[List of CFR Sections Affected (LSA), February 2025] [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) Chapter I Policy statement.........................................84819 1 Notification.....................................................47463 [[Page 31]] 1.94 (a) and (c) revised...........................................47080 4 Authority citation revised.......................................51765 4.2 Revised; eff. 2-2-26...........................................51765 4.3 (a), (c), and (d) revised; (e) added; eff. 2-2-26..............51766 4.4 (b)(1) introductory text, (2) introductory text, and (e) revised; (b)(3) and (4) redesignated as (b)(4) and (5); new (b)(3) added; eff. 2-2-26......................................51766 14.100 (e) removed.................................................46802 14.100 (b)(1) removed; (b)(2) through (4) redesignated as new (b)(1) through 3...............................................56663 16 Technical correction............................................83781 16.1 (b)(2) revised; eff. 12-18-25.................................51766 16.1 (b)(1) revised................................................77023 16.1 (b)(2) Table 1 redesignated as (b)(2) Table 2; eff. 12-8-25 77023 16.1 Regulation at 89 FR 77023 withdrawn............................5590 73.297 Added........................................................5594 74.303 Removed......................................................4634 74.1303 Revised.....................................................4634 74.1303 Removed; eff. 1-18-28.......................................4634 80.10 (a) and (b) revised..........................................88641 101 Uniform compliance date.......................................106996 101.13 (b)(2)(ii) revised.........................................106162 101.13 Regulation at 89 FR 106162 eff. date delayed to 4-28-25.............................................10592 101.65 (a)(2) and (d) revised.....................................106162 101.65 Regulation at 89 FR 106162 eff. date delayed to 4-28-25.............................................10592 112 Notification...................................................77775 112.3 Amended......................................................37514 112.12 (a) revised.................................................37515 112.40--112.50 (Subpart E) Revised.................................37515 112.151 Heading and (b)(2) revised.................................37518 112.161 (b) revised................................................37519 161 Notification...................................................33229 164 Notification...................................................33229 175.105 Regulation at 87 FR 31088 confirmed........................86239 175.300 Regulation at 87 FR 31089 confirmed........................86239 175.320 Regulation at 87 FR 31089 confirmed........................86239 176.170 Regulation at 87 FR 31089 confirmed........................86239 176.180 Regulation at 87 FR 31089 confirmed........................86239 176.300 Regulation at 87 FR 31089 confirmed........................86239 177.1010 Regulation at 87 FR 31089 confirmed.......................86239 177.1200 Regulation at 87 FR 31089 confirmed.......................86239 177.1460 Regulation at 87 FR 31089 confirmed.......................86239 177.1590 Regulation at 87 FR 31089 confirmed.......................86239 177.2420 Regulation at 87 FR 31089 confirmed.......................86239 177.2600 Regulation at 87 FR 31089 confirmed.......................86239 178.3740 Regulation at 87 FR 31089 confirmed.......................86239 178.3910 Regulation at 87 FR 31089 confirmed.......................86239 180.30 Removed.....................................................55045 184 Notification...................................................33229 186 Notification...................................................33229 201 Authority citation revised.....................................51767 201.1 (b) revised; eff. 12-18-25...................................51767 201.10 (d)(2) revised; eff. 12-18-25...............................51767 201.51 (a) and (b) revised; eff. 12-18-25..........................51768 201.67 Added......................................................105329 201.67 Regulation at 89 FR 105329 eff. date delayed to 3-21-25..............................................8173 201.105 Introductory text revised; eff. 12-18-25...................51768 201.130 Added.....................................................105329 201.130 Regulation at 89 FR 105329 eff. date delayed to 3-21-25..............................................8173 201.161 Revised; eff. 12-18-25.....................................51768 201.328 (a) introductory text and (1) introductory text revised; (d) added; eff. 12-18-25.......................................51769 210 Authority citation revised.....................................51769 210.1 (a) and (b) revised; eff. 12-18-25...........................51769 210.2 (a) and (b) revised; eff. 12-18-25...........................51769 211 Authority citation revised.....................................51769 211 Notification.....................................................563 211.1 (a) revised; eff. 12-18-25...................................51769 211.94 (e) removed; eff. 12-18-25..................................51769 211.125 (c) revised; eff. 12-18-25.................................51769 211.132 (c)(1) introductory text revised; eff. 12-18-25............51769 211.170 (b) introductory text revised; eff. 12-18-25...............51770 211.196 Revised; eff. 12-18-25.....................................51770 213 Added; eff. 12-18-25...........................................51770 230 Added; eff. 12-18-25...........................................51777 314 Authority citation revised.....................................51782 [[Page 32]] 314.1 (c) redesignated as (d); new (c) added; eff. 12-18-25........51782 314.56 Added......................................................105330 314.56 Regulation at 89 FR 105330 eff. date delayed to 3-21-25..............................................8173 314.81 (b)(3)(v) added............................................105331 314.81 Regulation at 89 FR 105331 eff. date delayed to 3-21-25..............................................8173 314.125 (b)(20) added.............................................105331 314.125 Regulation at 89 FR 105331 eff. date delayed to 3-21-25..............................................8173 314.127 (a)(15) added.............................................105331 314.127 Regulation at 89 FR 105331 eff. date delayed to 3-21-25..............................................8173 510.600 (c)(1) table and (2) table amended...........42356, 85425, 95103 510.600 (c)(1) table and (2) table amended..........................6799 514 Authority citation revised.....................................51782 514.1 (a) amended; eff. 12-18-25...................................51782 514.80 Introductory text table amended; (a)(6) added; eff. 12-18- 25.............................................................51782 515.10 (c) and (e) revised.........................................51966 516.155 (a) and (b) revised........................................42362 516.1760 (a) revised...............................................85426 516.2475 Added.....................................................85426 520.35 (a) and (c)(2) revised.......................................6799 520.88 Heading and (a) revised; (b)(3) added.......................42357 520.100 (b)(2) revised; (b)(3) removed.............................85426 520.304 (a)(4) and (b)(4) added; (b)(1) revised....................42357 520.304 (b)(2) amended.............................................95103 520.522 (b)(4) amended.............................................95103 520.645 Removed....................................................42357 520.804 Removed....................................................42357 520.870 Removed....................................................42357 520.928 Heading revised............................................42357 520.929 Added......................................................42357 520.998 (c)(2)(ii) revised..........................................6800 520.1136 Added.....................................................95103 520.1196 (b) revised...............................................42357 520.1198 (a)(3) and (b)(3) removed.................................42357 520.1287 Added......................................................6800 520.1315 (b) revised...............................................85426 520.1372 Redesignated as 520.1375..................................95103 520.1375 Redesignated from 520.1372 and heading revised............95103 520.1376 Added.....................................................95103 520.1720e (b)(1) amended............................................6800 520.1760 (b) revised...............................................85426 520.1780 Heading revised...........................................42357 520.1780 (b) revised...............................................85426 520.1782 Added.....................................................42357 520.2086 (c)(1) and (2) revised.....................................6800 520.2090 (a)(1) revised............................................95103 520.2090 (c)(2) revised.............................................6800 520.2130 (d)(1)(ii) and (2)(ii) amended............................85426 520.2598 (a) revised...............................................85426 520.2604 (b) revised...............................................85426 522.147 (b) revised................................................42357 522.304 (b) revised................................................85426 522.313c (b) revised...............................................95103 522.772 (d)(1)(ii) revised; (d)(1)(iii) amended....................85426 522.840 (d) revised................................................42357 522.870 Removed....................................................42358 522.955 (b)(3) and (d)(1)(ii)(C) amended...........................85426 522.970 (b)(1) and (3) revised.....................................85426 522.1182 (b)(7) introductory text revised..........................85427 522.1450 (b) revised...............................................95103 522.1696b (d)(2)(iii)(B) revised...................................85427 522.1860 Added.....................................................85427 522.1940 Revised...................................................42358 522.2005 (b), (c) heading, and (2) revised; (d) added...........................................................6800 522.2343 Revised...................................................42358 522.2470 Heading and (b) revised...................................95103 522.2477 Revised...................................................42359 522.2478 (a)(1)(i) and (ii) redesignated as (a)(1)(ii) and (iii); new (a)(1)(i) and (d)(3) added; (d)(1)(i)(A), (B), and (D) revised........................................................85427 522.2478 (d)(2) revised.............................................6801 522.2630 (b)(1) and (2) amended....................................95103 522.2630 (b)(1) and (2) amended.....................................6801 522.2694 Added.....................................................85428 524.770 (b) revised.................................................6801 524.802 (b) revised................................................85428 524.1193 (d) removed; (e) redesignated as new (d); (b), new (d)(2), and new (3) revised....................................42360 524.1580a (b)(1) amended...........................................95103 524.1580c Removed..................................................95103 524.2098 (b) revised...............................................42360 524.2099 (c)(2) revised.............................................6801 524.2338 Added.....................................................42360 529.1004 (d)(2)(ii) table footnote 1 revised.......................85428 529.1150 (c)(1)(iv) revised........................................85428 [[Page 33]] 529.1186 (b) revised...............................................42360 529.2110 (b) revised...............................................42360 529.2620 (b) amended................................................6801 556.275 (b)(6) added...............................................85428 556.530 added......................................................85428 558.6 (c)(7) revised...............................................51966 558.128 (e)(4)(ii), (vi), (viii), (xxviii), (xxxi), (xxxii), (xxxv), (xxxvi), (xxxix), (xli), (xlii), (l), (lii), (liv), (lvi), (lvii), (lix), and (lx) revised.........................95103 558.128 (e)(4)(xxi) and (xxii) revised..............................6801 558.258 (e)(1) heading and (5)(iv) added...........................85428 558.261 (e)(2)(ii) revised.........................................85428 558.261 (b) revised.................................................6802 558.330 (d) redesignated as (e); new (d) added; new (e) revised.................................................6802 558.342 (b)(1) and (2) added; (e)(1)(i) and (ii) revised.........................................................6803 558.355 (f) redesignated as (e); (b)(1), (2), (d)(9)(i) heading, (ii) heading, (10)(i), (ii), new (e)(1)(i), new (ii), new (2)(i), and new (5) revised; new (e)(6) removed; new (e)(7) redesignated as new (e)(6).....................................95107 558.450 (e)(5)(iv) through (vi) revised............................85429 558.485 (e)(2) revised.............................................42360 558.500 (b)(1), (2), and (e)(1)(i) revised.........................42361 558.625 (e)(2)(ix) through (xvii) redesignated as (e)(2)(x) through (xviii); new (e)(2)(ix) added...........................................................6804 573.420 (b) revised................................................48508 573.450 (a) amended................................................67856 573.500 (a) amended................................................33231 573.587 Redesignated from 573.750; new heading and new (a) revised 72315 573.750 Redesignated as 573.587....................................72315 630 Notification...................................................58274 803 Notification...................................................70096 809 Authority citation revised.....................................37444 809.3 (a) amended..................................................37445 820.3 Correction: Amended; eff. 2-2-26.............................82945 862.1676 Added.....................................................72983 862.3245 Added.....................................................75491 864.7295 Added.....................................................72317 866.3180 Added.....................................................77450 866.3183 Added.....................................................75954 866.3236 Added.....................................................75493 866.3966 Added.....................................................66558 866.3981 Added.....................................................66554 866.6000 Added.....................................................73566 870.5600 Added.....................................................72319 872.5575 Added.....................................................71154 872.6866 Added.....................................................72321 876.4330 Added.....................................................72986 876.5861 Added.....................................................75496 876.5862 Added.....................................................72716 880.5220 Added.....................................................66560 882.5803 Added.....................................................71156 886.5350 Added.....................................................43746 886.5919 Added.....................................................72323 888.3085 Added.....................................................71158 890.3050 Added.....................................................71160 900 Notification...................................................68364 1140 Authority citation revised....................................70486 1140.10--1140.16 (Subpart B) Heading revised.......................70486 1140.14 Nomenclature change........................................70486 1140.16 (c)(2)(ii) amended.........................................70486 1141 Notification..................................................74831 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1306.28 Added.......................................................6522 1306.29 Added.......................................................6522 1306.30 Added.......................................................6522 1306.31 Added.......................................................6522 1306.32 Added.......................................................6522 1306.33 Added.......................................................6522 1306.34 Added.......................................................6522 1306.35 Added.......................................................6522 1306.36 Added.......................................................6522 1306.37 Added.......................................................6522 1306.38 Added.......................................................6522 1306.39 Added.......................................................6522 1306.40 Added.......................................................6522 1306.41 Added.......................................................6522 1306.42 Added.......................................................6522 1306.43 Added.......................................................6522 1306.44 Added.......................................................6522 1306.45 Added.......................................................6522 1306.46 Added.......................................................6522 1306.47 Added.......................................................6522 1306.48 Added.......................................................6522 1306.49 Added.......................................................6522 1306.51 Undesigned center heading and section added...........................................................6522 1306.51 Regulation at 90 FR 6539 eff. date delayed 9841 1306.52 Added.......................................................6539 [[Page 34]] 1307.41 Revised; eff. through 12-31-25.............................91257 1308 Order.........................................................25517 1308.11 (b)(95) through (103) redesignated as (b)(98) through (106); (b)(69) through (94) redesignated as (b)(71) through (96); (b)(40) through (68) redesignated as (b)(41) through (69); new (b)(40), new (70), and new (97) added; (h)(51), (55), and (56) removed.........................................25517 1308.11 (h)(68) and (69) added (temporary).........................60822 1308.11 (f)(6) through (12) redesignated as (f)(7) through (13); new (f)(6) added...............................................84285 1308.11 (b)(62) through (106), (44) through (61), and (24) through (43) redesignated as (b)(65) through (109), (46) through new (63), and (25) through new (44); new (b)(24), new (45), and new (64) added; (h)(50), (52), and (53) removed................85050 1308.11 (h)(70) through (76) added (temporary)....................106314 1308.14 Regulation at 88 FR 74352 confirmed........................65993 Proposed Rules: 1--1299 (Ch. I)....................................................65294 1...........................................................51281, 66647 16.................................................................77058 26.................................................................77062 73...................................................43349, 58304, 63330 74.................................................................77467 80..........................................................32384, 46042 101.................................................................5426 106.................................................................1052 117................................................................47108 ..................................................................1052 172...............................................................104908 173................................................................78836 175................................................................86290 176................................................................86290 177..................................................32386, 60336, 86290 178................................................................86290 179...............................................................100404 201................................................................44944 500................................................................44944 501................................................................44944 510................................................................44944 514................................................................44944 516................................................................44944 730...............................................................105490 809................................................................37158 866................................................................78265 1160................................................................5032 1300................................................................6541 1301...............................................................70148 ..................................................................6541 1304................................................................6541 1306................................................................6541 1308...................24750, 25544, 44597, 48515, 75979, 106376, 106384 1310...............................................................85459