[List of CFR Sections Affected (LSA), November 2015] [From the U.S. Government Publishing Office, www.gpo.gov] TITLE 21_FOOD AND DRUGS Chapter I_Food and Drug Administration, Department of Health and Human Services (Parts 1_1299) 1 Technical correction..........................................15-22403 Compliance date clarification.................................15-71934 Authority citation revised..........................15-74340, 15-74650 1.94 Revised....................................................15-55242 1.101 (d)(2)(i) amended.........................................15-18090 1.227 Revised...................................................15-56141 1.241 (a) revised...............................................15-56143 1.276 (b)(9) revised............................................15-56143 1.328 Amended...................................................15-56143 1.363 Revised...................................................15-56144 1.500--1.514 (Subpart L) Added..................................15-74340 1.600--1.695 (Subpart M) Added..................................15-74650 11 Compliance date clarification................................15-71934 11.1 Regulation at 79 FR 71253 and 71291 compliance date extended....................................15-39675 (i) added.....................................................15-56144 (j) added.....................................................15-56336 (l) added.....................................................15-74352 (k) added.....................................................15-74547 (m) added.....................................................15-74667 14.100 (c)(2) introductory text revised.........................15-18307 16 Technical correction.........................................15-22403 Authority citation revised....................................15-42723 Compliance date clarification.................................15-71934 16.1 (b)(2) amended...................................15-56144, 15-56336 (b)(1) and (2) amended........................................15-74547 (b)(2) amended................................................15-74667 20.100 (c)(45) added............................................15-38938 25 Technical correction.........................................15-70679 25.15 (a), (c) and (d) amended..................................15-57535 25.20 Introductory text revised; (o) and (p) added 15-57535 25.30 Introductory text amended.................................15-57535 25.35 Added.....................................................15-57535 25.40 (a) amended...............................................15-57535 25.50 (b) amended...............................................15-57535 25.52 (a) amended; (b) and (c) revised..........................15-57535 26.1--26.21 (Subpart A) Appendix E amended......................15-18090 73.200 Regulation at 80 FR 14842 eff. date confirmed...................................................15-31466 73.350 (c)(1)(ii) revised; (c)(1)(iii) added....................15-32307 Regulation at 80 FR 32307 confirmed...........................15-46190 (c)(1)(ii)(A) revised.........................................15-58602 73.530 (c) revised..............................................15-50765 Regulation at 80 FR 50765 eff. date confirmed.................15-66415 73.1530 Added...................................................15-50765 Regulation at 80 FR 50765 eff. date confirmed.................15-66415 99.201 (c)(1) amended...........................................15-18090 101.8 Regulation at 79 FR 71291 compliance date extended....................................................15-39675 101.9 Regulation at 79 FR 71253 and 71291 compliance date extended....................................15-39675 101.10 Regulation at 79 FR 71253 compliance date extended....................................................15-39675 101.11 Regulation at 79 FR 71253 compliance date extended....................................................15-39675 106 Compliance date clarification...............................15-71934 [[Page 64]] 106.100 (n) revised.............................................15-56144 107.10 (a)(2) revised...........................................15-35840 Regulation at 80 FR 35840 eff. date confirmed; eff. 6-22-16................................................15-61293 107.100 (a) revised.............................................15-35841 Regulation at 80 FR 35841 eff. date confirmed; eff. 6-22-16................................................15-61293 110 Removed; eff. 9-17-18.......................................15-56144 Compliance date clarification.................................15-71934 111.5 Amended...................................................15-74352 112 Added.......................................................15-74547 Policy statement..............................................15-74670 114 Compliance date clarification...............................15-71934 114.5 Revised...................................................15-56144 117 Added.......................................................15-56145 Policy statement..............................................15-56358 Compliance date clarification.................................15-71934 117.3 Eff. date pending in part.................................15-56145 117.5 Eff. date pending in part.................................15-56145 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 117.8 Eff. date pending in part.................................15-56145 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 117.95 Added....................................................15-56337 117.405 Eff. date pending in part...............................15-56145 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 117.410 Eff. date pending in part...............................15-56145 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 117.430 Eff. date pending in part...............................15-56145 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 117.435 Eff. date pending in part...............................15-56145 117.475 Eff. date pending in part...............................15-56145 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 120 Compliance date clarification...............................15-71934 120.3 Introductory text amended.................................15-56167 120.5 Revised...................................................15-56167 120.6 (b) amended...............................................15-56167 123 Compliance date clarification...............................15-71934 123.3 Introductory text amended.................................15-56167 123.5 (a) revised...............................................15-56167 123.11 (b) introductory text revised............................15-56167 129 Compliance date clarification...............................15-71934 129.1 Revised...................................................15-56167 150.141 Removed.................................................15-72585 150.161 Removed.................................................15-72585 161.170 (a)(5)(ii)(b) removed; (a)(5)(ii)(a) redesignated as (a)(5)(ii)..................................15-41436 172.185 (a) revised; (b) and (c) redesignated as (c) and (d); new (b) added..................................15-34276 179 Compliance date clarification...............................15-71934 179.25 (a) revised..............................................15-56168 201.25 (d)(2) amended...........................................15-18090 201.58 Amended..................................................15-18090 203.12 Revised..................................................15-18090 203.37 (e) revised..............................................15-18090 203.70 (b)(2) revised...........................................15-18091 206.7 (b)(1)(i) amended.........................................15-18091 207.7 (a) amended...............................................15-18091 211 Compliance date clarification...............................15-71934 211.1 (c) amended...............................................15-56168 310 Authority citation revised..................................15-38938 310.305 Regulation at 79 FR 33087 eff. date delayed.....................................................15-30151 310.306 Added...................................................15-38938 310.503 (f)(3) amended..........................................15-18091 312.140 (a)(3) amended..........................................15-18091 312.145 (b) amended.............................................15-18091 312.310 (d)(1) amended..........................................15-18091 314 Regulation at 79 FR 33088 eff. date delayed.................15-30151 Authority citation revised....................................15-38938 314.80 Regulation at 79 FR 33088 eff. date delayed 15-30151 314.81 (b)(3)(iii) revised......................................15-38938 314.91 Removed..................................................15-38939 314.98 Regulation at 79 FR 33089 eff. date delayed 15-30151 314.440 (b) introductory text revised...........................15-18091 317 Order.......................................................15-50559 329 Regulation at 79 FR 33089 eff. date delayed.................15-30151 500.23 Revised..................................................15-56337 507 Added.......................................................15-56337 Policy statement..............................................15-56360 507.3 Eff. date pending in part.................................15-56337 507.12 Eff. date pending in part................................15-56337 [[Page 65]] Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 507.105 Eff. date pending in part...............................15-56337 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 507.110 Eff. date pending in part...............................15-56337 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 507.130 Eff. date pending in part...............................15-56337 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 507.135 Eff. date pending in part...............................15-56337 507.175 Eff. date pending in part...............................15-56337 Regulation at 80 FR 56145 eff. date confirmed in part........................................................15-74354 510.600 (c)(1) table and (2) table amended...........15-18775, 15-34278, 15-61295, 15-73104 514 Authority citation revised..................................15-31733 514.1 (b)(9) revised............................................15-31733 520.43 (c)(2) revised...........................................15-18775 520.48 (b) revised..............................................15-34278 520.88g (c)(2)(i) amended.......................................15-34278 520.154a Heading revised; (d)(1)(ii), (2)(i)(A), (ii)(A), (3)(ii) and (4)(ii) amended........................15-34278 520.304 (b)(3) amended..........................................15-34278 (b)(2) amended................................................15-61296 520.441 (b)(4) amended..........................................15-18775 520.804 (c)(i), (ii) and (iii) redesignated as (c)(1), (2) and (3).........................................15-34278 520.1156 Added..................................................15-18775 520.1315 (c)(1) revised.........................................15-53459 520.1367 (b)(2) amended.........................................15-53459 520.1443 (b) amended............................................15-18776 520.1447 (b) amended............................................15-18776 520.1510 Heading and (b) revised; (d)(1)(ii)(B) amended.....................................................15-18776 520.1660d (a)(4) revised........................................15-34278 520.1855 (b) amended............................................15-34278 (c)(1) revised................................................15-53459 520.2158 (b) amended............................................15-18776 (d)(1) and (2) revised; (d)(3) added..........................15-61296 520.2218 (d)(1)(i)(A), (B), (2)(i)(A) and (B) revised.....................................................15-34278 520.2261b (d)(4)(iii) amended...................................15-61296 520.2598 (a) amended............................................15-53460 520.2640 (e)(2)(iii) and (3)(iii) amended.......................15-34278 522 Drug application approval withdrawn.........................15-18777 522.167 Added...................................................15-18776 522.230 (b) amended.............................................15-18776 522.690 (d)(1) and (2) redesignated as (d)(2) and (4); new (d)(1) added; new (d)(2)(ii) and (3)(ii) amended; (a), (b), (c) and new (d)(4) introductory text revised...................................15-61296 522.812 (b)(3) added............................................15-18776 (b)(2) revised................................................15-61296 522.955 (a), (b), (d)(1) heading, (i) introductory text, (C), (ii) introductory text and (C) revised.....................................................15-61296 522.1004 Removed................................................15-18776 522.1073 Removed................................................15-34278 522.1075 Removed................................................15-34278 522.1077 Revised................................................15-34279 522.1145 (e)(2)(i) amended......................................15-34279 522.1289 (a) amended............................................15-61297 522.2005 (b)(2) revised; (b)(3) removed.........................15-18776 522.2075 Added..................................................15-61297 522.2470 (b) revised............................................15-34279 522.2483 (b) revised............................................15-34279 524.154 (a)(1), (2) and (b)(2) revised..........................15-61297 524.1044a Revised...............................................15-18776 524.1450 (a), (b) and (d) revised; (e) removed..................15-53460 524.1484g (a) and (b) revised...................................15-61297 526.313 (d)(1)(ii) revised......................................15-34279 528.1070 (b) amended............................................15-34279 528.1092 Added..................................................15-73104 529.1186 (b) amended............................................15-18776 529.1350 (b) amended............................................15-18776 529.2150 (b) amended............................................15-18776 556.68 Added....................................................15-61297 558 Authority citation revised..................................15-31733 Policy statement..............................................15-58602 Drug application approvals withdrawn..........................15-61298 558.3 (b)(1)(ii), (6), (7), (9) and (11) revised; (b)(12) added...............................................15-31733 558.4 (d) table amended.........................................15-61297 558.6 Revised...................................................15-31733 (b)(5) and (c) introductory text corrected....................15-35841 558.68 Added....................................................15-61297 558.95 (d)(4)(ii) table amended.................................15-53460 558.128 (b)(2), (e)(1) table, (2) table, (3) table, (iv) and (4) table amended...........................15-18776 558.460 (a) and (b) revised.....................................15-61298 [[Page 66]] 558.500 (e)(1)(ii), (iii), (iv), (2)(iv), (ix), (x) and (xiii) amended......................................15-61298 558.618 (e)(2)(i) amended.......................................15-61298 558.665 (e)(9) added............................................15-18776 (d)(2) and (e) revised........................................15-53460 573.490 Added...................................................15-35569 579.12 Amended..................................................15-56356 600 Regulation at 79 FR 33090 eff. date delayed.................15-30151 Authority citation revised....................................15-38939 600.2 (a), (c)(1) and (2) amended...............................15-18091 Regulation at 79 FR 33090 eff. date delayed...................15-30151 600.11 (f)(6) amended...........................................15-18092 600.14 (e)(1) revised...........................................15-18092 600.22 (e) amended..............................................15-18092 600.80 Regulation at 79 FR 33090 eff. date delayed 15-30151 600.81 Regulation at 79 FR 33091 eff. date delayed 15-30151 600.82 Added....................................................15-38939 600.90 Regulation at 79 FR 33092 eff. date delayed 15-30151 601.2 (a) amended...............................................15-18092 (c)(1) amended................................................15-37974 601.12 (f)(4) amended...........................................15-18092 601.15 Amended..................................................15-18092 601.22 Amended..................................................15-37974 601.28 Introductory text amended................................15-18092 601.29 (b) amended..............................................15-18092 601.70 (d) amended..............................................15-18092 606.3 (a) and (c) revised.......................................15-29894 606.40 (a)(1) amended...........................................15-29895 606.100 (b) introductory text and (20) revised; (b)(1) amended; (b)(21) and (22) added......................15-29895 606.110 (a) and (b) amended.....................................15-29895 606.121 (c)(11), (12), (h)(2), (3) and (i)(5) amended.....................................................15-29895 606.122 (e) amended.............................................15-29895 606.145 Added...................................................15-29895 606.160 (b)(1)(ix), (x), (xi) and (e) revised...................15-29895 606.170 (b) amended.............................................15-18092 601.171 (e) revised.............................................15-18092 607.7 (b) and (c) amended.......................................15-18092 607.22 (a) amended..............................................15-18092 607.37 Revised..................................................15-18092 610.2 (a) and (b) amended.......................................15-18093 610.11 (g)(2) amended...........................................15-18093 Removed.......................................................15-37974 610.11a Removed.................................................15-37974 610.15 (a)(3) amended...........................................15-18093 610.39--610.48 (Subpart E) Heading revised......................15-29896 610.39 Added....................................................15-29896 610.40 (a), (b), (c) heading, (e) revised; (c)(2) and (i) removed; (c)(3) and (4) redesignated as new (c)(2) and (3); new (c)(2)(i), (d), (f), (g) introductory text, (h)(1), (2)(ii) introductory text, (C), (iv) introductory text, (A), (vi) and (vii) amended...........................15-29896 610.41 (a) introductory text, (2) through (5) and (b) amended; (a)(1) revised.................................15-29897 610.42 (a) amended..............................................15-29897 610.44 (a)(1) and (2) amended...................................15-29897 610.46 (a)(2), (3), (4), (b)(2) and (3) amended.................15-29897 610.47 (a)(2), (3), (4), (b)(2) and (3) amended.................15-29897 630 Heading revised.............................................15-29898 630.1--630.3 (Subpart A) Added..................................15-29898 630.5--630.35 (Subpart B) Added.................................15-29898 630.40 (Subpart C) Subpart and heading added....................15-29898 630.6 Redesignated as 630.40....................................15-29898 630.40 Redesignated from 630.10; Heading revised; (a), (b) introductory text, (1), (3), (c), (d)(1) introductory text, (i) and (iii) amended.....................................................15-29898 640.3 Removed...................................................15-29904 640.4 (a) removed; (e) amended..................................15-29904 640.5 Introductory text and (f) amended; (a) removed.....................................................15-29904 640.12 Revised..................................................15-29904 640.14 Amended..................................................15-29904 640.21 Revised..................................................15-29904 640.22 (c) revised..............................................15-29904 640.23 (a) amended..............................................15-29904 640.27 Removed..................................................15-29904 640.31 Revised..................................................15-29904 640.32 (b) amended..............................................15-29905 640.33 (a) amended..............................................15-29905 640.51 Revised..................................................15-29905 640.52 (b) amended..............................................15-29905 640.53 (a) amended..............................................15-29905 640.61 Removed..................................................15-29905 640.62 Removed..................................................15-29905 640.63 Removed..................................................15-29905 640.64 (a) removed..............................................15-29905 [[Page 67]] 640.65 (b)(1)(i), (ii), (2)(iii) and (iv) amended; (b)(2)(i) revised...........................................15-29905 640.66 Amended..................................................15-29905 640.67 Amended..................................................15-29905 640.69 (e) and (f) added........................................15-29905 640.71 (a) introductory text and (b)(1) amended; (a)(1) through (4) removed..................................15-29905 640.72 (a)(2), (3) and (4) revised..............................15-29905 640.120 Revised.................................................15-29906 640.125--640.130 (Subpart M) Added..............................15-29906 660.3 Amended...................................................15-18093 660.6 (a)(2) and (c) heading amended............................15-18093 660.22 (b) amended..............................................15-18093 660.31 Revised..................................................15-29906 660.36 (a) introductory text, (b) and (c) amended 15-18093 660.46 (a)(2) introductory text amended.........................15-18093 660.52 Amended..................................................15-18093 680.1 (b)(2)(iii), (3)(iv) and (c) amended......................15-18093 680.3 (b) removed...............................................15-37974 801.55 (b)(1) amended...........................................15-18093 807.90 (a)(2) amended...........................................15-18094 812.19 (a)(2) amended...........................................15-18094 814.20 (h)(2) amended...........................................15-18094 814.104 (d)(2) amended..........................................15-18094 820.1 (a)(1) amended............................................15-29906 822.8 Amended...................................................15-18094 866.3130 Added..................................................15-51939 866.3365 Added..................................................15-30154 866.3860 Added..................................................15-46192 866.3990 Added..................................................15-67314 866.5940 Added..................................................15-65630 870.1415 Added..................................................15-63673 870.4360 Revised................................................15-32311 870.5700 Added..................................................15-58606 870.5910 Added..................................................15-49896 872.5560 Added..................................................15-72586 874.5900 Added..................................................15-46194 876.2050 Added..................................................15-72900 876.5025 Added..................................................15-30355 Republished...................................................15-35843 876.5140 Added..................................................15-18309 876.5930 Added..................................................15-30933 878.4670 Added..................................................15-46486 880.6600 Added..................................................15-72588 882.1470 Added..................................................15-49138 886.5905 Added..................................................15-57092 890.3110 (b) revised............................................15-72590 890.3480 Revised (republished)..................................15-25229 890.5290 (a)(1) and (b) revised; (c) removed....................15-61302 895.30 (c) revised..............................................15-31300 1020.32 (b)(4)(ii)(A) revised...................................15-19532 Regulation at 80 FR 19532 eff. date confirmed.................15-43320 1271.22 (b)(1), (3), (c)(1) and (2) amended.....................15-18094 1271.37 Revised.................................................15-18094 1271.350 (a)(5) amended; (b)(3) revised.........................15-18095 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1308 Policy statement.................................15-27854, 15-70658 Technical correction..........................................15-70680 1308.11 (h)(24) added...........................................15-42385 1308.12 (b)(4) revised..........................................15-54718 1308.14 (g)(3) added............................................15-69864 1308.22 Table amended; interim........................15-65634, 15-65637 Chapter III_Office of National Drug Control Policy (Parts 1400_1499) 1403 Regulation at 79 FR 76106 confirmed........................15-57383 1404 Regulation at 79 FR 76106 confirmed........................15-57383 1405 Regulation at 79 FR 76106 confirmed........................15-57383 Proposed Rules: 1.................................15-19160, 15-43987, 15-55802, 15-57136 2...............................................................15-36937 11....................................................15-55564, 15-57136 15....................................................15-32868, 15-54256 16..............................................................15-57136 73..............................................................15-22449 101..........15-44302, 15-44303, 15-45465, 15-54446, 15-55564, 15-63477, 15-69905, 15-71990 106.............................................................15-57136 108.............................................................15-57137 110.............................................................15-57136 114.............................................................15-57136 117.............................................................15-57136 120.............................................................15-57136 123.............................................................15-57136 129.............................................................15-57136 172.............................................................15-65978 179.............................................................15-57136 201...................................................15-57756, 15-74737 211.............................................................15-57136 [[Page 68]] 225.............................................................15-57136 299.............................................................15-52224 310.............................................................15-25166 314.............................................................15-22953 320.............................................................15-22953 500.............................................................15-57136 507.............................................................15-57136 514.............................................................15-28863 558.............................................................15-31520 573.........................................15-42069, 15-48471, 15-73153 579.............................................................15-57136 601.............................................................15-38145 801...................................................15-57756, 15-74737 866.............................................................15-71756 880.............................................................15-60809 1020............................................................15-19589 1100..............................15-37555, 15-51146, 15-57756, 15-74737 1140..................................................15-37555, 15-51146 1143..................................................15-37555, 15-51146 1271....................15-66844, 15-66845, 15-66847, 15-66849, 15-66850 1308..........15-27611, 15-29227, 15-31521, 15-48044, 15-55565, 15-70650