[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 729-730]
 
                        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 C_Donor Eligibility
 
Sec.  1271.60  What quarantine and other requirements apply before the 
donor-eligibility determination is complete?

    (a) Quarantine. You must keep an HCT/P in quarantine, as defined in 
Sec.  1271.3(q), until completion of the donor-eligibility determination 
required by Sec.  1271.50. You must quarantine semen from anonymous 
donors until the retesting required under Sec.  1271.85(d) is complete.
    (b) Identification of HCT/Ps in quarantine. You must clearly 
identify as quarantined an HCT/P that is in quarantine pending 
completion of a donor-eligibility determination. The quarantined HCT/P 
must be easily distinguishable from HCT/Ps that are available for 
release and distribution.
    (c) Shipping of HCT/Ps in quarantine. If you ship an HCT/P before 
completion of the donor-eligibility determination, you must keep it in 
quarantine during shipment. The HCT/P must be accompanied by records:
    (1) Identifying the donor (e.g., by a distinct identification code 
affixed to the HCT/P container);
    (2) Stating that the donor-eligibility determination has not been 
completed; and
    (3) Stating that the product must not be implanted, transplanted, 
infused, or transferred until completion of the donor-eligibility 
determination, except under the terms of paragraph (d) of this section.
    (d) Use in cases of urgent medical need. (1) This subpart C does not 
prohibit the implantation, transplantation, infusion, or transfer of an 
HCT/P from a donor for whom the donor-eligibility determination is not 
complete if there

[[Page 730]]

is a documented urgent medical need for the HCT/P, as defined in Sec.  
1271.3(u).
    (2) If you make an HCT/P available for use under the provisions of 
paragraph (d)(1) of this section, you must prominently label it ``NOT 
EVALUATED FOR INFECTIOUS SUBSTANCES,'' and `` WARNING: Advise patient of 
communicable disease risks.'' The following information must accompany 
the HCT/P:
    (i) The results of any donor screening required under Sec.  1271.75 
that has been completed;
    (ii) The results of any testing required under Sec.  1271.80 or 
1271.85 that has been completed; and
    (iii) A list of any screening or testing required under Sec.  
1271.75, 1271.80 or 1271.85 that has not yet been completed.
    (3) If you are the establishment that manufactured an HCT/P used 
under the provisions of paragraph (d)(1) of this section, you must 
document that you notified the physician using the HCT/P that the 
testing and screening were not complete.
    (4) In the case of an HCT/P used for an urgent medical need under 
the provisions of paragraph (d)(1) of this section, you must complete 
the donor-eligibility determination during or after the use of the HCT/
P, and you must inform the physician of the results of the 
determination.