[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1270.43]

[Page 714]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1270_HUMAN TISSUE INTENDED FOR TRANSPLANTATION--Table of Contents
 
              Subpart D_Inspection of Tissue Establishments
 
Sec. 1270.43  Retention, recall, and destruction of human tissue.

    (a) Upon a finding that human tissue may be in violation of the 
regulations in this part, an authorized Food and Drug Administration 
(FDA) representative may:
    (1) Serve upon the person who distributed the tissue a written order 
that the tissue be recalled and/or destroyed, as appropriate, and upon 
persons in possession of the tissue that the tissue shall be retained 
until it is recalled by the distributor, destroyed, or disposed of as 
agreed by FDA, or the safety of the tissue is confirmed; and/or
    (2) Take possession of and/or destroy the violative tissue.
    (b) The written order will ordinarily provide that the human tissue 
be recalled and/or destroyed within 5 working days from the date of 
receipt of the order and will state with particularity the facts that 
justify the order.
    (c) After receipt of an order under this part, the person in 
possession of the human tissue shall not distribute or dispose of the 
tissue in any manner except to recall and/or destroy the tissue 
consistent with the provisions of the order, under the supervision of an 
authorized official of FDA.
    (d) In lieu of paragraphs (b) and (c) of this section, other 
arrangements for assuring the proper disposition of the tissue may be 
agreed upon by the person receiving the written order and an authorized 
official of FDA. Such arrangements may include providing FDA with 
records or other written information that adequately assure that the 
tissue has been recovered, screened, tested, processed, stored, and 
distributed in conformance with part 1270.
    (e) Within 5 working days of receipt of a written order for 
retention, recall, and/or destruction of tissue (or within 5 working 
days of the agency's possession of such tissue), the recipient of the 
written order or prior possessor of such tissue shall request a hearing 
on the matter in accordance with part 16 of this chapter. The order for 
destruction will be held in abeyance pending resolution of the hearing 
request.

[[Page 715]]