[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 739]
 
                        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 D_Current Good Tissue Practice
 
Sec.  1271.210  Supplies and reagents.

    (a) Verification. You must not use supplies and reagents until they 
have been verified to meet specifications designed to prevent 
circumstances that increase the risk of the introduction, transmission, 
or spread of communicable diseases. Verification may be accomplished by 
the establishment that uses the supply or reagent, or by the vendor of 
the supply or reagent.
    (b) Reagents. Reagents used in processing and preservation of HCT/Ps 
must be sterile, where appropriate.
    (c) In-house reagents. You must validate and/or verify the processes 
used for production of in-house reagents.
    (d) Records. You must maintain the following records pertaining to 
supplies and reagents:
    (1) Records of the receipt of each supply or reagent, including the 
type, quantity, manufacturer, lot number, date of receipt, and 
expiration date;
    (2) Records of the verification of each supply or reagent, including 
test results or, in the case of vendor verification, a certificate of 
analysis from the vendor; and
    (3) Records of the lot of supply or reagent used in the manufacture 
of each HCT/P.