Document 0008
 DOCN  M9440008
 TI    Human tissue intended for transplantation--FDA. Interim rule;
       opportunity for public comment.
 DT    9404
 SO    Fed Regist. 1993 Dec 14;58(238):65514-21. Unique Identifier : AIDSLINE
       AHA/94130140
 AB    The Food and Drug Administration (FDA) is issuing an interim rule to
       require certain infectious disease testing, donor screening, and
       recordkeeping to help prevent the transmission of AIDS and hepatitis
       through human tissue used in transplantation. The regulations are
       effective upon publication. FDA is taking this action in response to
       growing concerns that some human tissue products are being offered for
       transplantation use without even the minimum donor testing and screening
       needed to protect recipients against human immunodeficiency virus (HIV)
       infection and hepatitis infection. The new regulations require all
       facilities engaged in procurement, processing, storage, or distribution
       of human tissues intended for transplant to ensure that minimum required
       infectious disease testing has been performed and that records
       documenting such testing for each tissue are available for inspection by
       FDA. The regulations also provide authority for the agency to conduct
       inspections of such facilities and to detain, recall, or destroy tissue
       for which appropriate documentation is not available.
 DE    Blood-Borne Pathogens  Communicable Disease Control/*LEGISLATION &
       JURISPRUD  Documentation/STANDARDS  Hepatitis/PREVENTION & CONTROL
       Human  HIV Infections/PREVENTION & CONTROL  Organ
       Procurement/LEGISLATION & JURISPRUD  Tissue Banks/*LEGISLATION &
       JURISPRUD/ORGANIZATION & ADMIN  United States  United States Food and
       Drug Administration  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).