[List of CFR Sections Affected (LSA), January 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 Technical correction.............................................22403 Compliance date clarification....................................71934 Authority citation revised................................74340, 74650 1.94 Revised.......................................................55242 1.101 (d)(2)(i) amended............................................18090 1.227 Revised......................................................56141 Amended...........................................................3715 1.241 (a) revised..................................................56143 1.276 (b)(9) revised...............................................56143 1.328 Amended......................................................56143 Amended...........................................................3715 1.363 Revised......................................................56144 1.500--1.514 (Subpart L) Added.....................................74340 1.600--1.695 (Subpart M) Added.....................................74650 11 Compliance date clarification...................................71934 11.1 Regulation at 79 FR 71253 and 71291 compliance date extended 39675 (i) added........................................................56144 (j) added........................................................56336 (l) added........................................................74352 (k) added........................................................74547 (m) added........................................................74667 14.100 (c)(2) introductory text revised............................18307 16 Technical correction............................................22403 Authority citation revised.......................................42723 Compliance date clarification....................................71934 16.1 (b)(2) amended.........................................56144, 56336 (b)(1) and (2) amended...........................................74547 (b)(2) amended...................................................74667 20.100 (c)(45) added...............................................38938 25 Technical correction............................................70679 25.15 (a), (c) and (d) amended.....................................57535 25.20 Introductory text revised; (o) and (p) added.................57535 25.30 Introductory text amended....................................57535 25.35 Added........................................................57535 25.40 (a) amended..................................................57535 25.50 (b) amended..................................................57535 25.52 (a) amended; (b) and (c) revised.............................57535 26.1--26.21 (Subpart A) Appendix E amended.........................18090 73.200 Regulation at 80 FR 14842 eff. date confirmed...............31466 73.350 (c)(1)(ii) revised; (c)(1)(iii) added.......................32307 Regulation at 80 FR 32307 confirmed..............................46190 (c)(1)(ii)(A) revised............................................58602 Regulation at 80 FR 58602 eff. date confirmed....................76859 73.530 (c) revised.................................................50765 Regulation at 80 FR 50765 eff. date confirmed....................66415 73.1530 Added......................................................50765 Regulation at 80 FR 50765 eff. date confirmed....................66415 91.5 Amended.......................................................75804 99.201 (c)(1) amended..............................................18090 101.8 Regulation at 79 FR 71291 compliance date extended...........39675 101.9 Regulation at 79 FR 71253 and 71291 compliance date extended 39675 101.10 Regulation at 79 FR 71253 compliance date extended..........39675 101.11 Regulation at 79 FR 71253 compliance date extended..........39675 106 Compliance date clarification..................................71934 106.100 (n) revised................................................56144 107.10 (a)(2) revised..............................................35840 Regulation at 80 FR 35840 eff. date confirmed; eff. 6-22-16......61293 107.100 (a) revised................................................35841 Regulation at 80 FR 35841 eff. date confirmed; eff. 6-22-16......61293 110 Removed; eff. 9-17-18..........................................56144 Compliance date clarification....................................71934 111.5 Amended......................................................74352 112 Added..........................................................74547 Policy statement.................................................74670 114 Compliance date clarification..................................71934 114.5 Revised......................................................56144 117 Added..........................................................56145 Policy statement.................................................56358 Compliance date clarification....................................71934 117.1 (b) revised...................................................3715 117.3 Eff. date pending in part....................................56145 Amended...........................................................3715 117.5 Eff. date pending in part....................................56145 Regulation at 80 FR 56145 eff. date confirmed in part............74354 (a) amended; (h)(3)(v) revised....................................3716 [[Page 19]] 117.8 Eff. date pending in part....................................56145 Regulation at 80 FR 56145 eff. date confirmed in part............74354 Correctly revised.................................................3956 117.95 Added.......................................................56337 117.136 (a)(2) introductory text, (5) and (b)(5) revised.........................................................3716 117.145 (a) revised.................................................3716 117.201 (b)(2)(i)(B) and (ii) revised...............................3716 117.257 (e) revised.................................................3716 117.264 (a)(1) revised..............................................3716 117.405 Eff. date pending in part..................................56145 Regulation at 80 FR 56145 eff. date confirmed in part............74354 (c) introductory text corrected...................................3956 117.410 Eff. date pending in part..................................56145 Regulation at 80 FR 56145 eff. date confirmed in part............74354 117.430 Eff. date pending in part..................................56145 Regulation at 80 FR 56145 eff. date confirmed in part............74354 117.435 Eff. date pending in part..................................56145 117.475 Eff. date pending in part..................................56145 Regulation at 80 FR 56145 eff. date confirmed in part............74354 120 Compliance date clarification..................................71934 120.3 Introductory text amended....................................56167 120.5 Revised......................................................56167 120.6 (b) amended..................................................56167 123 Compliance date clarification..................................71934 123.3 Introductory text amended....................................56167 123.5 (a) revised..................................................56167 123.11 (b) introductory text revised...............................56167 129 Compliance date clarification..................................71934 129.1 Revised......................................................56167 150.141 Removed....................................................72585 150.161 Removed....................................................72585 161.170 (a)(5)(ii)(b) removed; (a)(5)(ii)(a) redesignated as (a)(5)(ii).....................................................41436 172.185 (a) revised; (b) and (c) redesignated as (c) and (d); new (b) added......................................................34276 176.170 (a)(5) table amended...........................................8 179 Compliance date clarification..................................71934 179.25 (a) revised.................................................56168 201.25 (d)(2) amended..............................................18090 201.58 Amended.....................................................18090 203.12 Revised.....................................................18090 203.37 (e) revised.................................................18090 203.70 (b)(2) revised..............................................18091 206.7 (b)(1)(i) amended............................................18091 207.7 (a) amended..................................................18091 211 Compliance date clarification..................................71934 211.1 (c) amended..................................................56168 310 Authority citation revised.....................................38938 310.305 Regulation at 79 FR 33087 eff. date delayed................30151 310.306 Added......................................................38938 310.503 (f)(3) amended.............................................18091 312.140 (a)(3) amended.............................................18091 312.145 (b) amended................................................18091 312.310 (d)(1) amended.............................................18091 314 Regulation at 79 FR 33088 eff. date delayed....................30151 Authority citation revised.......................................38938 314.80 Regulation at 79 FR 33088 eff. date delayed.................30151 314.81 (b)(3)(iii) revised.........................................38938 314.91 Removed.....................................................38939 314.98 Regulation at 79 FR 33089 eff. date delayed.................30151 314.440 (b) introductory text revised..............................18091 317 Order..........................................................50559 329 Regulation at 79 FR 33089 eff. date delayed....................30151 500.23 Revised.....................................................56337 507 Added..........................................................56337 Policy statement.................................................56360 507.3 Eff. date pending in part....................................56337 Amended...........................................................3717 507.5 (e)(5) revised................................................3717 507.7 (b)(2)(i)(B) and (ii) revised.................................3717 507.12 Eff. date pending in part...................................56337 Regulation at 80 FR 56145 eff. date confirmed in part............74354 507.19 (b)(2) revised...............................................3717 507.27 (b) revised..................................................3717 507.33 (c)(1) revised...............................................3717 507.36 (a)(2) introductory text, (3) introductory text, (5) and (b)(5) revised....................................3717 507.47 (b)(1)(i)(A) and (B)(1) revised..............................3718 [[Page 20]] 507.50 (c)(1) revised...............................................3718 507.51 (a)(4)(iii) revised..........................................3718 507.65 (e) revised..................................................3718 507.69 (a)(1) revised...............................................3718 507.105 Eff. date pending in part..................................56337 Regulation at 80 FR 56145 eff. date confirmed in part............74354 507.110 Eff. date pending in part..................................56337 Regulation at 80 FR 56145 eff. date confirmed in part............74354 507.130 Eff. date pending in part..................................56337 Regulation at 80 FR 56145 eff. date confirmed in part............74354 507.135 Eff. date pending in part..................................56337 507.175 Eff. date pending in part..................................56337 Regulation at 80 FR 56145 eff. date confirmed in part............74354 510.600 (c)(1) table and (2) table amended...18775, 34278, 61295, 73104, 76386 (c)(1) table and (2) table amended................................3324 514 Authority citation revised.....................................31733 514.1 (b)(9) revised...............................................31733 516.1318 Removed....................................................3324 520 Drug application approvals withdrawn...........................76387 520.43 (c)(2) revised..............................................18775 520.48 (b) revised.................................................34278 520.88g (c)(2)(i) amended..........................................34278 520.154a Heading revised; (d)(1)(ii), (2)(i)(A), (ii)(A), (3)(ii) and (4)(ii) amended............................................34278 520.304 (b)(3) amended.............................................34278 (b)(2) amended...................................................61296 520.441 (b)(4) amended.............................................18775 520.446 (b)(1) amended.............................................76386 520.804 (c)(i), (ii) and (iii) redesignated as (c)(1), (2) and (3) 34278 520.905a (a) and (e)(4)(i) revised; (e)(4)(iii) amended; (e)(5) added..........................................................76386 520.1156 Added.....................................................18775 520.1315 (c)(1) revised............................................53459 520.1367 (b)(2) amended............................................53459 520.1443 (b) amended...............................................18776 520.1447 (b) amended...............................................18776 520.1510 Heading and (b) revised; (d)(1)(ii)(B) amended............18776 520.1660d (a)(4) revised...........................................34278 520.1855 (b) amended...............................................34278 (c)(1) revised...................................................53459 520.2043 (b)(2) amended............................................76386 520.2158 (b) amended...............................................18776 (d)(1) and (2) revised; (d)(3) added.............................61296 520.2218 (d)(1)(i)(A), (B), (2)(i)(A) and (B) revised..............34278 520.2261b (d)(4)(iii) amended......................................61296 520.2598 (a) amended...............................................53460 520.2640 (e)(2)(iii) and (3)(iii) amended..........................34278 522 Drug application approval withdrawn............................18777 522.167 Added......................................................18776 522.230 (b) amended................................................18776 522.690 (d)(1) and (2) redesignated as (d)(2) and (4); new (d)(1) added; new (d)(2)(ii) and (3)(ii) amended; (a), (b), (c) and new (d)(4) introductory text revised...........................61296 (b)(2) and (d)(1)(i) revised; (b)(3) added.......................76386 522.812 (b)(3) added...............................................18776 (b)(2) revised...................................................61296 522.955 (a), (b), (d)(1) heading, (i) introductory text, (C), (ii) introductory text and (C) revised..............................61296 (b)(2) amended...................................................76386 522.1004 Removed...................................................18776 522.1073 Removed...................................................34278 522.1075 Removed...................................................34278 522.1077 Revised...................................................34279 522.1145 (e)(2)(i) amended.........................................34279 522.1289 (a) amended...............................................61297 522.2005 (b)(2) revised; (b)(3) removed............................18776 522.2075 Added.....................................................61297 522.2470 (b) revised...............................................34279 522.2483 (b) revised...............................................34279 524.154 (a)(1), (2) and (b)(2) revised.............................61297 524.957 Added......................................................76387 524.1044a Revised..................................................18776 524.1450 (a), (b) and (d) revised; (e) removed.....................53460 524.1484g (a) and (b) revised......................................61297 526.313 (d)(1)(ii) revised.........................................34279 528.1070 (b) amended...............................................34279 528.1092 Added.....................................................73104 529.1186 (b) amended...............................................18776 529.1350 (b) amended...............................................18776 529.2150 (b) amended...............................................18776 556.60 Removed.....................................................78970 556.68 Added.......................................................61297 [[Page 21]] 558 Authority citation revised.....................................31733 Policy statement.................................................58602 Drug application approvals withdrawn...............61298, 76387, 78970 558.3 (b)(1)(ii), (6), (7), (9) and (11) revised; (b)(12) added....31733 558.4 (d) table amended.....................................61297, 78970 558.6 Revised......................................................31733 (b)(5) and (c) introductory text corrected.......................35841 558.68 Added.......................................................61297 (c)(1) revised...................................................76387 558.76 (d)(3)(xiii) removed........................................78970 (b), (c) and (d) redesignated as (c), (d) and (e); new (b) added; heading, (a) and new (e)(1) revised.......................79474 558.95 (d)(4)(ii) table amended....................................53460 558.128 (b)(2), (e)(1) table, (2) table, (3) table, (iv) and (4) table amended..................................................18776 558.261 (c)(1) and (2) revised.....................................76387 558.369 Removed....................................................78970 558.460 (a) and (b) revised........................................61298 558.500 (e)(1)(ii), (iii), (iv), (2)(iv), (ix), (x) and (xiii) amended........................................................61298 558.618 (e)(2)(i) amended..........................................61298 (c)(1) revised...................................................76387 558.625 (b)(5) removed; (b)(6) redesignated as new (b)(5)..........76387 558.630 (b)(2) amended.............................................76387 558.665 (e)(9) added...............................................18776 (d)(2) and (e) revised...........................................53460 573.490 Added......................................................35569 578.3 Amended......................................................75804 578.87 (b)(4) amended..............................................75804 578.103 (a)(4) through (17) redesignated as (a)(5) through (18); new (a)(4) added...............................................75804 579.12 Amended.....................................................56356 600 Regulation at 79 FR 33090 eff. date delayed....................30151 Authority citation revised.......................................38939 600.2 (a), (c)(1) and (2) amended..................................18091 Regulation at 79 FR 33090 eff. date delayed......................30151 600.11 (f)(6) amended..............................................18092 600.14 (e)(1) revised..............................................18092 600.22 (e) amended.................................................18092 600.80 Regulation at 79 FR 33090 eff. date delayed.................30151 600.81 Regulation at 79 FR 33091 eff. date delayed.................30151 600.82 Added.......................................................38939 600.90 Regulation at 79 FR 33092 eff. date delayed.................30151 601.2 (a) amended..................................................18092 (c)(1) amended...................................................37974 601.12 (f)(4) amended..............................................18092 601.15 Amended.....................................................18092 601.22 Amended.....................................................37974 601.28 Introductory text amended...................................18092 601.29 (b) amended.................................................18092 601.70 (d) amended.................................................18092 606.3 (a) and (c) revised..........................................29894 606.40 (a)(1) amended..............................................29895 606.100 (b) introductory text and (20) revised; (b)(1) amended; (b)(21) and (22) added.........................................29895 (b)(19) introductory text amended................................80651 606.110 (a) and (b) amended........................................29895 606.121 (c)(11), (12), (h)(2), (3) and (i)(5) amended..............29895 606.122 (e) amended................................................29895 606.145 Added......................................................29895 606.160 (b)(1)(ix), (x), (xi) and (e) revised......................29895 (b)(1)(viii) amended.............................................80651 606.170 (b) amended................................................18092 601.171 (e) revised................................................18092 607.7 (b) and (c) amended..........................................18092 607.22 (a) amended.................................................18092 607.37 Revised.....................................................18092 610.2 (a) and (b) amended..........................................18093 610.11 (g)(2) amended..............................................18093 Removed..........................................................37974 610.11a Removed....................................................37974 610.15 (a)(3) amended..............................................18093 610.39--610.48 (Subpart E) Heading revised.........................29896 610.39 Added.......................................................29896 610.40 (a), (b), (c) heading, (e) revised; (c)(2) and (i) removed; (c)(3) and (4) redesignated as new (c)(2) and (3); new (c)(2)(i), (d), (f), (g) introductory text, (h)(1), (2)(ii) introductory text, (C), (iv) introductory text, (A), (vi) and (vii) amended..................................................29896 610.41 (a) introductory text, (2) through (5) and (b) amended; (a)(1) revised.................................................29897 610.42 (a) amended.................................................29897 610.44 (a)(1) and (2) amended......................................29897 610.46 (a)(2), (3), (4), (b)(2) and (3) amended....................29897 [[Page 22]] 610.47 (a)(2), (3), (4), (b)(2) and (3) amended....................29897 610.48 Removed.....................................................80651 630 Heading revised................................................29898 630.1--630.3 (Subpart A) Added.....................................29898 630.5--630.35 (Subpart B) Added....................................29898 630.40 (Subpart C) Subpart and heading added.......................29898 630.6 Redesignated as 630.40.......................................29898 630.40 Redesignated from 630.10; Heading revised; (a), (b) introductory text, (1), (3), (c), (d)(1) introductory text, (i) and (iii) amended..........................................29898 640.3 Removed......................................................29904 640.4 (a) removed; (e) amended.....................................29904 640.5 Introductory text and (f) amended; (a) removed...............29904 640.12 Revised.....................................................29904 640.14 Amended.....................................................29904 640.21 Revised.....................................................29904 640.22 (c) revised.................................................29904 640.23 (a) amended.................................................29904 640.27 Removed.....................................................29904 640.31 Revised.....................................................29904 640.32 (b) amended.................................................29905 640.33 (a) amended.................................................29905 640.51 Revised.....................................................29905 640.52 (b) amended.................................................29905 640.53 (a) amended.................................................29905 640.61 Removed.....................................................29905 640.62 Removed.....................................................29905 640.63 Removed.....................................................29905 640.64 (a) removed.................................................29905 640.65 (b)(1)(i), (ii), (2)(iii) and (iv) amended; (b)(2)(i) revised........................................................29905 640.66 Amended.....................................................29905 640.67 Amended.....................................................29905 640.69 (e) and (f) added...........................................29905 640.71 (a) introductory text and (b)(1) amended; (a)(1) through (4) removed....................................................29905 640.72 (a)(2), (3) and (4) revised.................................29905 640.120 Revised....................................................29906 640.125--640.130 (Subpart M) Added.................................29906 660.3 Amended......................................................18093 660.6 (a)(2) and (c) heading amended...............................18093 660.22 (b) amended.................................................18093 660.31 Revised.....................................................29906 660.36 (a) introductory text, (b) and (c) amended..................18093 660.46 (a)(2) introductory text amended............................18093 660.52 Amended.....................................................18093 680.1 (b)(2)(iii), (3)(iv) and (c) amended.........................18093 680.3 (b) removed..................................................37974 801.55 (b)(1) amended..............................................18093 807.90 (a)(2) amended..............................................18094 812.19 (a)(2) amended..............................................18094 814.20 (h)(2) amended..............................................18094 814.104 (d)(2) amended.............................................18094 820.1 (a)(1) amended...............................................29906 822.8 Amended......................................................18094 866.3130 Added.....................................................51939 866.3365 Added.....................................................30154 866.3860 Added.....................................................46192 866.3990 Added.....................................................67314 866.5940 Added.....................................................65630 870.1415 Added.....................................................63673 870.4360 Revised...................................................32311 870.5700 Added.....................................................58606 870.5910 Added.....................................................49896 872.5560 Added.....................................................72586 874.3315 Added......................................................3324 874.5900 Added.....................................................46194 876.2050 Added.....................................................72900 876.5025 Added.....................................................30355 Republished......................................................35843 876.5140 Added.....................................................18309 876.5930 Added.....................................................30933 878.4670 Added.....................................................46486 880.6600 Added.....................................................72588 882.1470 Added.....................................................49138 884.5980 Added.......................................................361 (c) added..........................................................369 884.6165 Added.......................................................379 886.5905 Added.....................................................57092 890.3110 (b) revised...............................................72590 890.3480 Revised (republished).....................................25229 890.5290 (a)(1) and (b) revised; (c) removed.......................61302 895.30 (c) revised.................................................31300 1020.32 (b)(4)(ii)(A) revised......................................19532 Regulation at 80 FR 19532 eff. date confirmed....................43320 1271.22 (b)(1), (3), (c)(1) and (2) amended........................18094 1271.37 Revised....................................................18094 1271.350 (a)(5) amended; (b)(3) revised............................18095 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1308 Policy statement.......................................27854, 70658 Technical correction......................................70680, 78657 [[Page 23]] 1308.11 (h)(24) added..............................................42385 1308.12 (b)(4) revised.............................................54718 1308.14 (g)(3) added...............................................69864 1308.22 Table amended; interim..............................65634, 65637 1314.101 Regulation at 76 FR 20523 confirmed........................3959 1314.102 Regulation at 76 FR 20523 confirmed........................3959 1314.103 Regulation at 76 FR 20524 confirmed........................3959 Chapter III_Office of National Drug Control Policy (Parts 1400_1499) 1403 Regulation at 79 FR 76106 confirmed...........................57383 1404 Regulation at 79 FR 76106 confirmed...........................57383 1405 Regulation at 79 FR 76106 confirmed...........................57383 Proposed Rules: 1.............................................19160, 43987, 55802, 57136 2..................................................................36937 11..........................................................55564, 57136 15..........................................................32868, 54256 16.................................................................57136 73.................................................................22449 101........44302, 44303, 45465, 54446, 55564, 63477, 69905, 71990, 80718 ..................................................................3751 106................................................................57136 108................................................................57137 110................................................................57136 114................................................................57136 117................................................................57136 120................................................................57136 123................................................................57136 129................................................................57136 172................................................................65978 ....................................................................42 179................................................................57136 201.........................................................57756, 74737 211................................................................57136 225................................................................57136 299................................................................52224 300................................................................79776 310................................................................25166 314................................................................22953 320................................................................22953 330................................................................79776 500................................................................57136 507................................................................57136 514................................................................28863 558................................................................31520 573..................................................42069, 48471, 73153 579................................................................57136 601................................................................38145 610................................................................79776 801.........................................................57756, 74737 866................................................................71756 878................................................................79493 880................................................................60809 882................................................................81223 ..................................................................3751 1002...............................................................79505 1020...............................................................19589 1040...............................................................79505 1100..........................................37555, 51146, 57756, 74737 1140........................................................37555, 51146 1143........................................................37555, 51146 1271............................66844, 66845, 66847, 66849, 66850, 81233 1308............................27611, 29227, 31521, 48044, 55565, 70650