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MOU 225-74-1017

Memorandum of Understanding

Between
The Department of Defense 

and

The United States Department of Health, Education and Welfare
Food and Drug Administration

 

SUBJECT: MOU with Department of Defense Regarding Licensure of Military Blood Banks (FDA 225-74-1017)

 

The Department of Defense (hereinafter called DOD) and the Food and Drug Administration of the Department of Health, Education and Welfare (hereinafter called FDA) jointly agree to the terms and conditions as described herein.

 

PURPOSE:

To establish a uniform policy between the Department of Defense and the Food and Drug Administration relative to the voluntary licensure of military blood banks pursuant to Section 351 of the Public Health Service Act.

 

BACKGROUND:

Blood, blood components or derivatives, or analogous products applicable to the prevention, treatment, or cure of diseases or injuries of man (henceforth referred to as biological products) are potentially subject to the licensing provisions of Section 351 of the Public Health Service Act, which is enforced by the Bureau of Biologics of the Food and Drug Administration. These biological products are human "drugs" as that word is defined under the Federal Food, Drug, and Cosmetic Act, which is also enforced by the FDA. Biological products and the manufacture of such products are therefore subject to both Section 351 of the Public Health Service Act and the human drug provisions of the Federal Food, Drug, and Cosmetic Act.

 

The Department of Defense wishes to voluntarily avail itself of the licensing provisions of Section 351 of the Public Health Service Act, to enable the military to more freely and expeditiously exchange blood components with civilian blood banks to more effectively utilize this vital national blood resource. The Food and Drug Administration, for its part, looks with favor upon the entrance and integration of certain aspects of the military blood system with that of the civilian system to move the nation's blood services complex more nearly towards one nationwide system with uniform standards of quality and safety.

 

Inasmuch as both the Food and Drug Administration and the Department of Defense recognize the unique nature and capabilities of the military blood banking system, and in recognition of their mutual recognition of the military need for flexibility to assure the common defense, a mechanism to implement the licensing provisions of Section 351 of the Public Health Service Act has been agreed upon which will adequately serve the public health goals of Section 351 without in any way compromising the military's capacity to respond effectively in meeting urgent military requirements.

 

I. Substance of Agreement

The Food and Drug Administration and the Department of Defense agree that:

A. Upon application for FDA license, each military department volunteers to be licensed with respect to its military blood program.

B. Each military department will apply to the Food and Drug Administration for issue of a separate license. These licenses will be equivalent to those issued to civilian blood programs in accordance with section 351 of the Public Health Service Act. Exceptions to the license not covered in this agreement will be coordinated by the military department concerned with the Food and Drug Administration.

C. Each military department will insure that its blood banking facilities will meet the standards prescribed and are operated in accordance with FDA blood banking regulations. Each military department on its own or in conjunction with other military departments, will provide for the inspection of its blood banks by qualified personnel to insure that the facilities are operated in accordance with FDA regulations. The inspections will use criteria equivalent to or exceeding those employed in the inspection of civilian blood banks.

D. FDA inspection of military blood banking facilities will be conducted as deemed necessary and will be coordinated with the licensee of each military department.

E. Discrepancies noted or deviations from the governing FDA regulations will be reported to the Surgeon General of the military service involved by the designated inspectors. Each Surgeon General shall be responsible for taking the corrective action necessary to insure compliance. Inspection reports will be available to both the Surgeons General and the FDA.

F. For national security, the Department of Defense must maintain a worldwide capability for medical care. The military departments during military operations, military and/or civilian emergencies may be required to deviate from the blood banking standards of the FDA. FDA will be made aware of the deviations from the FDA standards and their medical implications.

 

II. Name and Address of Participating Agencies

A. Department of Defense
Washington, D.C. 20314

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

 

III. Liaison Officers

A. Hall G. Etter, COL, BSC, USAF
Director of Military Blood Program Office
Office of Surgeon General
U.S. Army
Department of Defense
Washington, D.C. 20314
Telephone: 202-693-5575

B. Mr. James O. Gesling
Associate Director
Bureau of Biologics, HFB-3
Food and Drug Administration
8800 Rockville Pike
Bethesda, Maryland 20014
Telephone: 301-496-6807

 

IV. Period of Agreement

This agreement, when accepted by both agencies, covers an indefinite period of time, and may be modified by mutual consent of both parties or terminated by either party upon thirty (30) day advance written notice to the other.

Approved and Accepted
for the Department of Defense

Signed by: N. McKanzie
Act. Asst. Secretary of (Health and Environment)

Date: June 19, 1974

Approved and Accepted
for the Food and Drug Administration

Signed by: A.M. Schmidt
Commissioner of Food and Drugs

Date: May 21, 1974