[List of CFR Sections Affected (LSA), March 2012] [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............................11-58398, 11-61565 1 Authority citation revised.....................................12-5176 Policy statement..............................................12-10662 1.21 (a) introductory text and (c)(1) revised....................12-5176 1.101 (a) and (b) heading revised................................12-5176 1.281 (a)(18), (b)(12) and (c)(19) added; interim...............11-25545 1.361 Revised; interim..........................................12-10662 1.378 Revised; interim..........................................11-25541 1.393 (a) revised; interim......................................11-25541 5 Revised.......................................................12-15962 5.111 (b) revised...............................................11-31469 7.3 (f) amended..................................................12-5176 10.85 (d)(4) amended............................................11-31469 10.90 (d) amended...............................................11-31469 10.95 Amended...................................................11-31469 14.65 (c) amended...............................................11-31469 14.100 (c)(15) revised..........................................11-45403 (c)(1) heading and (ii) amended...............................11-53817 16.1 (b)(2) amended.............................................11-38974 (b)(1) amended.................................................12-5176 19.10 (d) introductory text amended.............................11-31469 20.3 (b) revised................................................11-31469 20.26 (b) revised...............................................11-31469 20.30 Revised...................................................11-31469 20.40 (a) revised; (c) amended..................................11-31469 20.41 (a), (b) introductory text and (c) amended................11-31469 20.107 (a) amended..............................................11-31469 20.108 Amended..................................................11-31470 (c) removed; (d) redesignated as new (c); (b) and new (c) revised; eff. 8-6-12............................12-16925 20.120 (a), (b) introductory text and (4) revised...............11-31470 21.32 (b)(2) amended............................................11-31470 21.40 (b) amended...............................................11-31470 21.41 Amended...................................................11-31470 21.43 (a)(2) amended............................................11-31470 25.32 (p) revised...............................................11-59248 50.23 (e)(3) revised............................................11-36993 73.3129 Added...................................................11-25235 Regulation at 76 FR 25235 eff. date confirmed.................11-59503 101 Policy statement.............................................12-9842 113.40 (g)(2)(i)(A) corrected...................................11-81363 165.110 (b)(4)(iii)(C) table amended; (b)(4)(iii)(F) introductory text revised; (b)(4)(iii)(F)(21) and (22) added; eff. 4-16-12 11-64813 172.870 (a)(1) and (b)(1) revised...............................11-41689 173.375 Introductory text revised...............................11-59248 175.105 (c)(5) table amended....................................11-59248 175.300 (d) Table 2 revised.....................................11-59248 177.1210 (c) Table 4 revised....................................11-59249 177.2600 (c)(4)(ix) amended.....................................11-59249 178.3130 (b) table amended......................................11-59249 179 Response to objections......................................11-20509 182.99 Revised..................................................11-59249 184.1155 (a) amended............................................11-59249 184.1165 (a) amended............................................11-59249 184.1261 (a) amended............................................11-59249 184.1446 (a) amended............................................11-59249 184.1446 (a) amended............................................11-59250 184.1449 (a) amended............................................11-59250 184.1845 (a) amended............................................11-59250 201 Policy statement............................................11-35665 201.26 Regulation at 72 FR 73599 confirmed.......................12-5699 201.66 (c)(5)(ii)(B) revised....................................11-44487 201.327 Added; eff. 6-18-12.....................................11-35660 (i)(1)(ii)(A)(2) and (3) corrected............................11-38975 211.122 (g) introductory text revised; (g)(4) added; eff. in part 4-19-12.................................12-16163 310 Policy statement............................................11-35665 310.545 (a)(29) and (d)(31) revised; (d)(40) added; eff. 6-18-12 11-35665 312 Policy statement............................................11-32863 312.6 Regulation at 72 FR 73599 confirmed........................12-5699 314.53 (e) amended..............................................11-31470 314.70 Regulation at 72 FR 73600 confirmed.......................12-5699 [[Page 32]] 314.81 (b)(3)(iii)(a) amended; (b)(3)(iii)(b) revised; (b)(3)(iii)(d) added; interim...............................11-78539 320 Policy statement............................................11-32863 333 Policy statement............................................11-36307 341.76 (b), (c) and (d) revised.................................11-44487 350.60 Amended..................................................11-31470 500.1410 (Subpart F) Added......................................11-72618 500.1410 (a) correctly amended...................................12-9528 501.22 (k) added................................................11-71254 510.600 (c)(1) table and (2) table amended...........11-39278, 11-40612, 11-79064 (c)(1) table and (2) table amended...........12-4224, 12-4896, 12-5700 516.20 (b)(2) correctly revised; CFR correction.................12-18685 516.157 (a) amended.............................................11-31470 520.100 (b)(4) added............................................11-38554 (b)(4) revised................................................11-40808 520.154a Heading, (d)(1)(i), (2)(i), (ii), (A) and (4)(i) correctly revised...........................................11-53050 520.390a Revised.................................................12-4896 520.441 Redesignated from 520.445b; (b)(2) and (3) revised; (d)(4)(iii)(C) amended......................................11-49963 (b)(4) amended.................................................12-5700 520.443 Redesignated from 520.445c; (d) removed; (e) redesignated as new (d); (a), (b) and new (d) introductory text revised 11-49963 520.445 Revised.................................................11-49649 520.445a Removed................................................11-49649 520.445b Redesignated as 520.441................................11-49649 520.445c Redesignated as 520.443................................11-49649 520.522 (a) and (d) revised.....................................11-78815 520.538 (a), (d)(1) and (2) revised..............................12-3928 520.622a (a)(4) removed..........................................12-4896 520.622b (b) removed.............................................12-4897 520.852 Added...................................................11-78150 520.970 Correctly revised.......................................11-53051 520.970a Correctly removed......................................11-53051 520.970b Correctly removed......................................11-53051 520.1044c Revised................................................12-4226 520.1447 Added...................................................12-4225 520.1454 (b) and (d) revised....................................11-48714 520.1705 Added..................................................12-15960 520.1720c (b)(1) amended.........................................12-4897 520.1760 Added..................................................12-15961 520.2045 (b)(2) amended.........................................11-40229 520.2075 Added..................................................11-18648 520.2640 (a), (b)(1), (2), (d)(2)(ii), (3)(ii)(A), (B) and (iii) revised; (b)(3) added.......................................11-59024 522.90b (d)(2)(iii) correctly revised...........................11-53051 522.522 (d)(1) and (2) revised...................................12-4227 522.812 (e)(2)(ii) revised......................................11-22611 522.814 Added...................................................11-72618 522.1014 Added..................................................11-57906 522.1083 Added..................................................11-27889 Heading and (a) correctly revised.............................11-53051 (c)(1) and (3) revised.........................................12-4227 522.1192 (b)(2) revised.........................................11-57906 522.1410 Heading, (a) and (d) correctly revised; (c) correctly removed.....................................................11-53051 522.1450 (d) redesignated as (e); new (d) added; (b) and new (e)(1) and (3) revised......................................11-48714 522.1696a (b)(1), (3), (d)(1)(iii) and (2)(iii) revised......................................................12-4897 522.2260 (a), (d)(1) and (3) correctly revised..................11-53051 522.2690 (b) amended............................................11-79064 524.390 Revised..................................................12-4897 524.390a Removed.................................................12-4897 524.390b Removed.................................................12-4897 524.390d Removed.................................................12-4897 524.814 Revised.................................................11-72619 524.1044f (b) and (c)(2) revised.................................12-3598 524.1132 Added..................................................11-78150 524.1193 (b)(1) and (2) amended.................................11-81807 524.1450 Redesignated from 524.1451; (a), (b) and (e)(1) revised 11-48715 524.1451 Redesignated as 524.1450...............................11-48715 524.1484a Removed................................................12-4897 524.1484j Removed................................................12-4897 524.1484k Removed................................................12-4897 524.1880 Removed.................................................12-4897 529.1455 Removed.................................................12-4897 530.41 (a)(13) added; eff. 4-5-12.................................12-745 556.227 (b) revised; (c) added..................................11-72619 556.292 Added...................................................11-57907 556.540 Revised.................................................11-57907 558.4 (d) table amended.........................................11-76894 558.274 (a)(7) removed; (c)(1)(i) table and (ii) table amended................................................12-4897 558.342 (d)(2) revised; (e)(1) table amended....................11-60721 (e)(1) table amended..........................................11-65110 558.355 (f)(3)(x) introductory text and (b) revised.............11-79065 [[Page 33]] (f)(3)(iv) added; (f)(3)(x)(c) amended.........................12-4228 558.485 (b)(3) amended...........................................12-4897 558.500 (e)(1)(i) correctly reinstated; CFR correction..................................................12-14272 558.618 (a), (c) and (e) revised................................11-76894 558.625 (b)(10), (12) and (67) removed...........................12-4897 558.630 (b)(2) removed; (b)(5) amended...........................12-4897 601.12 Regulation at 72 FR 73600 confirmed.......................12-5699 606 Technical correction.........................................12-6463 606.120--606.122 (Subpart G) Revised...............................12-16 606.121 Revised....................................................12-16 606.122 Heading, introductory text, (e), (f), (k) introductory text, (l) introductory text, (m) introductory text, (2), (3), (5) and (n) introductory text revised......................................12-18 606.170 (b) revised................................................12-18 610 Technical correction.........................................12-6463 610.15 (d) added................................................11-20518 610.40 (h)(2)(ii)(B) and (i) revised...............................12-18 610.68 Regulation at 72 FR 73600 confirmed.......................12-5699 640 Technical correction.........................................12-6463 640.70 Removed.....................................................12-18 640.74 (b)(4) revised..............................................12-18 800 Policy statement............................................11-28308 801.128 Regulation at 72 FR 73601 confirmed......................12-5699 807.81 Regulation at 72 FR 73601 confirmed.......................12-5699 809.11 Regulation at 72 FR 73601 confirmed.......................12-5699 812.5 Regulation at 72 FR 73602 confirmed........................12-5699 814.39 Regulation at 72 FR 73602 confirmed.......................12-5699 814.45 (d)(2) amended...........................................11-31470 814.84 Regulation at 72 FR 73602 confirmed.......................12-5699 866 Technical correction........................................11-22322 866.3305 (b) revised............................................11-48717 866.3395 Added; eff. 4-9-12.....................................12-14274 866.6050 (c) added..............................................11-82131 870.2360 (b) revised............................................11-43585 870.3460 Added...................................................12-8119 870.3545 (c) revised............................................11-50666 870.3710 (c) revised............................................11-50666 874.3305 Added..................................................11-34846 878 Technical correction........................................11-29153 878.4590 Added..................................................11-43121 878.5400 Added..................................................11-20842 878.5650 Revised................................................11-22807 882.1935 Added; eff. 4-23-12....................................12-16927 882.5805 Added..................................................11-44491 882.5975 (c) added..............................................11-36993 884.5200 Added..................................................11-21238 884.5330 (c) revised............................................11-50667 886.5200 Added..................................................11-51878 1107 Added......................................................11-38974 1141 Added......................................................11-36753 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1300 Policy statement...........................................11-64813 1300.01 (b) revised..............................................12-4230 1300.02 (b) revised..............................................12-4233 1301.13 (e)(1) revised; eff. 4-16-12............................12-15249 1301.52 (a) revised.............................................11-61564 1303.11 (c) amended..............................................12-4235 1304 Policy statement...........................................11-64813 1304.03 (a) amended..............................................12-4235 1305.03 (d) revised..............................................12-4235 1306 Policy statement...........................................11-64813 1306.24 Heading revised..........................................12-4235 1308 Order......................................................12-12201 1308.11 (g)(6), (7) and (8) added...............................11-65374 1308.11 (d)(8) revised...........................................12-4235 1308.12 (b)(4) revised...........................................12-4235 1308.13 (b) introductory text revised............................12-4236 1308.14 (c)(5) through (52) redesignated as (c)(6) through (53); new (c)(5) added............................................11-77358 1308.15 (e)(1) and (2) redesignated as (e)(2) and (3); new (e)(1) added.......................................................11-77899 1309 Authority citation revised.................................12-15250 1309.11 Revised; eff. 4-16-12...................................12-15250 1309.21 (a)(2) revised...........................................12-4236 (c) revised; eff. 4-16-12.....................................12-15250 1309.24 (b), (c) and (d) revised.................................12-4236 1309.62 (a) revised.............................................11-61564 (a) amended....................................................12-4236 1310.04 (f)(1)(ii) revised; (g) amended..........................12-4236 1310.05 (d) amended; (f)(2) revised..............................12-4236 1310.06 (e)(1), (4), (f)(1), (4) and (h)(5) revised......................................................12-4236 1310.09 (m) added...............................................11-31829 (b) amended....................................................12-4237 [[Page 34]] 1310.10 Heading revised; (a) amended.............................12-4237 1310.12 (a) revised; (c) table amended..........................11-31830 1310.13 (e) and (i) introductory text revised...................11-31830 1310.14 Introductory text revised................................12-4237 1311 Policy statement...........................................11-64813 1312.18 (d) revised..............................................12-4237 1312.21 (c) revised..............................................12-4237 1312.25 Amended..................................................12-4237 1312.28 (c) revised..............................................12-4237 1313.12 (d) revised..............................................12-4237 1313.13 (c)(1) revised...........................................12-4237 1313.14 (c) revised..............................................12-4237 1313.21 (c)(1) revised...........................................12-4237 1313.24 (a) revised..............................................12-4237 1313.31 (b)(5) and (11) revised..................................12-4237 1313.32 (b)(2) revised...........................................12-4238 1313.33 (c)(1) and (4) revised...................................12-4238 1314.30 Revised.................................................11-74698 1314.45 Introductory text revised................................12-4238 1314.101 Added; interim.........................................11-20523 1314.102 Added; interim.........................................11-20523 1314.103 Added; interim.........................................11-20524 1314.115 (a)(2) revised..........................................12-4238 1316.03 (d) revised..............................................12-4238 1316.42 (g) revised..............................................12-4238 Proposed Rules: 1--1299 (Ch. I)...................11-20568, 11-20588, 11-23520, 11-32330 ..............................................................12-13513 1...............................................................11-20901 7...............................................................11-20901 10........................................................12-25, 12-3653 11...................................11-19192, 11-19238. 30050, 11-30051 16..........................................11-20575, 11-20901, 11-41157 20.....................................................12-3653, 12-16971 25...............................................................12-3653 50....................................................11-44512, 11-54408 56....................................................11-44512, 11-54408 73....................................................11-49707, 11-55321 .....................................................12-2935, 12-16784 101..........11-19192, 11-19238, 11-30050, 11-30051, 11-37291, 11-46671, 11-49707 118.............................................................11-41157 172.............................................................11-78866 .....................................................12-2492, 12-13232 173.....................................................12-2492, 12-5201 177..............................................................12-9608 178..............................................................12-2492 180..............................................................12-2492 201.........................................11-35672, 11-35678, 11-66235 202....................................................12-4273, 12-16973 203.............................................................11-41434 310.............................................................11-35678 312.............................................................11-20575 316.............................................................11-64868 352...................................................11-35669, 11-56682 510..............................................................12-3653 511.............................................................11-20575 573...................................................11-32332, 11-48751 579.............................................................12-12226 600.............................................................11-36019 610...................................................11-36019, 11-66235 680.............................................................11-36019 812.............................................................11-20575 866.........................................11-28688, 11-28689, 11-69034 ..............................................................12-16126 870.....................11-44872, 11-47085, 11-48058, 11-53851, 11-64224 876..............................................................12-9610 882.............................................................11-48062 1140........................................11-55835, 11-71281, 11-76096 1300--1399 (Ch. II)...................................11-34003, 11-40552 1300............................................................11-72355 1301............................................................11-39318 1308........................................11-39039, 11-55616, 11-65424 ..............................................................12-12508 1309............................................................11-39318 1316............................................................11-26660