21 C.F.R. § 1271.90 Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply?
Title 21 - Food and Drugs
(a) Donor-eligibility determination not required. You are not required to make a donor-eligibility determination under §1271.50 or to perform donor screening or testing under §§1271.75, 1271.80 and 1271.85 for: (1) Cells and tissues for autologous use; or (2) Reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use; or (3) Cryopreserved cells or tissue for reproductive use, other than embryos, originally exempt under paragraphs (a)(1) or (a)(2) of this section at the time of donation, that are subsequently intended for directed donation, provided that (i) Additional donations are unavailable, for example, due to the infertility or health of a donor of the cryopreserved reproductive cells or tissue; and (ii) Appropriate measures are taken to screen and test the donor(s) before transfer to the recipient. (4) A cryopreserved embryo, originally exempt under paragraph (a)(2) of this section at the time of cryopreservation, that is subsequently intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient. (b) Required labeling. As applicable, you must prominently label an HCT/P described in paragraph (a) of this section as follows: (1) “FOR AUTOLOGOUS USE ONLY,” if it is stored for autologous use. (2) “NOT EVALUATED FOR INFECTIOUS SUBSTANCES,” unless you have performed all otherwise applicable screening and testing under §§1271.75, 1271.80, and 1271.85. This paragraph does not apply to reproductive cells or tissue labeled in accordance with paragraph (b)(6) of this section. (3) Unless the HCT/P is for autologous use only, “WARNING: Advise recipient of communicable disease risks,” (i) When the donor-eligibility determination under §1271.50(a) is not performed or is not completed; or (ii) If the results of any screening or testing performed indicate: (A) The presence of relevant communicable disease agents and/or (B) Risk factors for or clinical evidence of relevant communicable disease agents or diseases. (4) With the Biohazard legend shown in §1271.3(h), if the results of any screening or testing performed indicate: (i) The presence of relevant communicable disease agents and/or (ii) Risk factors for or clinical evidence of relevant communicable disease agents or diseases. (5) “WARNING: Reactive test results for (name of disease agent or disease),” in the case of reactive test results. (6) “Advise recipient that screening and testing of the donor(s) were not performed at the time of cryopreservation of the reproductive cells or tissue, but have been performed subsequently,” for paragraphs (a)(3) or (a)(4) of this section. [69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005]
Title 21: Food and Drugs
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart C—Donor Eligibility
§ 1271.90 Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply?
