Exemptions and consideration for certain drugs, devices, and biological products

The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.

( June 25, 1938, ch. 675, § 503 , 52 Stat. 1051 ; Oct. 26, 1951, ch. 578, § 1 , 65 Stat. 648 ; Pub. L. 87–781, title I, § 104(e)(2) , Oct. 10, 1962 , 76 Stat. 785 ; Pub. L. 91–601, § 6(e) , formerly § 7(e), Dec. 30, 1970 , 84 Stat. 1673 , renumbered Pub. L. 97–35, title XII, § 1205(c) , Aug. 13, 1981 , 95 Stat. 716 ; Pub. L. 100–293 , §§ 4–6, Apr. 22, 1988 , 102 Stat. 96–98 ; Pub. L. 100–670, title I, § 105 , Nov. 16, 1988 , 102 Stat. 3983 ; Pub. L. 101–629, § 16(a) , Nov. 28, 1990 , 104 Stat. 4526 ; Pub. L. 102–108, § 2(d) , Aug. 17, 1991 , 105 Stat. 550 ; Pub. L. 102–300, § 6(d) , June 16, 1992 , 106 Stat. 240 ; Pub. L. 102–353 , §§ 2(a)–(c), 4, Aug. 26, 1992 , 106 Stat. 941 , 942; Pub. L. 104–250, § 5(a) , Oct. 9, 1996 , 110 Stat. 3155 ; Pub. L. 105–115, title I , §§ 123(e), 126(a), (c)(1), (2), Nov. 21, 1997 , 111 Stat. 2324 , 2327, 2328; Pub. L. 107–250, title II, § 204 , Oct. 26, 2002 , 116 Stat. 1611 ; Pub. L. 108–282, title I, § 102(b)(5)(F) , Aug. 2, 2004 , 118 Stat. 903 ; Pub. L. 113–54, title II, § 204(a)(1) –(4), (b), Nov. 27, 2013 , 127 Stat. 630–635 ; Pub. L. 114–255, div. A, title III, § 3038(a) , Dec. 13, 2016 , 130 Stat. 1105 ; Pub. L. 117–328, div. FF, title III, § 3621 , Dec. 29, 2022 , 136 Stat. 5877 .)