EVERSIGHT SERVICES
SURGEON FORMS
TITLE 21 FOOD AND DRUGS
CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER L – REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
PART 1271 – HUMAN CELLS , TISSUES , AND CELLULAR AND TISSUE-BASED PRODUCTS Subpart D – Current Good Tissue Practice Sec . 1271.290 Tracking
( a ) General . If you perform any step in the manufacture of an HCT / P in which you handle the HCT / P , you must track each such HCT / P in accordance with this section , to facilitate the investigation of actual or suspected transmission of communicable disease and take appropriate and timely corrective action .
( b ) System of HCT / P tracking . ( 1 ) You must establish and maintain a system of HCT / P tracking that enables the tracking of all HCT / Ps from :
( i ) The donor to the consignee or final disposition ; and ( ii ) The consignee or final disposition to the donor .
( 2 ) Alternatively , if you are an establishment that performs some but not all of the steps in the manufacture of an HCT / P in which you handle the HCT / P , you may participate in a system of HCT / P tracking established and maintained by another establishment responsible for other steps in the manufacture of the same HCT / P , provided that the tracking system complies with all the requirements of this section .
( c ) Distinct identification code . As part of your tracking system , you must ensure : That each HCT / P that you manufacture is assigned and labeled with a distinct identification code , e . g ., alphanumeric , that relates the HCT / P to the donor and to all records pertaining to the HCT / P ; and that labeling includes information designed to facilitate effective tracking , using the distinct identification code , from the donor to the recipient and from the recipient to the donor . Except as described in 1271.55 ( a )( 1 ), you must create such a code specifically for tracking , and it may not include an individual ' s name , social security number , or medical record number . by another establishment engaged in the manufacturing process , or you may assign a new code . If you assign a new code to an HCT / P , you must establish and maintain procedures for relating the new code to the old code .
( d ) Tracking from consignee to donor . As part of your tracking system , you must establish and maintain a method for recording the distinct identification code and type of each HCT / P distributed to a consignee to enable tracking from the consignee to the donor .
( e ) Tracking from donor to consignee or final disposition . As part of your tracking system , you must establish and maintain a method for documenting the disposition of each of your HCT / Ps , to enable tracking from the donor to the consignee or final disposition .
The information you maintain must permit the prompt identification of the consignee of the HCT / P , if any .
( f ) Consignees . At or before the time of distribution of an HCT / P to a consignee , you must inform the consignee in writing of the requirements in this section and of the tracking system that you have established and are maintaining to comply with these requirements .
( g ) Requirements specific to dura mater donors . You must archive appropriate specimens from each donor of dura mater , under appropriate storage conditions , and for the appropriate duration , to enable testing of the archived material for evidence of transmissible spongiform encephalopathy , and to enable appropriate disposition of any affected non-administered dura mater tissue , if necessary .
* Revised January 30 , 2017
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