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21 U.S.C. 351, 352, 360b, 371, 374.
40 FR 14031, Mar. 27, 1975, unless otherwise noted.
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The key personnel and any consultants involved in the manufacture and control of the Type A medicated article(s) shall have a background of appropriate education or appropriate experience or combination thereof for assuming responsibility to assure that the Type A medicated article(s) has the proper labeling and the safety, identity, strength, quality, and purity that it purports to possess.