[List of CFR Sections Affected (LSA), July 2016] [From the U.S. Government Publishing Office, www.gpo.gov] TITLE 21_FOOD AND DRUGS Chapter I_Food and Drug Administration, Department of Health and Human Services (Parts 1_1299) 1 Authority citation revised..........................16-20166, 16-45949 Policy statement..............................................16-39183 Nomenclature change...........................................16-49895 1.227 Amended...................................................16-45949 1.230 Revised...................................................16-45950 1.231 Revised...................................................16-45950 1.232 Revised...................................................16-45951 1.233 Revised...................................................16-45952 1.234 Revised...................................................16-45952 1.235 Revised...................................................16-45952 1.241 Revised...................................................16-45953 1.245 Added.....................................................16-45953 1.500 Amended...................................................16-25327 1.501 Heading revised...........................................16-25327 1.511 Heading, (a) heading and (b) heading revised 16-25327 1.512 (b)(3)(ii) introductory text and (c)(1)(i) amended; (b)(3)(iii) and (iv) revised.......................16-25327 1.900--1.934 (Subpart O) Added..................................16-20166 5 Nomenclature change...........................................16-49895 11.1 (n) added..................................................16-20170 (o) added.....................................................16-34218 14.1 (a)(2)(v) removed..........................................16-45409 14.100 (b)(5) redesignated as (b)(4); (b)(6) removed.....................................................16-37153 20.100 (c)(22) removed..........................................16-45409 56 Authority citation revised...................................16-19035 Regulation at 81 FR 19035 eff. date confirmed.................16-47288 56.120 (b)(4) and (c) redesignated as (c) and (d); (b) and new (c) revised.....................................16-19035 [[Page 42]] Regulation at 81 FR 19035 eff. date confirmed.................16-47288 70 Nomenclature change..........................................16-49895 71 Nomenclature change..........................................16-49895 73 Nomenclature change..........................................16-49895 80 Nomenclature change..........................................16-49895 100 Nomenclature change.........................................16-49895 101 Policy statement............................................16-43061 Nomenclature change...........................................16-49895 101.9 (c)(1)(ii), (j)(5)(ii)(C), (D), (E) and (13)(ii)(C) removed; (c)(1)(iii) and (j)(13)(ii)(D) redesignated as new (c)(1)(ii) and new (j)(13)(ii)(C); (c)(1)(i)(A) through (E), new (ii), (2), (5), (6)(i) through (4), (7), (8) introductory text, (i), (ii) introductory text, (iii), (iv), (v), (9), (d)(1) introductory text, (iii), (iv), (v), (2) through (5), (7) introductory text, (i), (8), (9), (11)(ii), (iii), (12), (13)(ii), (e), (f) introductory text, (2)(ii), (4), (5), (g) introductory text, (2), (3)(ii), (4), (5), (6), (8), (h)(3)(iv), (4) introductory text, (j)(5)(i), (ii) introductory text, (A), (B), (13)(i), (ii)(A)(1), (2), (B) and (18)(iv) introductory text revised; (c)(1)(i)(F), (8)(vii), (g)(10), (11), (j)(5)(iii) and (l) added.......................................................16-33979 (b)(2)(i)(D), (6), (8)(iii), (10)(ii) and (h)(3)(ii) revised; (b)(2)(i)(E) removed; (b)(2)(i)(F) through (I) redesignated as new (b)(2)(i)(E) through (H); (b)(12) added.....................16-34040 101.12 (f)(2) removed; (f)(3) redesignated as new (f)(2); (b) tables 1 and 2, (c), (f)(1) and new (2) revised.............................................16-34041 101.30 (e)(2) revised...........................................16-33994 101.36 (b)(2)(i) introductory text, (B), (ii)(A), (B), (iii) introductory text, (D) through (G), (3)(ii)(A), (c)(4), (e) introductory text, (8), (11)(i) through (viii), (12), (f) and (i)(1) revised; (i) introductory text removed 16-33994 102 Nomenclature change.........................................16-49895 106 Policy statement............................................16-22174 Nomenclature change...........................................16-49895 107 Nomenclature change.........................................16-49895 108 Nomenclature change.........................................16-49896 108.25 (c)(1) and (2) revised...................................16-46831 108.35 (c)(1), (2) introductory text, (ii) and (i) revised.....................................................16-46831 109 Nomenclature change.........................................16-49896 110 Nomenclature change.........................................16-49896 112 Nomenclature change.........................................16-49896 112.3 (a), (b) and (c) introductory text removed; introductory text added; amended............................16-26467 112.55 (b) revised..............................................16-26468 117 Nomenclature change.........................................16-49896 118 Nomenclature change.........................................16-49896 121 Added.......................................................16-34219 130 Nomenclature change.........................................16-49896 161 Nomenclature change.........................................16-49896 170 Nomenclature change.........................................16-49896 171 Nomenclature change.........................................16-49896 172 Nomenclature change.........................................16-49896 172.345 (b) amended; (i) added..................................16-22183 172.379 (b) amended; (c) table revised..........................16-46581 172.380 (b) amended; (c)(8) added...............................16-46582 173 Nomenclature change.........................................16-49896 175 Nomenclature change.........................................16-49896 176 Nomenclature change.........................................16-49896 177 Nomenclature change.........................................16-49896 178 Nomenclature change.........................................16-49896 180 Nomenclature change.........................................16-49896 181 Nomenclature change.........................................16-49896 184 Nomenclature change.........................................16-49897 189 Nomenclature change.........................................16-49897 190 Nomenclature change.........................................16-49897 211 Nomenclature change.........................................16-49897 507 Nomenclature change.........................................16-49897 510.600 (c)(1) table and (2) table amended............16-36788, 16-48702 514 Authority citation revised..................................16-29141 514.80 (b)(4) introductory text amended; (b)(4)(i) revised.....................................................16-29141 514.87 Added....................................................16-29141 520 Drug application approvals withdrawn........................16-36790 520.110 (b) amended.............................................16-48702 520.1084 Added..................................................16-36789 520.1430 Heading revised........................................16-36789 520.1696b (b) amended...........................................16-36789 520.2130 (b) amended............................................16-48702 520.2134 (b) amended............................................16-48702 520.2261a (b) amended...........................................16-36789 520.2325a (a)(2) removed; (a)(3) and (4) redesignated as new (a)(2) and (3)..........................16-36789 520.2471 (b) amended............................................16-48702 520.2640 (b)(1) amended.........................................16-48702 [[Page 43]] 522.150 (b) amended.............................................16-48702 522.690 (b)(3) amended..........................................16-36789 522.840 (b) amended.............................................16-48702 522.842 (a)(2) amended..........................................16-48702 522.1077 (b)(3) amended.........................................16-36789 522.1680 (b) amended............................................16-36789 522.1684 Added..................................................16-36789 (b) amended...................................................16-48702 522.1940 (a)(2) amended.........................................16-48702 522.2005 (b)(1) amended.........................................16-36789 522.2112 (b) amended............................................16-48702 522.2471 (b) amended............................................16-48703 522.2476 (a)(1) amended.........................................16-48703 522.2477 (b)(1) amended.........................................16-48703 522.2640 (b)(1) amended.........................................16-48703 524.916 (b) amended.............................................16-48703 524.1044g (b)(3) correctly amended..............................16-18749 524.1193 (b)(2) correctly amended...............................16-25328 524.1445 (b) amended............................................16-48703 524.1484k Heading correctly revised.............................16-25328 556.748 (c) revised.............................................16-36789 558 Drug application approvals withdrawn........................16-36790 558.4 (d) table amended.........................................16-36790 558.68 (b) amended..............................................16-48703 558.248 (a) and (b) revised; (d)(1)(iii) removed 16-36790 558.274 (a)(1), (c)(1)(i), (ii), (2)(i) and (ii) amended.....................................................16-48703 558.342 (b)(2), (e)(1)(i) through (iv), (ix) and (x) amended.................................................16-48703 558.355 (b)(1), (2), (4) through (9), (11), (12), (14), (f)(1)(xiii)(b), (xxi)(b), (xxii)(b), (xxviii)(b), (xxix)(b), (xxxi)(b), (3)(i)(b)(2)(iii), (ii)(b), (xii)(b), (4)(ii)(b), (iii)(b) and (6)(i)(b)(2)(iii) amended.....................................................16-48703 558.363 (a)(1), (3), (8), (d)(1)(ii)(B), (iii)(B), (iv)(B), (v)(B) and (vi)(B) amended.........................16-48703 558.366 (b) and (d) amended.....................................16-48703 558.500 (b), (e)(1)(i) through (iv), (2)(i) through (xiii) and (3)(i) through (iv) amended 16-48703 558.550 (d)(1)(xxii)(B) amended.................................16-48703 558.618 (b), (e)(1)(i) and (2)(i) amended.......................16-48703 558.625 (b)(3) removed; (b)(4) and (5) redesignated as new (b)(3) and (4)..........................16-36790 (b)(1) amended................................................16-48703 558.630 (b)(1) amended..........................................16-48703 558.633 Added...................................................16-36790 558.665 (e)(2) through (6), (8), (10), (11) and (12) amended................................................16-48703 573.304 Added...................................................16-35611 Regulation at 81 FR 35611 eff. date confirmed; comment period extended.....................................16-41441 610.20--610.21 (Subpart C) Removed..............................16-26691 610.50 Revised..................................................16-26691 610.53 Revised..................................................16-26691 660.2 (c) revised...............................................16-38924 660.20 (a) revised..............................................16-38925 660.28 Revised..................................................16-38925 660.35 Revised..................................................16-38926 660.45 Revised..................................................16-38928 660.50 (a) revised..............................................16-38928 660.55 Revised..................................................16-38928 701 Nomenclature change.........................................16-49897 710 Nomenclature change.........................................16-49897 720 Nomenclature change.........................................16-49897 801 Authority citation revised..................................16-38930 801.15 Heading and (c)(1) revised...............................16-38930 801.109 (b)(1) revised..........................................16-38930 809.10 (a)(4) and (b)(5)(ii) amended; (g) added.................16-38931 870.5200 Revised................................................16-33133 870.5210 Added..................................................16-33134 876.5011 Added..................................................16-45231 878.4420 Added..................................................16-42244 882.5700 Added..................................................16-44772 884.4050 Added..................................................16-40183 886.1925 Added..................................................16-34270 886.5838 Added..................................................16-37500 890.5525 (b) revised; (c) removed...............................16-48706 1100 Added......................................................16-29102 1140 Heading revised............................................16-29102 1140.1 Revised..................................................16-29102 1140.2 Revised..................................................16-29102 1140.3 Revised..................................................16-29102 1140.10 Revised.................................................16-29103 1140.14 Revised.................................................16-29103 1143 Added......................................................16-29103 1150 Authority citation revised.................................16-28715 1150.3 Amended..................................................16-28715 1150.5 (a) amended; (c) and (d) added...........................16-28715 1150.7 (a)(1) revised; (a)(2) added.............................16-28716 1150.9 (a)(1) revised; (a)(2) added.............................16-28716 1250 Nomenclature change........................................16-49897 1271.90 (b) redesignated as (c); new (b) added; heading, (a)(3) [[Page 44]] introductory text, (4), new (c) introductory text, (2) and (6) revised...................................16-40517 1271.370 (b)(4) amended.........................................16-40518 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1308.11 (b)(3) through (55) redesignated as (b)(4) through (56); new (b)(3) added..............................16-22025 (d)(48), (49) and (50) added; (h)(1), (2) and (3) removed; (h)(4) through (25) redesignated as new (h)(1) through (22)..................................16-29145 (h)(26) and (27) added........................................16-29496 1308.15 (e)(1), (2) and (3) redesignated as (e)(2), (3) and (4); new (e)(1) added; interim 16-29491 Proposed Rules: 1.....................................................16-28035, 16-43155 11....................................................16-27067, 16-28035 16..............................................................16-28035 56..............................................................16-19066 101.............................................................16-27067 111.............................................................16-28035 117.............................................................16-30219 172.............................................................16-38984 175...................................................16-31877, 16-37561 176.........................................16-25625, 16-31877, 16-37561 177.........................................16-31877, 16-37561, 16-42585 178...................................................16-31877, 16-37561 310.............................................................16-42912 330.............................................................16-19069 507.............................................................16-30219 610.............................................................16-26753 820.............................................................16-24041 882...................................................16-24386, 16-32258 895...................................................16-24386, 16-32258 1005............................................................16-43155 1100........................................16-28778, 16-28780, 16-28781 1140........................................16-28778, 16-28780, 16-28781 1143........................................16-28778, 16-28780, 16-28781 1150............................................................16-28783 1271........................................16-23661, 16-23664, 16-43155