND APPROVED FOR THE NATIONAL ASSOCIATION OF BOARDS AND PHARMACY

Signed by:Carmen A. Catizone
Executive Director/Secretary
National Association of Boards of Pharmacy   
Date:August 26, 2011
 

ACCEPTED AND APPROVED FOR THR FOOD AND DRUG ADMINISTRATION

Signed by:Kathy-Weiss 
Acting Director, Office of Criminal Investigations
U.S. Food and Drug Administration
Date:August 11, 2011
 

Signed by:Janet Wodcock
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration   
Date:August 18, 2011