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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR1271.75]
See Related Information on How do I screen a donor? in CDRH databases



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 C--Donor Eligibility

Sec. 1271.75 How do I screen a donor?

(a)All donors . Except as provided under 1271.90, if you are the establishment that performs donor screening, you must screen a donor of cells or tissue by reviewing the donor's relevant medical records for:

(1) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, including:

(i) Human immunodeficiency virus;

(ii) Hepatitis B virus;

(iii) Hepatitis C virus;

(iv) Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease;

(v)Treponema pallidum ; and

(2) Communicable disease risks associated with xenotransplantation.

(b)Donors of viable, leukocyte-rich cells or tissue . In addition to the relevant communicable disease agents and diseases for which screening is required under paragraph (a) of this section, and except as provided under 1271.90, you must screen the donor of viable, leukocyte-rich cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of relevant cell-associated communicable disease agents and diseases, including Human T-lymphotropic virus.

(c)Donors of reproductive cells or tissue . In addition to the relevant communicable disease agents and diseases for which screening is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under 1271.90, you must screen the donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of infection due to relevant communicable diseases of the genitourinary tract. Such screening must include screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section. However, if the reproductive cells or tissues are recovered by a method that ensures freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract, then screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section is not required. Communicable disease agents of the genitourinary tract for which you must screen include:

(1)Chlamydia trachomatis ; and

(2)Neisseria gonorrhea .

(d)Ineligible donors . You must determine ineligible a donor who is identified as having either of the following:

(1) A risk factor for or clinical evidence of any of the relevant communicable disease agents or diseases for which screening is required under paragraphs (a)(1), (b), or (c) of this section; or

(2) Any communicable disease risk associated with xenotransplantation.

(e)Abbreviated procedure for repeat donors . If you have performed a complete donor screening procedure on a living donor within the previous 6 months, you may use an abbreviated donor screening procedure on repeat donations. The abbreviated procedure must determine and document any changes in the donor's medical history since the previous donation that would make the donor ineligible, including relevant social behavior.

[66 FR 5466, Jan. 19, 2001, as amended at 71 FR 14798, Mar. 24, 2006]

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