[List of CFR Sections Affected (LSA), January 2018] [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 Policy statement................17-16733, 17-30730, 17-51345, 17-55503 Policy statement................................................18-598 4.82 (b) revised................................................17-45393 10.60 (a), (d) and (f) revised..................................17-45393 10.61 Revised...................................................17-45394 11 Compliance notification; interim.............................17-20825 Technical correction; interim.................................17-34401 Policy statement................................................18-598 11.1 Regulation at 82 FR 20825 comment period extended to 8-2-17; interim.....................................................17-30730 12.5 Revised....................................................17-45394 12.11 (b) revised...............................................17-45394 14.100 (f) removed..............................................17-58554 16 Policy statement......................................18-598, 18-2057 16.1 (b)(2) amended.............................................17-61446 17.3 (a) revised................................................17-34402 18 Revised......................................................17-45394 19.15 (f) and (g)(1) revised....................................17-45404 21.112 Notification.............................................17-42031 73.70 Added.....................................................17-51557 Regulation at 82 FR 51557 eff. date confirmed..................18-4423 73.530 (c) revised..............................................17-30734 Regulation at 82 FR 30734 confirmed...........................17-43845 101 Compliance notification; interim............................17-20825 101 Technical correction; interim...............................17-34401 101.8 Regulation at 82 FR 20825 comment period extended to 8-2-17; interim.....................................................17-30730 101.9 Regulation at 82 FR 20825 comment period extended to 8-2-17; interim.....................................................17-30730 106 Policy statement..............................................18-598 110 Policy statement..............................................18-598 111 Policy statement..............................................18-598 112 Policy statement..............................................18-598 113.63 (c)(1) revised...........................................17-45404 114 Policy statement..............................................18-598 117 Policy statement............................................17-51345 Policy statement................................................18-598 120 Policy statement..............................................18-598 121 Notification................................................17-40484 122.92 (g) revised..............................................17-45405 122.118 (b) revised.............................................17-45405 122.119 (b) revised.............................................17-45405 122.120 (c) and (k) revised.....................................17-45405 123 Policy statement..............................................18-598 123.31 (b) revised..............................................17-45405 123.32 Revised..................................................17-45405 123.34 Removed..................................................17-45405 123.42 (c) heading, (1) and (d) introductory text revised.......17-45405 123.52 (a) revised..............................................17-45405 123.64 (a) revised..............................................17-45405 129 Policy statement..............................................18-598 133 Policy Statement............................................17-37815 141.61 (e)(1)(i)(A) revised.....................................17-45405 142.18 (a)(1) and (2) revised...................................17-45406 142.28 (a)(2) revised...........................................17-45406 143.1 (c) revised...............................................17-45406 [[Page 15]] 144.22 (b) revised..............................................17-45406 144.36 (c), (d) introductory text, (f) and (g)(4) revised.......17-45406 144.37 (a) and (b) revised......................................17-45406 146.62 (a) and (b)(2) revised...................................17-45407 146.66 (a) and (b) amended......................................17-45407 146.67 (b) and (c) revised......................................17-45407 146.68 Revised..................................................17-45407 151.9 Revised...................................................17-45407 177.1210 (b)(5) table 1 amended.................................17-20832 179 Policy statement..............................................18-598 181.47 (b)(2)(ii)(E) Amended....................................17-45407 201.128 Regulation at 82 FR 2217 comment period extended to 7-18- 17..........................................................17-22741 211 Policy statement..............................................18-598 310.545 (a)(27)(v), (vi), (vii), (viii), (ix), (x) and (d)(42) added; (d) introductory text amended........................17-60502 507 Policy statement............................................17-51345 Policy statement................................................18-598 510.600 (c)(1) table and (2) table correctly amended............17-21690 (c)(1) table and (2) table amended............................17-43484 (c)(1) table and (2) table amended............................17-58555 511.1 Heading and (c)(6) revised; (c)(1) and (2) amended; (c)(1)(i), (ii), (2)(i) and (ii) added......................17-61446 520.48 (b) correctly amended....................................17-21690 520.88g (c)(1)(ii) and (2)(ii) amended..........................17-43484 Heading, (a), and (b) revised.................................17-58556 520.304 (b)(1) and (2) revised; (b)(3) removed..................17-43484 520.980 (b) correctly amended...................................17-21690 520.1445 (c)(1)(ii) revised.....................................17-58556 520.1454 (b) correctly amended..................................17-21690 522 Drug application approvals withdrawn........................17-21694 522.90b (a) correctly amended...................................17-21690 522.304 (b) revised.............................................17-43484 522.970 (b)(1) revised; (b)(3), (e)(2)(ii)(B) and (iii) removed; (e)(2)(ii) amended..........................................17-43484 522.1002 (b) correctly removed; (c) correctly redesignated as new (b).........................................................17-21690 522.1002 (b)(1) revised.........................................17-43484 522.1055 (b) correctly amended..................................17-21690 522.1335 (b) amended............................................17-58556 522.1362 (b) correctly amended..................................17-21690 522.1450 (b) correctly amended..................................17-21690 522.1660a (e)(1)(ii) amended....................................17-43484 522.1662a (e)(1) correctly revised; (e)(3)(i)(c) correctly amended 17-21690 522.2470 (b), (c)(1)(i), (ii), and (2) revised..................17-58556 522.2473 (b) correctly amended..................................17-21691 522.2477 (b)(2) correctly revised; (d)(4) correctly added.......17-21691 (b)(2) revised; (d)(1)(iii) through (4)(iii) amended; (d)(5) added.........................................................17-43484 524.998 (c)(2) added............................................17-43485 524.1450 (b)(1) correctly amended...............................17-21691 524.1580a (d)(3) amended........................................17-58556 529.1030 (d)(1)(ii), (2)(iii), and (3) revised; (d)(2)(i) table and (ii) table amended......................................17-58556 558.4 (d) table correctly amended...............................17-21691 (d) table revised.............................................17-43485 558.58 (f)(4) and (5) removed...................................17-58557 558.76 (e)(1)(vii) correctly removed............................17-21691 558.115 (d)(4) correctly revised................................17-21691 558.128 (b)(1), (e)(1)(i), (v), (3)(v), (4)(iii) correctly amended; (e)(4)(xxiv) and (xxv) correctly redesignated as (e)(4)(xxv) and (xxvi); new (e)(4)(xxiv) correctly added....17-21691 (e)(4)(iii), (xi), (xii), (xiii), (5)(ii), (iii) and (6)(v) amended.......................................................17-43485 558.140 (b)(1) correctly amended................................17-21691 558.325 (e)(2)(vii) and (viii) correctly redesignated as (xvi) and (xvii); new (e)(2)(vii) correctly added.....................17-21691 558.366 (e) correctly revised...................................17-21692 (e) removed...................................................17-58557 558.485 (e)(1)(iv) correctly removed............................17-21692 558.550 (d)(5) correctly added..................................17-21692 558.625 (d)(2) correctly revised; (d)(4) and (5) correctly added; (e)(2)(iv), (v), (vi), (vii), (viii), (ix), (x), (xi), (xii), (xiii), (xiv) and (xv) corectly amended.....................17-21692 (e)(1)(vii), (ix), (2)(ii), (iii), (vi) through (xv) amended 17-43485 558.635 (e)(1) correctly revised................................17-21692 558.680 (e) correctly removed; (d)(3) correctly added...........17-21693 [[Page 16]] 573.170 (c) and (d) redesignated as (d) and (e); new (c) and new (d)(3) added; new (e) introductory text revised.............17-52209 573.480 (b)(3) and (4) redesignated as (b)(4) and (5); new (b)(3) and (b)(4)(iii) added; new (b)(5) introductory text revised 17-52209 (b) introductory text and (5)(iii)(B) revised....................18-20 573.492 Added...................................................17-38596 600.21 Amended; eff. 6-11-18.....................................18-3589 600.22 Removed; eff. 6-11-18.....................................18-3589 801 Policy statement.............................................18-2057 801.4 Regulation at 82 FR 2217 comment period extended to 7-18-17 17-22741 803 Policy statement.............................................18-2057 806 Policy statement.............................................18-2057 810 Policy statement.............................................18-2057 814 Policy statement.............................................18-2057 814.3 (n) amended...............................................17-26349 814.100 (b) introductoty text amended...........................17-26349 814.102 (a)(5), (b)(3)(i) and (ii) amended......................17-26349 814.124 (a) revised.............................................17-26349 814.126 (b)(1)(iii) amended.....................................17-26349 820 Policy statement.............................................18-2057 821 Policy statement.............................................18-2057 822 Policy statement.............................................18-2057 830 Policy statement.............................................18-2057 860.123 (b)(1) revised..........................................17-39535 862.1220 Added..................................................17-50072 862.1840 Added..................................................17-51559 862.3652 Added..................................................17-48415 862.3800 Added..................................................17-61163 864 Authority citation revised.....................................18-22 864.1865 Added....................................................18-234 864.3700 Added.....................................................18-22 864.7010 Added..................................................17-61165 866 Authority citation revised..................................17-34850 866.2190 Added..................................................17-47969 866.2680 Added..................................................17-50074 866.3215 Added..................................................17-49099 866.3361 Added..................................................17-49101 866.3920 Added..................................................17-34850 866.3970 Added..................................................17-48763 866.4750 Added..................................................17-52648 876.5550 Added..................................................17-52651 866.5665 Added..................................................17-50076 866.5670 Added..................................................17-49103 866.5930 Added..................................................17-50079 866.5940 (b) introductory text revised..........................17-51570 866.5950 Added..................................................17-51561 866.5985 Added..................................................17-47971 866.6060 Added..................................................17-50532 868 Authority citation revised..................................17-60867 868.5105 Added..................................................17-60867 870 Technical correction........................................17-46900 870.1251 Added...................................................18-4140 870.1255 Added..................................................17-34852 870.2200 Added..................................................17-35067 876 Technical correction........................................17-50080 876.4340 Added..................................................17-45727 876.5981 Added..................................................17-35069 878.4371 Added.....................................................18-24 878.5050 Added...................................................18-4143 880 Authority citation revised..................................17-60307 880.2750 Added..................................................17-60307 882 Technical correction........................................17-47373 882.1580 Added..................................................17-50082 882.1630 Added..................................................17-35071 882.5801 Added..................................................17-61167 882.5892 Added..................................................17-61169 884 Authority citation revised..................................17-35073 884.1710 Added..................................................17-35073 884.4350 Added..................................................17-60114 884.5210 Added..................................................17-61448 886 Authority citation revised..................................17-60115 886.5300 Added..................................................17-60116 892.5720 Added..................................................17-61171 892.5725 Added....................................................18-601 1100.5 Regulation at 82 FR 2217 comment period extended to 7-18-17 17-22741 1271 Policy statement.................................17-54289, 17-54290 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1301 Authority citation revised..................................18-3074 1301.28 (b)(1)(i), (ii) and (iii) revised........................18-3074 1308 Policy statement............................................18-4411 1308.11 (h)(10) through (15) added (temporary)..................17-17123 (h)(16) added (temporary).....................................17-20547 (h)(4) removed; (b)(3) through (56) and (h)(5) through (15) redesignated to (b)(4) through (57) and (h)(4) through (14); new (b)(3) and new (15) added.....................................17-26351 (h)(17) added (temporary).....................................17-32457 (d)(69), (70) and (71) added; (h)(1), (2) and (3) removed; [[Page 17]] (h)(4) through (17) redesignated as (h)(1) through (14).......17-47974 (h)(15) through (21) added (temporary)........................17-49508 (h)(18) added (temporary).....................................17-51158 (b)(40) through (57) redesignated as (b)(41) through (58); new (b)(40) added.................................................17-58559 (h)(22) added (temporary).......................................18-472 1308.12 (b)(1) introductory text revised........................17-45438 Regulation at 82 FR 14820 confirmed...........................17-55506 1310.02 (a)(1) through (30) redesignated as (a)(2) through (31); new (a)(1) added............................................17-32460 1310.04 (g)(1)(i) through (x) redesignated as (g)(1)(ii) through (xi); new (g)(1)(i) added...................................17-32460 1310.09 (n) added...............................................17-32460 1310.12 (c) table amended.......................................17-32460 Proposed Rules: 1--1299 (Ch. I)........17-40278, 17-40312, 17-42492, 17-42494, 17-42497, 17-42499, 17-42501, 17-42503, 17-42506, 17-43720, 17-49300, 17- 57560 1.....................................18-3442, 18-3443, 18-3445, 18-3447 5f..............................................................17-43720 7................................................................18-2758 10...............................................................18-2388 11....................................................17-28277, 17-52036 15....................................................17-56759, 17-58572 ...............................................................18-2952 46..............................................................17-43720 73....................................................17-16321, 17-52037 74..............................................................17-24912 101.........................................17-45753, 17-50324, 17-52036 ...............................................................18-2393 112...................................................17-42963, 17-47656 ...............................................................18-3447 117.............................................................17-41364 ......................................................18-3447, 18-3449 170...................................................17-20847, 17-53433 172.............................................................17-34615 172.............................................................17-39711 177.............................................................17-20847 189.............................................................17-20847 201..............................................................18-2092 312.............................................................17-28277 507..............................................................18-3447 570.............................................................17-53433 573..........17-18268, 17-24611, 17-34615, 17-43197, 17-44128, 17-44129, 17-44368, 17-44542, 17-50598, 17-60920, 17-60921 600..............................................................18-3631 800..............................................................18-2388 801..............................................................18-2092 803.............................................................17-60922 812.............................................................17-28277 878.............................................................17-56763 880.............................................................17-51585 884.............................................................17-57174 1100.............................................................18-2092 1300--1399 (Ch. II).............................................17-29248 1308.........17-25564, 17-32153, 17-42624, 17-42754, 17-55333, 17-58575, 17-61700 ...............................................................18-4406