[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.440]

[Page 742-743]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS--Table of Contents
 
 Subpart F_Inspection and Enforcement of Establishments Described in   
                                 1271.10
 
Sec. 1271.440  Orders of retention, recall, destruction, and cessation of manufacturing.

    (a) Upon an agency finding that there are reasonable grounds to 
believe that an HCT/P is a violative HCT/P because it was manufactured 
in violation of the regulations in this part and, therefore, the 
conditions of manufacture of the HCT/P do not provide adequate 
protections against risks of communicable disease transmission; or the 
HCT/P is infected or contaminated so as to be a source of dangerous 
infection to humans; or an establishment is in violation of the 
regulations in this part and,

[[Page 743]]

therefore, does not provide adequate protections against the risks of 
communicable disease transmission, the Food and Drug Administration 
(FDA) may take one or more of the following actions:
    (1) Serve upon the person who distributed the HCT/P a written order 
that the HCT/P be recalled and/or destroyed, as appropriate, and upon 
persons in possession of the HCT/P that the HCT/P must be retained until 
it is recalled by the distributor, destroyed, or disposed of as agreed 
by FDA, or the safety of the HCT/P is confirmed;
    (2) Take possession of and/or destroy the violative HCT/P; or
    (3) Serve upon the establishment an order to cease manufacturing 
until compliance with the regulations of this part has been achieved. 
When FDA determines there are reasonable grounds to believe there is a 
danger to health, such order will be effective immediately. In other 
situations, such order will be effective after one of the following 
events, whichever is later:
    (i) Passage of 5 working days from the establishment's receipt of 
the order; or
    (ii) If the establishment requests a hearing in accordance with 
paragraph (e) of this section and part 16 of this chapter, a decision 
in, and in accordance with, those proceedings.
    (b) A written order issued under paragraph (a) of this section will 
state with particularity the facts that justify the order.
    (c)(1) A written order issued under paragraph (a)(1) of this section 
will ordinarily provide that the HCT/P be recalled and/or destroyed 
within 5 working days from the date of receipt of the order. After 
receipt of an order issued under paragraph (a)(1) of this section, the 
establishment in possession of the HCT/P must not distribute or dispose 
of the HCT/P in any manner except to recall and/or destroy the HCT/P 
consistent with the provisions of the order, under the supervision of 
FDA.
    (2) In lieu of paragraph (c)(1) of this section, other arrangements 
for assuring the proper disposition of the HCT/P may be agreed upon by 
the person receiving the written order and FDA. Such arrangements may 
include, among others, providing FDA with records or other written 
information that adequately ensure that the HCT/P has been recovered, 
processed, stored, and distributed in conformance with this part, and 
that, except as provided under Sec. Sec. 1271.60, 1271.65, and 1271.90, 
the donor of the cells or tissue for the HCT/P has been determined to be 
eligible.
    (d) A written order issued under paragraph (a)(3) of this section 
will specify the regulations with which you must achieve compliance and 
will ordinarily specify the particular operations covered by the order. 
After receipt of an order that is in effect and issued under paragraph 
(a)(3) of this section, you must not resume operations without prior 
written authorization of FDA.
    (e) The recipient of an order issued under this section may request 
a hearing in accordance with part 16 of this chapter. To request a 
hearing, the recipient of the written order or prior possessor of such 
HCT/P must make the request within 5 working days of receipt of a 
written order for retention, recall, destruction, and/or cessation (or 
within 5 working days of the agency's possession of an HCT/P under 
paragraph (a)(2) of this section), in accordance with part 16 of this 
chapter. An order of destruction will be held in abeyance pending 
resolution of the hearing request. Upon request under part 16 of this 
chapter, FDA will provide an opportunity for an expedited hearing for an 
order of cessation that is not stayed by the Commissioner of Food and 
Drugs.
    (f) FDA will not issue an order for the destruction of reproductive 
tissue under paragraph (a)(1) of this section, nor will it carry out 
such destruction itself under paragraph (a)(2) of this section.

                       PARTS 1272	1299 [RESERVED]