[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 728]
 
                        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.  1271.47  What procedures must I establish and maintain?

    (a) General. You must establish and maintain procedures for all 
steps that you perform in testing, screening, determining donor 
eligibility, and complying with all other requirements of this subpart. 
Establish and maintain means define, document (in writing or 
electronically), and implement; then follow, review, and as needed, 
revise on an ongoing basis. You must design these procedures to ensure 
compliance with the requirements of this subpart.
    (b) Review and approval. Before implementation, a responsible person 
must review and approve all procedures.
    (c) Availability. Procedures must be readily available to the 
personnel in the area where the operations to which they relate are 
performed, or in a nearby area if such availability is impractical.
    (d) Departures from procedures. You must record and justify any 
departure from a procedure relevant to preventing risks of communicable 
disease transmission at the time of its occurrence. You must not make 
available for distribution any HCT/P from a donor whose eligibility is 
determined under such a departure unless a responsible person has 
determined that the departure does not increase the risks of 
communicable disease transmission through the use of the HCT/P.
    (e) Standard procedures. You may adopt current standard procedures, 
such as those in a technical manual prepared by another organization, 
provided that you have verified that the procedures are consistent with 
and at least as stringent as the requirements of this part and 
appropriate for your operations.