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MOU 224-76-8049

Memorandum of Understanding

Between
The Veterans Administration

and

The Food and Drug Administration

I. Purpose

To formalize an agreement between the Veterans Administration (VA) and the Food and Drug Administration (FDA) by which FDA is to be responsible for providing quality assurance for all drugs, biologics, chemicals, and reagents VA procures, stores, and distributes, including its Federal Supply Schedule assignment.

II. Background

The Office of Management and Budget (OMB) and the General Accounting Office (GAO) completed separate studies in late 1973 and early 1974 of the Federal procurement of medical and non-perishable subsistence supplies. The OMB and GAO recommended that the Food and Drug Administration be the agency responsible for quality assurance of all medical products procured by Federal agencies. In June 1974, the Director of OMB requested that the Department of HEW take the lead in developing an Executive Branch plan for Government-Wide Quality Assurance Program. FDA is responsible for developing and implementing the plan. FDA decided that due to the great diversity of medical products procured by the Federal Government, it would be desirable to first develop a quality assurance program covering drugs and biologics, and to include all other medial products in a second phase of the program. This agreement is the mechanism for FDA's assuming the responsibility for quality assurance for drugs and biologics VA procures, stores, and distributes.

III. The Veterans Administration and the Food and Drug Administration Agree:

A. FDA will be responsible for quality assurance for all drugs, biologics, chemicals, and reagents VA purchases, stores, and distributes, including its Federal Supply Schedule assignment;

B. The Current Good Manufacturing Practice Regulations (CGMPRS's) (21 CFR Part 133) will be the single standard to be applied industry-wide for the manufacture, processing, packing or holding of drugs procured by governmental agencies;
C. The Food and Drug Administration will be the agency responsible for administrative interpretation and enforcement of the CGMPR's;

D. Existing procedural and policy guides and standards employed by VA will remain applicable until such time as FDA assumes formal responsibility for the quality assurance functions to which the guides and standards apply;

E. FDA will be responsible for and will conduct all inspectional work associated with the quality assurance of drugs, biologics, chemicals, and reagents. This responsibility will be assumed beginning July 1, 1975;

F. FDA will assume full responsibility for performing all laboratory testing relating to the quality assurance of drugs, biologics, chemicals, and reagents on July 1, 1975;

G. FDA will not certify the quality capability of a firm for procurement if the firm is not in business, or if the nature of the firm's operations does not allow a proper evaluation to be made of the firm's ability to produce a product of acceptable quality;

H. The purchasing agency shall continue to prepare and to be responsible for purchasing specifications. FDA will be responsible for review and concurrence in the parts of purchasing specifications that concern drug and biologic quality. Whatever public and private drug biologic product quality specifications are applicable to the general public will also apply to government procurements. For those products for which there are official published specifications of quality, or for which there are approved New Drug Applications (NDA's) or Abbreviated New Drug Applications (ANDA's), approved antibiotic Form 6's, or FDA licensing, the quality assurance requirements therein will be the quality assurance requirements for procurement purposes, and a reference to such a requirement in the procurement specifications shall be sufficient to define the quality requirement. A special purchase specification that impinges on quality specifications may be justified by VA, when it is required because of VA special needs.

IV. The Veterans Administration Agrees:
A. To furnish to FDA all relevant information needed by FDA concerning the firm and the products involved, when requesting a quality assurance evaluation of the firm's capability to supply a quality drug, biologic, chemical, or reagent;

B. To inform FDA immediately whenever any information is received which may impact adversely on the quality assurance of any firm or product;

C. To furnish justification when requesting that FDA conduct an on-site inspection of a firm, analysis of a product, or other work VA believes necessary;

D. To participate fully in FDA's drug defect reporting system, in addition to conducting its own internal reporting system;

E. To submit samples and request analysis in accordance with procedures FDA establishes.

V. The Food and Drug Administration Agrees:

A. To continue in a timely manner to revise and update the CGMPR's and to promulgate new CGMPR's for specific segments of the industry;

B. To review procedural and policy guidance relating to standards currently in use by VA and incorporate as appropriate into FDA guidance systems;

C. To publish in FDA's Inspection Operations Manual, or other appropriate publication, a listing of commonly used terms relating to the CGMPR's and the standards VA has been using, with definitions of the terms that will be recognized by all involved parties;

D. To furnish to VA, on request, an annual quality assurance evaluation of a firm's capability to supply products which meet quality standard and are in compliance with laws FDA enforces. For those firms from whom VA is considering acquiring drugs, biologics, chemicals, or reagents for the first time, FDA will on request furnish a quality evaluation within 10 workdays after receipt of the request. The evaluation of an establishment will be based on information in FDA files which reflects the current operations and status of the firm. There will be instances when an inspection will be required to obtain additional information, in order for FDA to properly evaluate an establishment. FDA will conduct such inspections when they are deemed necessary. The following are FDA's internal guidelines for determining the need for an on-site inspection:

1. Inspection indicated:

a. There has been no inspection of the establishment within the past 24 months which adequately covered the category of product(s) involved; or

b. Affirmative information is available which puts in reasonable doubt the ability of the establishment to produce a quality product; or,

c. The purchasing agency requests, and FDA concurs, that a special circumstance requires an inspection be made. (FDA will honor specific requests from VA that an on-site inspection be conducted to the maximum extent possible.)

2. Inspection not indicated:

There has been an inspection of the establishment within the past 24 months which covered the category of product and found the quality assurance satisfactory; and there is no affirmative information available to put in doubt or negate the findings of the last inspection;


E. To make the determination of when analysis of sample is required for evaluation of quality;

F. To perform analytical work in support of VA's customer complaint program, and in the extension of expiration dates/shelf life as required;

G. To complete analytical work and report the results to VA within 14 workdays following receipt of the sample by the proper laboratory facility. There will be instances where the 14-day deadline cannot be met due to the nature of the analysis required. In all instances, sample analysis for VA will be handled in the most expeditious manner possible;

H. To undertake an orderly process to review VA's drug and biologic product quality purchase specifications, and retain only those which are applicable to product quality. In the review process, first priority will be given to drugs of highest medical significance;

I. To accommodate the varying needs of the Veterans Administration to the maximum extent feasible.

VI. Name and Address of Participating Activities

Veterans Administration
810 Vermont Ave.
Washington, DC, 20420

Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland, 20857

VII. Liaison Officers

For the Veterans Administration:

Robert G. Rose
Director, VA Marketing Center
P.O. Box 76
Hines, Illinois 60141
(312) 261-2801

For the Food and Drug Administration:

Director
Medical Products Quality Assurance Staff (HFC-50)
Office of the Associate Commissioner for Compliance
5600 Fishers Lane
Rockville, Maryland 20857
(301) 443-1645.

VIII. Period of Agreement

This agreement, when accepted by both parties, will have an effective period from July 1, 1975, or date of signature, whichever is later, with no expiration date, and may be terminated by either party, with concurrence of OMB, upon 90 day's advance written notice to the other party.

IX. Revisions

Additional procedures and revisions as may be necessary for the implementation of this agreement and to effectuate the intention of the parties may be developed jointly by FDA and VA. Such revisions shall become effective on such date as is mutually agreed upon by the parties.

X. Funding and Support

Two (2.0) positions and $208,000. to accomplish these activities will be provided by real transfers to FDA from VA in FY 1976 and through transfers in the appropriation estimates for FY 1977. Thereafter, regular provisions for these activities will be included in FDA budget requests. The initial level of support will be determined and mutually agreed to by the signatory agencies prior to the effective date of this agreement.

XI. Authority

This agreement is entered into under the authority of the Economy Act approved June 30, 1932, as amended (31 U.S.C. 686).

Approved and Accepted
for the Veterans Administration

Signed by: Director, Supply Service

Date: June 19, 1975

Approved and Accepted
for the Food and Drug Administration

Signed by: Gerald F. Meyers
Associate Commissioner for Administration

Date: June 12, 1975