[List of CFR Sections Affected (LSA), August 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, 16-57784 Nomenclature change...........................................16-49895 1.1 (c) amended.................................................16-59131 1.20 Amended....................................................16-59131 1.24 Amended....................................................16-59131 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 Policy statement...................................16-54499, 16-57784 11.1 (n) added..................................................16-20170 (o) added.....................................................16-34218 14.1 (a)(2)(v) removed..........................................16-45409 [[Page 47]] 14.100 (b)(5) redesignated as (b)(4); (b)(6) removed.....................................................16-37153 16 Policy statement.............................................16-57784 16.1 (b)(1) and (2) amended.....................................16-52995 20.100 (c)(22) removed..........................................16-45409 (c)(46) added.................................................16-55046 (c)(9) amended................................................16-60212 20.116 Revised..................................................16-60212 25.20 (k) revised...............................................16-55047 25.32 (f), (i), (j), (k) and (r) revised........................16-55047 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 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 100.155 (a) and (b) amended.....................................16-59131 101 Policy statement........................16-43061, 16-54499, 16-54501 Nomenclature change...........................................16-49895 101.2 (c) introductory text amended.............................16-59131 101.7 Redesignated from 101.105; heading revised 16-59131 101.8 Regulation at 79 FR 71291 compliance date extended in part to 7-26-18.................................16-50303 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 101.13 (d)(2), (h)(4)(i) and (i)(2) amended.....................16-59131 101.30 (e)(2) revised...........................................16-33994 (g) amended...................................................16-59131 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 101.105 Redesignated as 101.7...................................16-59131 102 Nomenclature change.........................................16-49895 104.5 (b) amended...............................................16-59131 106 Policy statement..................................16-22174, 16-57784 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 Policy statement..............................................16-57784 111 Policy statement............................................16-57784 112 Nomenclature change.........................................16-49896 Policy statement..............................................16-57784 112.3 (a), (b) and (c) introductory text removed; introductory text added; amended............................16-26467 112.55 (b) revised..............................................16-26468 114 Policy statement............................................16-57784 117 Nomenclature change.........................................16-49896 Policy statement..............................................16-57784 118 Nomenclature change.........................................16-49896 120 Policy statement............................................16-57784 121 Added.......................................................16-34219 123 Policy statement............................................16-57784 129 Policy statement............................................16-57784 130 Nomenclature change.........................................16-49896 161 Nomenclature change.........................................16-49896 170 Nomenclature change.........................................16-49896 [[Page 48]] 170.3 (h) and (k) revised; (i) amended..........................16-55047 170.30 (a), (c)(1), (d), (h) introductory text, (1), (i), (j), (k) and (l) amended; (b), (c)(2) and (e) revised; (f) removed.........................16-55047 170.35 (a), (b)(1), (3) and (4) revised; (c) removed.....................................................16-55048 170.38 (a) revised..............................................16-55048 170.203--170.285 (Subpart E) Added..............................16-55048 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 179 Policy statement............................................16-57784 180 Nomenclature change.........................................16-49896 181 Nomenclature change.........................................16-49896 184 Nomenclature change.........................................16-49897 184.1 (a) and (b)(1) amended....................................16-55051 186.1 (a) and (b)(1) amended....................................16-55051 189 Nomenclature change.........................................16-49897 190 Nomenclature change.........................................16-49897 201.1 (f) amended...............................................16-60212 201.2 Amended...................................................16-60212 201.25 (c)(1) introductory text amended.........................16-60212 207 Revised.....................................................16-60212 211 Nomenclature change.........................................16-49897 Policy statement..............................................16-57784 314.81 (b)(3)(iv) revised.......................................16-60221 314.125 (b)(11) amended.........................................16-60221 507 Nomenclature change.........................................16-49897 Policy statement..............................................16-57784 510.600 (c)(1) table and (2) table amended...........16-36788, 16-48702, 16-59133 514 Authority citation revised..................................16-29141 514.80 (b)(4) introductory text amended; (b)(4)(i) revised.....................................................16-29141 514.87 Added....................................................16-29141 514.111 (a)(12) added...........................................16-60221 514.200 Revised.................................................16-52997 515.10 (b)(8) amended...........................................16-60221 520 Drug application approvals withdrawn........................16-36790 520.100 (b)(3) and (4) removed..................................16-59133 520.110 (b) amended.............................................16-48702 520.284 Redesignated from 520.300...............................16-59133 520.284a Redesignated from 520.300a.............................16-59133 520.284b Redesignated from 520.300b.............................16-59133 520.284c Redesignated from 520.300c.............................16-59133 520.292 Added...................................................16-59133 520.300 Redesignated as 520.284.................................16-59133 520.300a Redesignated as 520.284a...............................16-59133 520.300b Redesignated as 520.284b...............................16-59133 520.300c Redesignated as 520.284c...............................16-59133 520.1084 Added..................................................16-36789 520.1430 Heading revised........................................16-36789 520.1696b (b) amended...........................................16-36789 520.2075 (a) and (c) revised....................................16-59133 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 (a)(3) amended................................................16-59134 520.2471 (b) amended............................................16-48702 520.2640 (b)(1) amended.........................................16-48702 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 522.1055 Revised................................................16-59134 522.1077 (b)(3) amended.........................................16-36789 522.1182 (b) introductory text, (7) introductory text, (i) and (ii) amended..................................16-59134 522.1192 (b)(2) amended.........................................16-59134 522.1260 (b)(2) amended.........................................16-59134 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 524.1044h (a) and (b) revised...................................16-59134 524.1193 (b)(2) correctly amended...............................16-25328 [[Page 49]] 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, 16-59135 558.3 (b)(1)(i) and (ii) revised; (b)(13) and (14) added.......................................................16-57800 558.4 (d) tables amended..............................16-36790, 16-59134 558.68 (b) amended..............................................16-48703 (a) and (e) revised...........................................16-59134 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 (c)(1)(ii) and (2)(ii) removed................................16-59135 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 (f)(1)(xxviii) removed; (f)(8)(i) and (ii) revised.....................................................16-59135 558.363 (a)(1), (3), (8), (d)(1)(ii)(B), (iii)(B), (iv)(B), (v)(B) and (vi)(B) amended.........................16-48703 (d)(1)(vi) removed............................................16-59135 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 (d)(1)(xxii) removed..........................................16-59135 558.618 (b), (e)(1)(i) and (2)(i) amended.......................16-48703 (e)(2)(ii) and (iii) amended..................................16-59135 558.625 (b)(3) removed; (b)(4) and (5) redesignated as new (b)(3) and (4)..........................16-36790 (b)(1), (f)(2)(i), (iii) and (vii) revised; (f)(2)(viii) and (ix) removed...............................16-59135 (b)(1) amended................................................16-48703 558.630 (b)(1) amended..........................................16-48703 (b)(1) revised................................................16-59135 558.633 Added...................................................16-36790 558.665 (e)(2) through (6), (8), (10), (11) and (12) amended................................................16-48703 570.3 (f), (h) and (k) revised; (i) amended; (n) added.......................................................16-55051 570.30 (a) and (i) amended; (b), (c) and (d) revised.....................................................16-55052 570.35 (a), (b)(1), (3) and (4) revised; (c) removed.....................................................16-55052 570.38 (a) revised..............................................16-55052 570.203--570.280 (Subpart E) Added..............................16-55052 573.304 Added...................................................16-35611 Regulation at 81 FR 35611 eff. date confirmed; comment period extended.....................................16-41441 601.2 (f) added.................................................16-60221 607 Heading revised.............................................16-60221 607.1 Added.....................................................16-60221 607.3 (b) amended; (k) and (l) added............................16-60222 607.7 Revised...................................................16-60222 607.20 (c) amended..............................................16-60222 607.21 Amended..................................................16-60222 607.22 Revised..................................................16-60222 607.25 Revised..................................................16-60222 607.26 Amended..................................................16-60222 607.30 (a) introductory text revised............................16-60222 607.35 Revised..................................................16-60223 607.37 Revised..................................................16-60223 607.39 Revised..................................................16-60223 607.40 (d) introductory text and (3) revised; (e) added.......................................................16-60223 607.65 (g) added................................................16-60223 607.80 (Subpart E) Added........................................16-60223 610.20--610.21 (Subpart C) Removed..............................16-26691 Regulation at 81 FR 26691 eff. date confirmed.................16-52329 610.50 Revised..................................................16-26691 Regulation at 81 FR 26691 eff. date confirmed.................16-52329 610.53 Revised..................................................16-26691 Regulation at 81 FR 26691 eff. date confirmed.................16-52329 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 [[Page 50]] 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 1105 Added......................................................16-52334 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 1271.1 (a) and (b)(2) amended...................................16-60223 1271.3 (mm) and (nn) added......................................16-60223 1271.20 Amended.................................................16-60223 1271.22 Revised.................................................16-60223 1271.23 Added...................................................16-60224 1271.25 (a) introductory text, (2), (3) and (c)(4) revised; (a)(5), (6) and (d) added..........................16-60224 1271.26 Revised.................................................16-60224 1271.90 (b) redesignated as (c); new (b) added; heading, (a)(3) 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) 1301 Policy statement...........................................16-53846 1301.74 (g) revised; interim....................................16-58839 1301.75 (e) revised; interim....................................16-58839 1305.07 Introductory text and (a) revised; interim 16-58839 1305.17 (d) revised; interim....................................16-58839 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 1308.12 (c)(29) added; interim..................................16-58839 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, 16-57812, 16-58342 56..............................................................16-19066 58..............................................................16-58342 101.............................................................16-27067 111.............................................................16-28035 117.........................................16-30219, 16-57816, 16-58421 172.............................................................16-38984 175.........................................16-31877, 16-37561, 16-52370 176...............................16-25625, 16-31877, 16-37561, 16-52370 177...............................16-31877, 16-37561, 16-42585, 16-52370 178.........................................16-31877, 16-37561, 16-52370 310.............................................................16-42912 330.............................................................16-19069 507...................................................16-30219, 16-58421 511.............................................................16-57812 558.............................................................16-57818 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 1105............................................................16-52371 1140........................................16-28778, 16-28780, 16-28781 1143........................................16-28778, 16-28780, 16-28781 1150............................................................16-28783 1271........................................16-23661, 16-23664, 16-43155 1300--1399 (Ch. II)...................................16-53688, 16-53767 1308............................................................16-59929