[List of CFR Sections Affected (LSA), October 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................................20166, 45949 Policy statement..........................................39183, 57784 Nomenclature change..............................................49895 1.1 (c) amended....................................................59131 1.20 Amended.......................................................59131 1.24 Amended.......................................................59131 1.227 Amended......................................................45949 1.230 Revised......................................................45950 1.231 Revised......................................................45950 1.232 Revised......................................................45951 1.233 Revised......................................................45952 1.234 Revised......................................................45952 1.235 Revised......................................................45952 1.241 Revised......................................................45953 1.245 Added........................................................45953 1.500 Amended......................................................25327 1.501 Heading revised..............................................25327 1.511 Heading, (a) heading and (b) heading revised 25327 1.512 (b)(3)(ii) introductory text and (c)(1)(i) amended; (b)(3)(iii) and (iv) revised..........................25327 1.900--1.934 (Subpart O) Added.....................................20166 2.125 (e)(4)(vi) and (ix) removed..................................74302 5 Nomenclature change..............................................49895 11 Policy statement.........................................54499, 57784 11.1 (n) added.....................................................20170 (o) added........................................................34218 14.1 (a)(2)(v) removed.............................................45409 14.100 (b)(5) redesignated as (b)(4); (b)(6) removed........................................................37153 16 Policy statement................................................57784 16.1 (b)(1) and (2) amended........................................52995 17.2 Revised.......................................................62358 20.100 (c)(22) removed.............................................45409 (c)(46) added....................................................55046 (c)(9) amended...................................................60212 [[Page 56]] Regulation at 81 FR 55046 eff. date corrected....................62004 20.116 Revised.....................................................60212 25.20 (k) revised..................................................55047 Regulation at 81 FR 55047 eff. date corrected....................62004 25.32 (f), (i), (j), (k) and (r) revised...........................55047 Regulation at 81 FR 55047 eff. date corrected....................62004 56 Authority citation revised......................................19035 Regulation at 81 FR 19035 eff. date confirmed....................47288 56.120 (b)(4) and (c) redesignated as (c) and (d); (b) and new (c) revised........................................19035 Regulation at 81 FR 19035 eff. date confirmed....................47288 70 Nomenclature change.............................................49895 71 Nomenclature change.............................................49895 73 Nomenclature change.............................................49895 80 Nomenclature change.............................................49895 100 Nomenclature change............................................49895 100.155 (a) and (b) amended........................................59131 101 Policy statement..........................43061, 54499, 54501, 66527 Nomenclature change..............................................49895 101.2 (c) introductory text amended................................59131 101.7 Redesignated from 101.105; heading revised 59131 101.8 Regulation at 79 FR 71291 compliance date extended in part to 7-26-18....................................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..........................................................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........................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................................................34041 101.13 (d)(2), (h)(4)(i) and (i)(2) amended........................59131 101.30 (e)(2) revised..............................................33994 (g) amended......................................................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 33994 101.105 Redesignated as 101.7......................................59131 102 Nomenclature change............................................49895 104.5 (b) amended..................................................59131 106 Policy statement........................................22174, 57784 Nomenclature change..............................................49895 107 Nomenclature change............................................49895 108 Nomenclature change............................................49896 108.25 (c)(1) and (2) revised......................................46831 108.35 (c)(1), (2) introductory text, (ii) and (i) revised........................................................46831 109 Nomenclature change............................................49896 110 Nomenclature change............................................49896 Policy statement.................................................57784 111 Policy statement...............................................57784 112 Nomenclature change............................................49896 Policy statement.................................................57784 112.3 (a), (b) and (c) introductory text removed; introductory text added; amended...............................26467 112.55 (b) revised.................................................26468 114 Policy statement...............................................57784 117 Nomenclature change............................................49896 Policy statement.................................................57784 117.3 Regulation at 80 FR 56145 eff. date confirmed in part..............................................64060 118 Nomenclature change............................................49896 120 Policy statement...............................................57784 121 Added..........................................................34219 123 Policy statement...............................................57784 129 Policy statement...............................................57784 130 Nomenclature change............................................49896 [[Page 57]] 161 Nomenclature change............................................49896 170 Nomenclature change............................................49896 170.3 (h) and (k) revised; (i) amended.............................55047 Regulation at 81 FR 55047 eff. date corrected....................62004 170.30 (a), (c)(1), (d), (h) introductory text, (1), (i), (j), (k) and (l) amended; (b), (c)(2) and (e) revised; (f) removed............................55047 Regulation at 81 FR 55047 eff. date corrected....................62004 170.35 (a), (b)(1), (3) and (4) revised; (c) removed........................................................55048 Regulation at 81 FR 55048 eff. date corrected....................62004 170.38 (a) revised.................................................55048 Regulation at 81 FR 55048 eff. date corrected....................62004 170.203--170.285 (Subpart E) Added.................................55048 Regulation at 81 FR 55048 eff. date corrected....................62004 171 Nomenclature change............................................49896 172 Nomenclature change............................................49896 172.345 (b) amended; (i) added.....................................22183 172.379 (b) amended; (c) table revised.............................46581 172.380 (b) amended; (c)(8) added..................................46582 173 Nomenclature change............................................49896 175 Nomenclature change............................................49896 176 Nomenclature change............................................49896 177 Nomenclature change............................................49896 178 Nomenclature change............................................49896 179 Policy statement...............................................57784 180 Nomenclature change............................................49896 181 Nomenclature change............................................49896 184 Nomenclature change............................................49897 184.1 (a) and (b)(1) amended.......................................55051 Regulation at 81 FR 55051 eff. date corrected....................62004 186.1 (a) and (b)(1) amended.......................................55051 Regulation at 81 FR 55051 eff. date corrected....................62004 189 Nomenclature change............................................49897 190 Nomenclature change............................................49897 201.1 (f) amended..................................................60212 201.2 Amended......................................................60212 201.25 (c)(1) introductory text amended............................60212 207 Revised........................................................60212 211 Nomenclature change............................................49897 Policy statement.................................................57784 216 Heading and authority citation revised.........................69676 216.24 Revised.....................................................69676 310 Authority citation revised.....................................61129 310.545 (a)(27)(iii), (iv) and (d)(41) added; (d) introductory text amended......................................61129 314 Authority citation revised.....................................69636 314.3 Revised......................................................69636 314.50 (a) introductory text, (5), (b), (c)(1), (2)(i), (iv) through (viii), (d) introductory text, (1)(i), (ii)(a), (iii), (iv), (v), (3)(ii), (5)(iv), (v), (vi)(a), (b), (e)(1)(i) introductory text, (2) introductory text, (f) introductory text, (1), (2), (3), (g)(2), (h), (j) introductory text, (3), (4) introductory text, (i), (ii), (iii), (k), (l) heading, (1) introductory text and (4) amended; heading, introductory text, (a)(1), (e)(1) introductory text, (f)(4), (g)(3), (i), (l)(2) and (3) revised........................................................69639 314.52 Revised.....................................................69641 314.53 Revised.....................................................69643 314.54 (a)(1) introductory text, (i) and (3) amended; heading, (a) introductory text, (1)(iii), (v), (vi), (2), (4) and (b) revised 69647 314.60 Amended; (b)(1), (4), (c)(1)(i) and (2) amended; (b) heading, (c) heading, (e) and (f) added; heading, (a), (c)(1)(iii) and (d) revised........................................................69648 314.70 (a) heading, (1)(i), (ii), (6), (b)(2)(i), (viii), (4), (c)(6) introductory text, (7), (d)(2)(v), (vi), (vii), (3)(i) and (e) amended; heading, (a)(2) and (f) revised; (h) added..........................................................69648 314.81 (b)(3)(iv) revised..........................................60221 314.90 Amended; (c) added..........................................69649 314.93 (a), (b), (c), (d)(3), (e)(1)(iii)(C), (v) and (3) amended; (f) redesignated as (f)(1); (e)(1)(vi) and (f)(2) added....................................69649 314.94 (a) introductory text, (1), (5)(ii)(A), (6)(ii), (7)(i), (ii) introductory text, (C), (8)(i), (iv), (9)(ii) through (v), (12)(i)(A)(1) through (4), (13), (b), (d)(1)(i), (4) and (5) amended; (a)(12)(iv) removed; [[Page 58]] heading, introductory text, (a) heading, (2), (3), (7)(iii), (9)(i), (12)(i) heading, (A) introductory text, (4), (B), (ii) through (viii), (d) heading, (1) introductory text and (2) revised....................................................69649 314.95 Revised.....................................................69651 314.96 Heading revised; (a) heading, (1) and (b) amended; (b) heading, (c) and (d) added........................69652 314.97 Revised.....................................................69653 314.99 Revised.....................................................69653 314.101 Revised....................................................69653 314.105 Revised....................................................69654 314.107 Revised....................................................69655 314.108 (a) introductory text, (b) heading and (2) through (5) revised; (a) amended...............................69657 314.125 (b)(11) amended............................................60221 (a) introductory text, (2), (b)(2), (7), (9), (10), (11), (12) and (14) through (18) amended; heading and (b) introductory text revised; (b)(19) added.........................................69658 314.127 (a) introductory text, (3) through (7), (3)(iii)(A)(2), (8)(ii)(A) introductory text, (9), (10), (12) and (b) amended; heading, (a) introductory text, (2), (8)(i) introductory text, (ii)(B) and (C) revised; (a)(14) added 69658 320.1 Revised......................................................69658 320.23 (a)(1) and (2) amended; (b) redesignated as (b)(1); (b)(2) added...........................................69658 507 Nomenclature change............................................49897 Policy statement.................................................57784 507.3 Regulation at 80 FR 56337 eff. date confirmed in part..............................................64060 510.600 (c)(1) table and (2) table amended....36788, 48702, 59133, 67151 514 Authority citation revised.....................................29141 514.80 (b)(4) introductory text amended; (b)(4)(i) revised........................................................29141 514.87 Added.......................................................29141 514.111 (a)(12) added..............................................60221 514.200 Revised....................................................52997 515.10 (b)(8) amended..............................................60221 520 Drug application approvals withdrawn...........................36790 520.100 (b)(3) and (4) removed.....................................59133 520.110 (b) amended................................................48702 520.284 Redesignated from 520.300..................................59133 520.284a Redesignated from 520.300a................................59133 520.284b Redesignated from 520.300b................................59133 520.284c Redesignated from 520.300c................................59133 520.292 Added......................................................59133 520.300 Redesignated as 520.284....................................59133 520.300a Redesignated as 520.284a..................................59133 520.300b Redesignated as 520.284b..................................59133 520.300c Redesignated as 520.284c..................................59133 520.928 (c) revised................................................67151 520.1084 Added.....................................................36789 520.1430 Heading revised...........................................36789 520.1696b (b) amended..............................................36789 520.2075 (a) and (c) revised.......................................59133 520.2130 (b) amended...............................................48702 520.2134 (b) amended...............................................48702 520.2261a (b) amended..............................................36789 520.2325a (a)(2) removed; (a)(3) and (4) redesignated as new (a)(2) and (3).............................36789 (a)(3) amended...................................................59134 520.2345c (d)(1)(iii) removed......................................67151 520.2471 (b) amended...............................................48702 520.2640 (b)(1) amended............................................48702 522.150 (b) amended................................................48702 522.224 Added......................................................67151 522.690 (b)(3) amended.............................................36789 522.840 (b) amended................................................48702 522.842 (a)(2) amended.............................................48702 522.1055 Revised...................................................59134 522.1077 (b)(3) amended............................................36789 522.1182 (b) introductory text, (7) introductory text, (i) and (ii) amended.....................................59134 522.1192 (b)(2) amended............................................59134 522.1260 (b)(2) amended............................................59134 522.1680 (b) amended...............................................36789 522.1684 Added.....................................................36789 (b) amended......................................................48702 522.1870 (a), (c)(1)(i), (iii), (2)(i) and (iii) revised........................................................67151 522.1940 (a)(2) amended............................................48702 522.2005 (b)(1) amended............................................36789 522.2112 (b) amended...............................................48702 522.2471 (b) amended...............................................48703 522.2476 (a)(1) amended............................................48703 522.2477 (b)(1) amended............................................48703 522.2630 (d)(1)(iii)(A) revised....................................67151 522.2640 (b)(1) amended............................................48703 [[Page 59]] Revised..........................................................67151 524.916 (b) amended................................................48703 524.998 Added......................................................67152 524.1044g (b)(3) correctly amended.................................18749 524.1044h (a) and (b) revised......................................59134 524.1193 (b)(2) correctly amended..................................25328 524.1445 (b) amended...............................................48703 524.1484k Heading correctly revised................................25328 529.400 (a) footnote 1 removed.....................................67152 556.748 (c) revised................................................36789 558 Drug application approvals withdrawn....................36790, 59135 558.3 (b)(1)(i) and (ii) revised; (b)(13) and (14) added..........................................................57800 558.4 (d) tables amended....................................36790, 59134 558.58 (e)(6) amended..............................................67152 558.59 Revised.....................................................67152 558.68 (b) amended.................................................48703 (a) and (e) revised..............................................59134 (c) and (d) redesignated as (d) and (c); (e)(1)(i) and (2)(i) amended...................................67152 558.128 (e)(7)(xi) amended.........................................67152 558.140 (b)(2) amended.............................................63054 558.145 (a)(2) removed.............................................63054 558.195 (e)(1)(vi), (2)(iii) and (v) amended.......................67152 558.248 (a) and (b) revised; (d)(1)(iii) removed 36790 558.261 (c) and (d) redesignated as (d) and (c)....................67152 558.274 (a)(1), (c)(1)(i), (ii), (2)(i) and (ii) amended........................................................48703 (c)(1)(ii) and (2)(ii) removed...................................59135 558.295 (b) removed................................................67152 558.325 (d)(3) revised.............................................67152 558.342 (b)(2), (e)(1)(i) through (iv), (ix) and (x) amended....................................................48703 (e)(1)(iv), (ix), (x) and (xi) amended...........................67152 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........................................................48703 (f)(1)(xxviii) removed; (f)(8)(i) and (ii) revised........................................................59135 558.363 (a)(1), (3), (8), (d)(1)(ii)(B), (iii)(B), (iv)(B), (v)(B) and (vi)(B) amended............................48703 (d)(1)(vi) removed...............................................59135 558.366 (b) and (d) amended........................................48703 (d) amended......................................................67153 558.500 (b), (e)(1)(i) through (iv), (2)(i) through (xiii) and (3)(i) through (iv) amended 48703 558.550 (d)(1)(xxii)(B) amended....................................48703 (d)(1)(xxii) removed.............................................59135 558.618 (b), (e)(1)(i) and (2)(i) amended..........................48703 (e)(2)(ii) and (iii) amended.....................................59135 (c) and (d) redesignated as (d) and (c)..........................67153 558.625 (b)(3) removed; (b)(4) and (5) redesignated as new (b)(3) and (4).............................36790 (b)(1), (f)(2)(i), (iii) and (vii) revised; (f)(2)(viii) and (ix) removed..................................59135 (b)(1) amended...................................................48703 558.630 (b)(1) amended.............................................48703 (b)(1) revised...................................................59135 558.633 Added......................................................36790 (d)(1) revised...................................................67153 558.665 (e)(2) through (6), (8), (10), (11) and (12) amended...................................................48703 570.3 (f), (h) and (k) revised; (i) amended; (n) added..........................................................55051 Regulation at 81 FR 55051 eff. date corrected....................62004 570.30 (a) and (i) amended; (b), (c) and (d) revised........................................................55052 Regulation at 81 FR 55052 eff. date corrected....................62004 570.35 (a), (b)(1), (3) and (4) revised; (c) removed........................................................55052 Regulation at 81 FR 55052 eff. date corrected....................62004 570.38 (a) revised.................................................55052 Regulation at 81 FR 55052 eff. date corrected....................62004 570.203--570.280 (Subpart E) Added.................................55052 Regulation at 81 FR 55052 eff. date corrected....................62004 573.304 Added......................................................35611 Regulation at 81 FR 35611 eff. date confirmed; comment period extended........................................41441 573.696 Added......................................................67154 601.2 (f) added....................................................60221 607 Heading revised................................................60221 607.1 Added........................................................60221 607.3 (b) amended; (k) and (l) added...............................60222 607.7 Revised......................................................60222 607.20 (c) amended.................................................60222 [[Page 60]] 607.21 Amended.....................................................60222 607.22 Revised.....................................................60222 607.25 Revised.....................................................60222 607.26 Amended.....................................................60222 607.30 (a) introductory text revised...............................60222 607.35 Revised.....................................................60223 607.37 Revised.....................................................60223 607.39 Revised.....................................................60223 607.40 (d) introductory text and (3) revised; (e) added..........................................................60223 607.65 (g) added...................................................60223 607.80 (Subpart E) Added...........................................60223 610.20--610.21 (Subpart C) Removed.................................26691 Regulation at 81 FR 26691 eff. date confirmed....................52329 610.50 Revised.....................................................26691 Regulation at 81 FR 26691 eff. date confirmed....................52329 610.53 Revised.....................................................26691 Regulation at 81 FR 26691 eff. date confirmed....................52329 660.2 (c) revised..................................................38924 660.20 (a) revised.................................................38925 660.28 Revised.....................................................38925 660.35 Revised.....................................................38926 660.45 Revised.....................................................38928 660.50 (a) revised.................................................38928 660.55 Revised.....................................................38928 701 Nomenclature change............................................49897 710 Nomenclature change............................................49897 720 Nomenclature change............................................49897 801 Authority citation revised.....................................38930 801.15 Heading and (c)(1) revised..................................38930 801.109 (b)(1) revised.............................................38930 807.85 (a) introductory text revised...............................70340 809.10 (a)(4) and (b)(5)(ii) amended; (g) added....................38931 812.3 (b) revised..................................................70340 862 Actions on petitions....................................68293, 68295 870.4510 Added.....................................................71371 870.5200 Revised...................................................33133 870.5210 Added.....................................................33134 874.4180 Added.....................................................73029 876.5011 Added.....................................................45231 878.4420 Added.....................................................42244 878.4815 Added.....................................................64763 882.1561 Added.....................................................67155 882.5700 Added.....................................................44772 884.4050 Added.....................................................40183 886.1342 Added.....................................................65280 886.1925 Added.....................................................34270 886.5838 Added.....................................................37500 890 Authority citation revised.....................................71612 890.3450 Added.....................................................71612 890.5525 (b) revised; (c) removed..................................48706 1100 Added.........................................................29102 1105 Added.........................................................52334 1140 Heading revised...............................................29102 1140.1 Revised.....................................................29102 1140.2 Revised.....................................................29102 1140.3 Revised.....................................................29102 1140.10 Revised....................................................29103 1140.14 Revised....................................................29103 1143 Added.........................................................29103 1150 Authority citation revised....................................28715 1150.3 Amended.....................................................28715 1150.5 (a) amended; (c) and (d) added..............................28715 1150.7 (a)(1) revised; (a)(2) added................................28716 1150.9 (a)(1) revised; (a)(2) added................................28716 1250 Nomenclature change...........................................49897 1271.1 (a) and (b)(2) amended......................................60223 1271.3 (mm) and (nn) added.........................................60223 1271.20 Amended....................................................60223 1271.22 Revised....................................................60223 1271.23 Added......................................................60224 1271.25 (a) introductory text, (2), (3) and (c)(4) revised; (a)(5), (6) and (d) added.............................60224 1271.26 Revised....................................................60224 1271.90 (b) redesignated as (c); new (b) added; heading, (a)(3) introductory text, (4), new (c) introductory text, (2) and (6) revised.....................40517 1271.370 (b)(4) amended............................................40518 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1301 Policy statement..............................................53846 1301.74 (g) revised; interim.......................................58839 1301.75 (e) revised; interim.......................................58839 1305.07 Introductory text and (a) revised; interim 58839 1305.17 (d) revised; interim.......................................58839 1308.11 (b)(3) through (55) redesignated as (b)(4) through (56); new (b)(3) added.................................22025 (d)(48), (49) and (50) added; (h)(1), (2) and (3) removed; (h)(4) through (25) redesignated as new (h)(1) through (22).....................................29145 [[Page 61]] (h)(26) and (27) added...........................................29496 (d)(51) through (54) added; (h)(4) through (7) removed; (h)(8) through (22), (26) and (27) redesignated as new (h)(4) through (18), (19) and (20).......................................................61133 (d)(55), (56) and (57) added; (h)(1), (2) and (3) removed; (h)(4) through (20) redesignated as new (h)(1) through (17).....................................66184 1308.12 (c)(29) added; interim.....................................58839 1308.15 (e)(1), (2) and (3) redesignated as (e)(2), (3) and (4); new (e)(1) added; interim 29491 Proposed Rules: 1....................................................28035, 43155, 75349 2...........................................................74364, 74368 11..........................................................27067, 28035 15.................................................................60299 16............................................28035, 57812, 58342, 75351 56.................................................................19066 58..........................................................58342, 75351 73..........................................................63728, 69740 101.........................................................27067, 66562 111................................................................28035 112................................................................75349 117...........................................30219, 57816, 58421, 75349 172................................................................38984 175..................................................31877, 37561, 52370 176...........................................25625, 31877, 37561, 52370 177...........................................31877, 37561, 42585, 52370 178..................................................31877, 37561, 52370 216................................................................71648 310................................................................42912 330................................................................19069 507..................................................30219, 58421, 75349 511................................................................57812 514................................................................74962 556................................................................74962 558................................................................57818 573................................................................67260 610................................................................26753 807................................................................71415 820................................................................24041 882.........................................................24386, 32258 895.........................................................24386, 32258 1005...............................................................43155 1100.................................................28778, 28780, 28781 1105...............................................................52371 1140.................................................28778, 28780, 28781 1143.................................................28778, 28780, 28781 1150...............................................................28783 1271.................................................23661, 23664, 43155 1300--1399 (Ch. II).........................................53688, 53767 1300...............................................................63576 1301...............................................................63576 1302...............................................................63576 1303...............................................................63576 1304...............................................................63576 1308...................................59929, 61636, 63576, 66224, 70652 1309...............................................................63576 1310...............................................................63576 1312...............................................................63576 1313...............................................................63576 1314...............................................................63576 1315...............................................................63576 1316...............................................................63576 1321...............................................................63576