[List of CFR Sections Affected (LSA), December 2022] [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 Notification..............................................14169, 63686 1 Authority citation revised.......................................71077 1.71 Amended.......................................................62984 1.72 Introductory text revised.....................................62984 1.75 Revised.......................................................62984 [[Page 59]] 1.1101--1.1200 (Subpart R) Correction: Amended......................5660 1.1131 Correction: (a)(2) amended...................................5660 1.1300--1.1465 (Subpart S) Added...................................71077 4 Notification.....................................................16391 6 Regulation at 86 FR 5751 eff. date further delayed to 9-22-22.............................................12399 6 Regulation at 86 FR 5751 withdrawn...............................32246 7 Notification.....................................................12401 14.100 (c)(8) heading and (ii) revised.............................16394 20.20 Revised......................................................55911 20.22 (b)(3) added.................................................55911 20.26 Heading, (a) introductory text, (4), and (b) revised........................................................55911 20.33 (c) added....................................................55912 20.40 (a) revised..................................................55912 20.41 (b)(4) redesignated as (b)(5); new (b)(4) and (d) added; (b)(3)(i)(A) and new (5) revised........................................................55912 20.44 (e) revised..................................................55912 20.45 (a)(1) through (3), (c)(1), and (2) revised; (b)(7) added...................................................55912 20.49 (a) and (c) revised; (d) removed.............................55913 20.61 (e)(2) revised...............................................55913 20.62 Revised......................................................55913 20.82 (a) revised..................................................55913 20.85 Revised......................................................55913 20.86 Revised......................................................55913 20.88 (d)(1) introductory text, (i), (ii)(B), (C), (d)(2), (e)(1), and (3) revised................................55913 20.89 (d)(1) introductory text and (ii) revised....................55914 20.100 (c)(6) revised; (c)(20) and (21) removed; (c)(48) added..................................................55914 20.120 (a) revised.................................................55914 73.32 Added........................................................27935 73.32 Regulation at 87 FR 27935 eff. date confirmed......................................................54615 73.70 (b) and (c) revised; (f) added...............................58448 73.530 (c) revised.................................................67789 101.36 CFR correction: (e)(11)(viii) reinstated....................16983 101.100 (a)(4) revised; (j) added...................................2546 101 Appendix A removed..............................................2547 112 Notification...................................................14169 117 Notification...................................................14169 117 Regulation at 80 FR 56145 eff. date confirmed in part........................................................65527 118 Notification...................................................49521 121 Notification...................................................14169 130 Notification...................................................16394 130 Technical correction...........................................78857 130.9 (a) revised; (c) added........................................2547 130.10 (e) and (f) redesignated as (f) and (g); new (e) added..................................................76568 131 Notification...................................................16394 131 Technical correction...........................................78857 131.200 (a), (b), (c), (d)(2), and (8)(ii) stay lifted; (d)(2) and (8)(ii) revised; (g) and (h) redesignated as (h) and (i); new (g) added; new (i) introductory text amended.......................76568 165.110 (b)(4)(ii)(C) and (D) revised..............................23441 169.115 Removed.....................................................2042 170 Notification...................................................77983 170.30 CFR correction: (g) reinstated..............................17941 175.105 (c)(5) table amended.......................................31088 175.300 (b)(3)(viii)(b) amended....................................31089 175.320 (b)(3)(ii) amended.........................................31089 176.170 (b)(2) table amended.......................................31089 176.180 (b)(2) table amended.......................................31089 176.300 (d) amended................................................31089 177.1010 (a)(8) amended............................................31089 177.1200 (c) amended...............................................31089 177.1460 (b) amended...............................................31089 177.1590 (a) amended...............................................31089 177.2420 (b) amended...............................................31089 177.2600 (c)(4)(ii)(b) and (iv) amended............................31089 178.3740 (b) amended...............................................31089 178.3910 (a)(2) amended............................................31089 216 Notification...................................................63947 251 Notification...................................................31954 300 Authority citation revised.....................................56276 300.200 (Subpart D) Added..........................................56276 500.1410 Revised...................................................10966 507 Notification...................................................14169 507 Regulation at 80 FR 56337 eff. date confirmed in part........................................................65527 510.600 (c)(1) table and (2) table amended....10967, 17944, 58959, 76420 515.10 (a) revised.................................................58960 516.3 (b) amended..................................................56589 516.3 Regulation at 87 FR 56589 eff. date confirmed......................................................76425 516.498 Added......................................................17944 516.812 (b) amended................................................58960 516.1780 Added.....................................................76421 516.2065 Removed...................................................10968 [[Page 60]] 520.88g (b)(2), (c)(1)(ii), and (2)(ii) revised....................58960 520.88h Revised.............................................10968, 17944 520.314 (b) amended................................................76421 520.530 (c) removed; (d) redesignated as new (c) 58961 520.563 Heading revised............................................76421 520.812 (b)(1) and (3) revised.....................................58961 520.905a (e)(1)(ii) and (iii) revised..............................58961 520.905c (e)(1)(i) revised.........................................10968 520.928 Heading, (a), (b), and (c)(1)(i) revised 58961 520.1044c (d)(2) revised...........................................10968 520.1242a (b)(3) revised...........................................58961 520.1660d (d)(1)(iii)(A) and (C) revised...........................10968 520.1720a (a) revised..............................................58961 520.1780 (c)(2) revised............................................10968 520.1846 Removed...................................................58961 520.1870 (c)(2)(iii) amended.......................................58961 520.1872 (c)(1)(iii) revised.......................................58961 520.2090 (c)(2) revised............................................17945 520.2130 (a) revised...............................................10968 520.2220a (d)(1)(iii) and (2)(iii) revised.........................10968 520.2260a Revised..................................................58961 520.2260b (b) and (e) removed; (f)(2)(ii) amended 10969 520.2325a (c)(4)(iii) and (d) revised..............................58962 520.2330 (c)(3) amended............................................76421 520.2455 (b)(1) through (4) revised; (d)(2) amended........................................................17945 520.2455 (b)(3) revised............................................58962 520.2471 (b) revised...............................................58962 520.2598 (c)(2) revised............................................58962 520.2604 (c)(2) revised............................................10969 520.2640 (a), (b), (e)(2)(i), and (3)(i) revised 76421 522.246 (b)(2) and (3) revised.....................................17945 522.533 (b)(2) amended.............................................17945 522.533 (c)(1)(ii) and (2)(ii) revised.............................58962 522.558 (b)(1) amended.............................................10969 522.690 (a), (b), (d)(1) introductory text, (i), (2)(ii), and (3)(ii) revised; (d)(2) introductory text and (3) introductory text added; (d)(4) removed..........................................17945 522.812 (b)(1) revised.............................................10969 522.812 (b)(2) revised......................................17945, 58962 522.840 (d)(2) amended.............................................10969 522.842 Redesignated as 522.2343...................................10969 522.955 (b)(2) and (d)(1)(ii)(C) revised; (b)(3) redesignated as (b)(4); new (b)(3) and (d)(2) added; (d)(1)(ii)(A)(2) and (B)(2) amended.....................10969 522.955 (b)(3) and (d)(1)(ii)(C) amended...........................17945 522.955 (b)(3), (d)(1)(ii)(A)(2), (B)(2), and (C) revised........................................................76421 522.1008 Added.....................................................58962 522.1077 (d)(1)(iv) revised........................................17946 522.1156 (c)(1) revised............................................10969 522.1338 Added.....................................................58962 522.1338 (b) amended...............................................76421 522.1662a (e)(1) revised; (e)(3)(i)(D), (ii)(C), and (iii)(D) added; (e)(3)(iv) through (vii) removed........................................................76421 522.1940 (c)(1) heading, (iii), (2) heading, and (iii) revised..................................................17946 522.2065 Added.....................................................10969 522.2343 New section redesignated from 522.842 and heading revised................................................10969 522.2343 (c) introductory text and (3) revised.....................17946 522.2470 (b) introductory text revised.............................10969 522.2471 (e)(2)(iii) revised.......................................76421 522.2477 (b)(2) revised; (d)(1)(i)(G) removed; (d)(6) added...................................................10969 522.2478 (d)(3) redesignated as (d)(4); new (d)(3) added; new (d)(4) heading and (i)(C) revised 17946 522.2615 (d)(3)(iii) revised.......................................58962 522.2630 (b)(1) and (2) revised.............................17946, 58962 522.2662 (b)(3) revised............................................17946 522.2690 (b) amended...............................................76422 524.230 Added......................................................58962 524.770 (e)(1) and (3) revised.....................................10970 524.1001 Heading and (a) revised...................................58963 524.1146 (b)(2) and (3) revised....................................17946 524.1146 (b)(1) and (2) revised....................................58963 524.2098 (b) revised...............................................58963 528 Heading revised................................................76422 529.1004 Redesignated from 529.1030................................10970 529.1030 Redesignated as 529.1004..................................10970 529.1186 (b) revised...............................................58963 529.1940 (e)(1)(iii) revised.......................................10970 529.1940 (e)(1)(iii) amended.......................................17947 529.2110 (b) revised...............................................58963 [[Page 61]] 556.240 (b)(1) and (c) revised.....................................17947 556.370 (b) revised................................................17947 556.710 (c) revised................................................10970 558.4 (d) table amended............................................58963 558.59 (d) redesignated as (e); new (d) added......................10970 558.95 (e)(4)(i) and (ii) revised..................................76422 558.128 (e)(4)(iii) and (xli) revised..............................58963 558.128 (e)(4)(x), (xi), (xiii), (xxx), and (xxxi) revised........................................................76422 558.205 (d)(1) and (2) revised.....................................10970 558.254 (e) introductory text amended..............................10971 558.254 (e) revised................................................17947 558.258 (e)(1), (2)(i), and (3) through (5) revised; (e)(2) table amended..................................58964 558.261 (e)(2)(ii) revised.........................................10971 558.311 (e)(3)(ix) added...........................................10972 558.342 (e)(1)(ii) revised.........................................76423 558.355 (d)(8)(vi), (f)(1)(ii), (iv), and (vi) revised........................................................17947 558.450 (e)(5)(ii) revised; (e)(5)(iii) through (vii) redesignated as (e)(5)(iv) through (viii); new (e)(5)(iii) added..................................10972 558.450 (e)(4)(ii) through (v) redesignated as (e)(4)(iii) through (vi); new (e)(4)(ii) added; (e)(4)(i), new (iii), and new (vi) revised........................................................76423 558.455 (e)(1)(ii) through (iv) and (2)(ii) through (iv) redesignated as (e)(1)(i) through (iii) and (2)(i) through (iii); (e)(3) and (4) revised; (e)(5) added..........................................76423 558.500 (b), (e)(2)(i), (iii), and (vi) revised....................17947 558.555 (f) amended................................................17948 558.575 (e)(3)(iv) and (v) revised.................................76424 558.633 (d)(3) revised......................................10972, 17948 558.633 (d)(3) amended.............................................58968 558.635 (e)(1)(iv) revised.........................................10972 558.680 (d)(1)(iii), (iv), (vii), (viii), and (2) revised........................................................17948 570 Notification...................................................77983 573.485 Added......................................................47344 573.485 Introductory text and (c) revised..........................52682 573.637 Introductory text and (b) revised..........................21019 720.8 (e) and (g) revised..........................................55914 800 Notification...................................................50568 800 Authority citation revised.....................................50748 800.30 Added.......................................................50748 801 Guidance.......................................................43987 801 Notification...................................................50568 801 Authority citation revised.....................................50755 801.420 Removed....................................................50755 801.421 Removed....................................................50755 801.422 Added......................................................50755 808 Notification...................................................50568 808 Authority citation revised.....................................50761 808 Amended........................................................50761 808.1 (a) through (f) headings and (g) added.......................50761 808.3 Revised......................................................50762 808.53 Removed.....................................................50762 808.55 Revised.....................................................50762 808.57--808.101 Removed............................................50762 814.40 Amended......................................................2045 814.44 (d)(1), (2), (e)(2)(ii), and (f)(2) amended 2045 814.45 (d)(1) and (e)(3) amended....................................2045 814.116 (b) amended.................................................2045 814.118 (c)(3) amended..............................................2045 822.8 Revised......................................................17950 822.12 Amended.....................................................17950 822.21 Revised.....................................................17950 862.1355 Added......................................................9238 862.1356 Added.....................................................14172 866.1655 Added......................................................6417 866.3956 Added.....................................................29665 866.3957 Added.....................................................29667 866.3958 Added.....................................................66548 866.5960 Added.....................................................79252 870.1252 Added......................................................9241 870.1342 Added.....................................................26991 870.1345 Added.....................................................34778 870.1405 Added.....................................................79803 870.1420 Added.....................................................32990 870.2210 Added......................................................8191 870.2220 Added.....................................................79254 870.2345 Added......................................................2549 870.2790 Added......................................................6419 870.4150 Added.....................................................80039 874 Notification...................................................50568 874.3300 Revised...................................................50762 874.3302 Added.....................................................50762 874.3305 (a) amended; (b) revised..................................50762 874.3315 (a) revised...............................................50762 874.3325 (a) amended; (b)(5) revised; (b)(7) removed........................................................50762 874.3950 (a) amended...............................................50762 876.1310 Added.....................................................26993 876.5026 Added.....................................................34166 878.3510 Added......................................................6421 [[Page 62]] 878.4550 Added.....................................................24273 878.4961 Added.....................................................26995 880.5730 Added......................................................6424 880.6887 Added......................................................8194 882.1491 Added.....................................................80445 882.5975 Removed....................................................2049 886.1100 Added......................................................3205 886.5305 Added......................................................9243 888.3043 Added.....................................................11294 888.3044 Added.....................................................80041 1141 Regulation at 85 FR 15708 eff. date further delayed to 4-9-23..............................................11295 1141 Regulation at 85 FR 15708 eff. date further delayed to 10-6-23.............................................50765 1141 Regulation at 85 FR 15708 eff. date delayed to 7-8-23......................................................32990 1141 Regulation at 85 FR 15708 eff. date further delayed to 11-6-23.............................................72384 1270 Removed........................................................2049 1271 Notification..................................................65681 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1301 Technical correction..........................................73246 1301.13 (e)(2) and (3) revised.....................................21022 1301.14 (b) removed; (c) and (d) redesignated as new (b) and (c); (a) and new (b) revised.......................21022 1301.24 (b) amended................................................66955 1301.37 (d) revised................................................68044 1301.43 Heading and (c) through (e) revised; (f) added..........................................................68044 1308.11 (d)(89) through (93) added; (h)(37) through (41) removed...........................................20321 1308.11 (h)(50) through (56) added (temporary).....................21561 1308.11 (d)(94) through (99) redesignated as (h)(42) through (h)(47)........................................32999 1308.11 (d)(100) added.............................................34169 1308.11 (f)(1) through (f)(9) redesignated as (f)(2) through (f)(10); new (f)(1) added.......................68898 1308.11 (b)(92) added..............................................70721 1308.11 (f)(7) through (10) redesignated as (f)(8) through (11); new (f)(7) added.................................71250 1308.11 (f)(9) through (11) redesignated as (f)(10) through (12); new (f)(9) added.........................75473 1308.12 (b)(4)(i) and (ii) revised; (b)(4)(iii) added..........................................................70717 1308.14 (c)(16) through (58) redesignated as (c)(17) through (59); new (c)(16) added; interim........................................................20318 1308.14 Regulation at 86 FR 24492 confirmed........................37735 1308.14 Regulation at 87 FR 20317 confirmed........................59298 1308.14 (d) removed................................................78859 1308.15 (e)(4) through (6) redesignated as (e)(5) through (7); new (e)(4) added; interim.........................32996 1308.15 Regulation at 87 FR 32996 confirmed........................67548 1309 Technical correction..........................................73246 1309.12 Revised....................................................21022 1309.32 (a) through (c) revised....................................21023 1309.33 Revised....................................................21023 1309.34 (a) revised................................................21023 1309.46 (d) revised................................................68044 1309.53 Heading and (b) through (d) revised; (e) added..........................................................68045 1310.02 (a)(39) added..............................................67552 1310.04 (g)(1)(iii) through (xviii) redesignated as (g)(1)(iv) through (xix); (g)(1)(iii) added 67552 1310.12 (c) table amended..........................................67552 1316 Technical correction..........................................73246 1316.47 Revised....................................................68045 1316.49 Amended....................................................68045 1321.01 Table amended..............................................21023 Proposed Rules: 1....................................................25432, 55932, 60947 2..................................................................42398 4...........................................................10119, 31302 10...........................................................6708, 31439 12...........................................................6708, 31439 15...........................................................2093, 18750 16....................................................6708, 31302, 31439 50..........................................................58733, 68118 56...................................................58733, 58752, 68118 73..................................................................8222 80.................................................................66116 101.........................................................59168, 73267 112...........................................................913, 42973 170.................................................................3949 172................................................................26707 173................................................................70752 174.........................................................41079, 65020 175...........................................31066, 36426, 41079, 65020 176.........................................................31066, 36426 177...........................................31066, 36426, 41079, 65020 [[Page 63]] 178.........................................................31066, 36426 190................................................................30843 201...........................................31302, 38313, 44038, 64178 203...........................................................6443, 6449 205..........................................................6708, 31439 207................................................................44038 210................................................................31302 211................................................................31302 213................................................................31302 230................................................................31302 312.........................................................75536, 75551 314..................................................31302, 38313, 64178 514................................................................31302 516................................................................56604 573................................................................21069 630................................................................31440 640................................................................31440 812.........................................................58733, 68118 820................................................................10119 866.................................................................3250 878................................................................39025 1162.................................................26311, 26454, 36786 1166.................................................26311, 26396, 36786 1301...............................................................42662 1308...............2376, 21069, 21588, 40167, 42979, 45076, 52712, 78887 1310...............................................................57852