e-CFR data is current as of February 23, 2021 |
Amendment
Effective Dates: Jan. 20, 2021
26. In §173.134, revise paragraphs (b)(7), (b)(12)(ii)(C), and (b)(16) to read as follows:
(b) * * *
(7) Blood collected for the purpose of blood transfusion or the preparation of blood products; blood products; plasma; plasma derivatives; blood components; tissues or organs intended for use in transplant operations; and human cell, tissues, and cellular and tissue-based products regulated under authority of the Public Health Service Act (42 U.S.C. 264-272) and/or the Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(12) * * *
(ii) * * *
(C) The secondary container must be placed inside an outer packaging with sufficient cushioning material to prevent shifting between the secondary container and the outer packaging. An itemized list of the contents of the primary container and information concerning possible contamination with a Division 6.2 material, including its possible location on the product, must be placed between the secondary container and the outside packaging.
(16) A raw agricultural commodity as defined in the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 301 et seq.).