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MOU 225-83-3000

Memorandum of Understanding

Between
The United States Pharmacopeial Convention, Inc. 

and

The Food and Drug Administration

 

SUBJECT: Agreement with United States Pharmacopeial Convention, Inc. Regarding Review of Revisions to Compendial Requirements for Drugs (FDA-225-83-3000)

 

I. PURPOSE

This agreement defines the working arrangements between the United States Pharmacopeial Convention, Inc. (USPC), and the Food and Drug Administration (FDA) in regard to the review of revisions to compendial requirements for drugs.

 

II. BACKGROUND

USPC is the publisher of the United States Pharmacopeia and the National Formulary.  These texts and their supplements are designated by 21 U.S.C. 321 as official compendia.  Official compendial requirements are recognized in various adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act, such as 21 U.S.C. 351(b).  FDA proposed a regulation (21 CFR 314.70) in the FEDERAL REGISTER of October 19, 1982 (45 FR 46622) that would allow applicants of approved drug applications to submit changes in the conditions of their annual report to FDA if such changes were implemented to comply with an official compendial requirement.

 

It is a goal of both parties to ensure the availability on the market of uniform and high quality drugs and drug products.

 

III. SUBSTANCE OF AGREEMENT

A. An FDA-USPC Technical Committee on Human Drug Quality (the Committee) will be formed. The Committee will be composed of four members of the staff of USPC and four members of the staff of FDA as designated by each party to this agreement.

 

B. The Committee will be concerned with the review of standards, specifications, and methods of analysis for human drugs. Articles classified as biologicals, medical devices, or antibiotics are not ordinarily within the purview of the Committee.

 

C. The Committee may review and discuss matters or topics of general or specific interest related to human drug quality. By majority of the members voting, the Committee may make recommendations concerning technical matters to USPC. These recommendations may be either general or specific in nature. Members of the committee act as individual scientists and do not have authority to act on behalf of FDA or USPC.

 

D. Committee members may recommend that the Committee review any revision proposals that have been published in the Pharmacopeial Forum, that are consistent with Section III (B) of this agreement.

 

E. If information of a trade secret or of a confidential nature is provided to FDA members of the Committee by USPC Members, FDA will treat the information in accordance with its freedom of information procedures. FDA members of the Committee may divulge to USPC members only information which is otherwise available to the public under the Freedom of Information Act and FDA regulations.

 

F. After discussion and review of the data (i.e., data provided by USPC and material made available from FDA) involving a matter before the Committee under paragraph D, the following procedures shall be followed.

1. Should the revision proposal be deemed adequate, no further action will be indicated.

2. Should the revision proposal be deemed inadequate by the Committee, it may recommend that USPC request its Revision Committee to obtain additional information to support the proposal prior to its adoption. Such request shall specify, insofar as practical, the type and nature of the data to be obtained.

 

G. Minutes of meetings held by the Committee will be maintained with copies being provided to liaison officers in FDA and USPC. Copies of these minutes will be publicly available.

 

H. If policy issues develop in the course of the business of the Committee that are beyond the scope of this Working Agreement, the Committee will promptly refer these issues to the appropriate officials in FDA or USPC of resolution.

 

IV. PARTICIPATING PARTIES

A. United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway
Rockville, MD 20852

Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

 

V. LIAISON OFFICERS

A. For the United States Pharmacopeial Convention, Inc.:

Executive Associate
(Currently Joseph G. Valentino)
12601 Twinbrook Parkway
Rockville, MD 20852
Telephone: (301) 881-0666

 

B. For the Food and Drug Administration

Chief, Compendial Operations Branch (HFN-335)
(Currently I. David Wolfson)
National Center for Drugs and Biologics
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-6390

 

VI. PEROID OF AGREEMENT

This agreement becomes effective upon acceptance by both parties and shall continue indefinitely. It may be modified by mutual consent or terminated by either party upon the giving of a 60-day written notice.

Approved and Accepted
for the United States Pharmacopeial Convention, Inc.

Signed by: Executive Director and Secretary

Date: November 1, 1983

 

Approved and Accepted
for the Food and Drug Administration

Signed by: Joseph P. Hile
Associate Commissioner for Regulatory Affairs

Date: September 7, 1983