Date:     February 3, 1995
     
From:     Director, Center for Biologics Evaluation and Research

Subject:  Timeframe for Licensing Irradiated Blood Products

To:       All  Registered Blood Establishments


     
Introduction

On July 22, 1993, the Center for Biologics Evaluation and
Research (CBER), FDA, issued a memorandum entitled,
"Recommendations Regarding License Amendments and Procedures for
Gamma Irradiation of Blood Products". The memorandum advised
blood establishments that licensure is required for these types
of products. This notice is being issued to emphasize the
licensing requirement and to advise blood establishments that FDA
intends to pursue its legal remedies for unlicensed blood
products shipped in interstate commerce after the timeframe
stated in this memorandum. In the interim, FDA will continue to
inspect blood establishments and review, among other things,
standard operating procedures, including those for irradiating
blood products. The primary focus of these inspections will be to
assess compliance with good manufacturing practice. 

Irradiated blood products shipped in interstate commerce for
sale, barter, or exchange are biological products subject to
license under section 351 of the Public Health Service Act. In
the July 22, 1993 memorandum, CBER provided information on
preparing blood products irradiated with gamma radiation. The
memorandum did not, however, specify a timeframe for submission
of product license supplements.


Timeframe for Licensure

This is to advise that after  September 30, 1995, FDA expects
blood establishments that intend to ship irradiated blood
products in interstate commerce to have obtained approved product
license supplements. Prospective licensees should submit product
license supplements to CBER containing the information requested
in the July 22, 1993 memorandum no later than April 1, 1995. 


Questions concerning the information required for licensure of
these products or other needed assistance in preparing and filing
applications can be sent to the Division of Blood Applications,
Office of Blood Research and Review, Center for Biologics
Evaluation and Research, Food and Drug Administration (HFM-370),
1401 Rockville Pike, Rockville, MD 20852, FAX: (301)-594-6431 or
(301) 594-1973. 


                                                     
                                      ____________________________
                                       Kathryn C. Zoon, Ph.D.