[List of CFR Sections Affected (LSA), February 2017] [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 Authority citation revised..................20166, 45949, 85870, 90193 Policy statement...................................39183, 57784, 88099 Nomenclature change..............................................49895 1.1 (c) amended....................................................59131 1.20 Amended.......................................................59131 1.24 Amended.......................................................59131 1.70--1.81 (Subpart D) Added.......................................85870 1.83 (a) revised...................................................85872 1.90 Revised.......................................................85872 1.94 (a) and (c) amended...........................................85873 1.227 Amended......................................................45949 1.230 Revised......................................................45950 1.231 Revised......................................................45950 1.232 Revised......................................................45951 1.233 Revised......................................................45952 1.234 Revised......................................................45952 1.235 Revised......................................................45952 1.241 Revised......................................................45953 1.245 Added........................................................45953 1.500 Amended......................................................25327 1.501 Heading revised..............................................25327 1.511 Heading, (a) heading and (b) heading revised.................25327 1.512 (b)(3)(ii) introductory text and (c)(1)(i) amended; (b)(3)(iii) and (iv) revised...................................25327 1.634 (a)(4)(iii) added............................................90193 1.664 (a)(4) added.................................................90193 1.700 Undesignated center heading and section added................90193 1.705 Added........................................................90193 1.710 Added........................................................90193 1.715 Added........................................................90193 1.720 Added........................................................90193 1.725 Added........................................................90193 1.900--1.934 (Subpart O) Added.....................................20166 2.125 (e)(4)(vi) and (ix) removed..................................74302 Regulation at 81 FR 74302 eff. date confirmed....................12067 4.100--4.105 (Subpart B) Added.....................................92624 5 Nomenclature change..............................................49895 5.1100 Revised.....................................................78033 10.20 (e) revised..................................................78505 [[Page 40]] 10.30 (b) introductory text revised; (c), (d), (e)(2), (ii) and (3) amended; (e)(2)(iii) redesignated as (e)(2)(iv); new (e)(2)(iii) and (5) added......................................78505 10.31 Added........................................................78506 10.35 (b) and (e) introductory text amended; (i) added.............78506 11 Policy statement.........................................54499, 57784 11.1 (n) added.....................................................20170 (o) added........................................................34218 Regulation at 79 FR 71253 compliance date extended to 5-5-17.....96364 14.1 (a)(2)(v) removed.............................................45409 14.100 (b)(5) redesignated as (b)(4); (b)(6) removed...............37153 16 Policy statement................................................57784 16.1 (b)(1) and (2) amended........................................52995 17.2 Revised.......................................................62358 20 Technical correction............................................89848 20.100 (c)(22) removed.............................................45409 (c)(46) added....................................................55046 (c)(9) amended...................................................60212 Regulation at 81 FR 55046 eff. date corrected....................62004 20.116 Revised.....................................................60212 25.20 (k) revised..................................................55047 Regulation at 81 FR 55047 eff. date corrected....................62004 25.32 (f), (i), (j), (k) and (r) revised...........................55047 Regulation at 81 FR 55047 eff. date corrected....................62004 56 Authority citation revised......................................19035 Regulation at 81 FR 19035 eff. date confirmed....................47288 56.120 (b)(4) and (c) redesignated as (c) and (d); (b) and new (c) revised........................................................19035 Regulation at 81 FR 19035 eff. date confirmed....................47288 70 Nomenclature change.............................................49895 71 Nomenclature change.............................................49895 73 Nomenclature change.............................................49895 73.3126 (b)(1) revised.............................................75692 Regulation at 81 FR 75692 eff. date confirmed.....................7648 74.3045 (c)(1) introductory text and (i) revised...................75692 Regulation at 81 FR 75692 eff. date confirmed.....................7648 80 Nomenclature change.............................................49895 100 Nomenclature change............................................49895 100.155 (a) and (b) amended........................................59131 101 Policy statement...................43061, 54499, 54501, 66527, 85156 Nomenclature change..............................................49895 101.2 (c) introductory text amended................................59131 101.7 Redesignated from 101.105; heading revised...................59131 101.8 Regulation at 79 FR 71291 compliance date extended in part to 7-26-18.....................................................50303 101.9 (c)(1)(ii), (j)(5)(ii)(C), (D), (E) and (13)(ii)(C) removed; (c)(1)(iii) and (j)(13)(ii)(D) redesignated as new (c)(1)(ii) and new (j)(13)(ii)(C); (c)(1)(i)(A) through (E), new (ii), (2), (5), (6)(i) through (4), (7), (8) introductory text, (i), (ii) introductory text, (iii), (iv), (v), (9), (d)(1) introductory text, (iii), (iv), (v), (2) through (5), (7) introductory text, (i), (8), (9), (11)(ii), (iii), (12), (13)(ii), (e), (f) introductory text, (2)(ii), (4), (5), (g) introductory text, (2), (3)(ii), (4), (5), (6), (8), (h)(3)(iv), (4) introductory text, (j)(5)(i), (ii) introductory text, (A), (B), (13)(i), (ii)(A)(1), (2), (B) and (18)(iv) introductory text revised; (c)(1)(i)(F), (8)(vii), (g)(10), (11), (j)(5)(iii) and (l) added.......................33979 (b)(2)(i)(D), (6), (8)(iii), (10)(ii) and (h)(3)(ii) revised; (b)(2)(i)(E) removed; (b)(2)(i)(F) through (I) redesignated as new (b)(2)(i)(E) through (H); (b)(12) added......................34040 (j)(1)(i), (2) introductory text and (3) introductory text revised; (j)(4) amended; eff. date note removed; CFR correction 84465 Regulation at 79 FR 71253 compliance date extended to 5-5-17.....96364 101.10 Revised; CFR correction.....................................84465 Regulation at 79 FR 71253 compliance date extended to 5-5-17.....96364 101.11 Added; CFR correction.......................................84459 Regulation at 79 FR 71253 compliance date extended to 5-5-17.....96364 [[Page 41]] 101.12 (f)(2) removed; (f)(3) redesignated as new (f)(2); (b) tables 1 and 2, (c), (f)(1) and new (2) revised................34041 101.13 (d)(2), (h)(4)(i) and (i)(2) amended........................59131 101.30 (e)(2) revised..............................................33994 (g) amended......................................................59131 101.36 (b)(2)(i) introductory text, (B), (ii)(A), (B), (iii) introductory text, (D) through (G), (3)(ii)(A), (c)(4), (e) introductory text, (8), (11)(i) through (viii), (12), (f) and (i)(1) revised; (i) introductory text removed..................33994 101.75 (c)(1) and (2)(ii) revised; interim.........................91722 101.105 Redesignated as 101.7......................................59131 102 Nomenclature change............................................49895 104.5 (b) amended..................................................59131 106 Policy statement........................................22174, 57784 Nomenclature change..............................................49895 107 Nomenclature change............................................49895 108 Nomenclature change............................................49896 108.25 (c)(1) and (2) revised......................................46831 108.35 (c)(1), (2) introductory text, (ii) and (i) revised.........46831 109 Nomenclature change............................................49896 110 Nomenclature change............................................49896 Policy statement.................................................57784 111 Policy statement...............................................57784 112 Nomenclature change............................................49896 Policy statement.................................................57784 112.3 (a), (b) and (c) introductory text removed; introductory text added; amended............................................26467 112.55 (b) revised.................................................26468 114 Policy statement...............................................57784 117 Nomenclature change............................................49896 Policy statement..........................................57784, 75692 117.3 Regulation at 80 FR 56145 eff. date confirmed in part........64060 118 Nomenclature change............................................49896 120 Policy statement...............................................57784 121 Added..........................................................34219 123 Policy statement...............................................57784 129 Policy statement...............................................57784 130 Nomenclature change............................................49896 161 Nomenclature change............................................49896 170 Nomenclature change............................................49896 170.3 (h) and (k) revised; (i) amended.............................55047 Regulation at 81 FR 55047 eff. date corrected....................62004 170.30 (a), (c)(1), (d), (h) introductory text, (1), (i), (j), (k) and (l) amended; (b), (c)(2) and (e) revised; (f) removed......55047 Regulation at 81 FR 55047 eff. date corrected....................62004 170.35 (a), (b)(1), (3) and (4) revised; (c) removed...............55048 Regulation at 81 FR 55048 eff. date corrected....................62004 170.38 (a) revised.................................................55048 Regulation at 81 FR 55048 eff. date corrected....................62004 170.203--170.285 (Subpart E) Added.................................55048 Regulation at 81 FR 55048 eff. date corrected....................62004 171 Nomenclature change............................................49896 172 Nomenclature change............................................49896 172.345 (b) amended; (i) added.....................................22183 172.379 (b) amended; (c) table revised.............................46581 172.380 (b) amended; (c)(8) added..................................46582 173 Nomenclature change............................................49896 175 Nomenclature change............................................49896 176 Nomenclature change............................................49896 176.170 (a)(5) table amended.......................................83674 177 Nomenclature change............................................49896 178 Nomenclature change............................................49896 179 Policy statement...............................................57784 180 Nomenclature change............................................49896 181 Nomenclature change............................................49896 184 Nomenclature change............................................49897 184.1 (a) and (b)(1) amended.......................................55051 Regulation at 81 FR 55051 eff. date corrected....................62004 186.1 (a) and (b)(1) amended.......................................55051 Regulation at 81 FR 55051 eff. date corrected....................62004 189 Nomenclature change............................................49897 190 Nomenclature change............................................49897 201 Technical correction...........................................89848 201.1 (f) amended..................................................60212 201.2 Amended......................................................60212 201.25 (c)(1) introductory text amended............................60212 201.128 Revised.....................................................2217 Regulation at 82 FR 2217 eff. date delayed to 3- 21-17...........................................................9501 201.161 Revised....................................................81696 201.328 Added......................................................81696 207 Revised........................................................60212 Technical correction.............................................89848 211 Nomenclature change............................................49897 Policy statement.................................................57784 [[Page 42]] 211.94 (e) added...................................................81697 211.125 (c) amended................................................81697 216 Heading and authority citation revised.........................69676 216.24 Revised.....................................................69676 310 Authority citation revised.....................................61129 310.545 (a)(27)(iii), (iv) and (d)(41) added; (d) introductory text amended...................................................61129 314 Authority citation revised.....................................69636 Technical correction.............................................89848 314.3 Revised......................................................69636 314.50 (a) introductory text, (5), (b), (c)(1), (2)(i), (iv) through (viii), (d) introductory text, (1)(i), (ii)(a), (iii), (iv), (v), (3)(ii), (5)(iv), (v), (vi)(a), (b), (e)(1)(i) introductory text, (2) introductory text, (f) introductory text, (1), (2), (3), (g)(2), (h), (j) introductory text, (3), (4) introductory text, (i), (ii), (iii), (k), (l) heading, (1) introductory text and (4) amended; heading, introductory text, (a)(1), (e)(1) introductory text, (f)(4), (g)(3), (i), (l)(2) and (3) revised................................................69639 314.52 Revised.....................................................69641 314.53 Revised.....................................................69643 314.54 (a)(1) introductory text, (i) and (3) amended; heading, (a) introductory text, (1)(iii), (v), (vi), (2), (4) and (b) revised........................................................69647 314.60 Amended; (b)(1), (4), (c)(1)(i) and (2) amended; (b) heading, (c) heading, (e) and (f) added; heading, (a), (c)(1)(iii) and (d) revised....................................69648 314.70 (a) heading, (1)(i), (ii), (6), (b)(2)(i), (viii), (4), (c)(6) introductory text, (7), (d)(2)(v), (vi), (vii), (3)(i) and (e) amended; heading, (a)(2) and (f) revised; (h) added....69648 314.81 (b)(3)(iv) revised..........................................60221 314.90 Amended; (c) added..........................................69649 314.93 (a), (b), (c), (d)(3), (e)(1)(iii)(C), (v) and (3) amended; (f) redesignated as (f)(1); (e)(1)(vi) and (f)(2) added........69649 314.94 (a) introductory text, (1), (5)(ii)(A), (6)(ii), (7)(i), (ii) introductory text, (C), (8)(i), (iv), (9)(ii) through (v), (12)(i)(A)(1) through (4), (13), (b), (d)(1)(i), (4) and (5) amended; (a)(12)(iv) removed; heading, introductory text, (a) heading, (2), (3), (7)(iii), (9)(i), (12)(i) heading, (A) introductory text, (4), (B), (ii) through (viii), (d) heading, (1) introductory text and (2) revised..........................69649 314.95 Revised.....................................................69651 314.96 Heading revised; (a) heading, (1) and (b) amended; (b) heading, (c) and (d) added.....................................69652 314.97 Revised.....................................................69653 314.99 Revised.....................................................69653 314.101 Revised....................................................69653 314.105 Revised....................................................69654 314.107 Revised....................................................69655 314.108 (a) introductory text, (b) heading and (2) through (5) revised; (a) amended...........................................69657 314.125 (b)(11) amended............................................60221 (a) introductory text, (2), (b)(2), (7), (9), (10), (11), (12) and (14) through (18) amended; heading and (b) introductory text revised; (b)(19) added...........................................69658 314.127 (a) introductory text, (3) through (7), (3)(iii)(A)(2), (8)(ii)(A) introductory text, (9), (10), (12) and (b) amended; heading, (a) introductory text, (2), (8)(i) introductory text, (ii)(B) and (C) revised; (a)(14) added.........................69658 320.1 Revised......................................................69658 320.23 (a)(1) and (2) amended; (b) redesignated as (b)(1); (b)(2) added..........................................................69658 330 Authority citation revised.....................................84475 330.14 (a) redesignated as introductory text; new introductory text, (f) heading, introductory text and (g)(4) revised; new (a), (j) and (k) added.........................................84475 330.15 Added.......................................................84477 507 Nomenclature change............................................49897 Policy statement..........................................57784, 75693 507.3 Regulation at 80 FR 56337 eff. date confirmed in part........64060 [[Page 43]] 510.600 (c)(1) table and (2) table amended....36788, 48702, 59133, 67151 (c)(1) table and (2) table amended...............................11508 514 Authority citation revised.....................................29141 Technical correction.............................................89848 514.80 (b)(4) introductory text amended; (b)(4)(i) revised.........29141 514.87 Added.......................................................29141 514.111 (a)(12) added..............................................60221 514.200 Revised....................................................52997 515 Technical correction...........................................89848 515.10 (b)(8) amended..............................................60221 520 Drug application approvals withdrawn...........................36790 520.88g (b) amended................................................11508 520.100 (b)(3) and (4) removed.....................................59133 520.110 (b) amended................................................48702 (d)(3) amended...................................................94989 520.284 Redesignated from 520.300..................................59133 520.284a Redesignated from 520.300a................................59133 520.284b Redesignated from 520.300b................................59133 520.284c Redesignated from 520.300c................................59133 520.292 Added......................................................59133 520.300 Redesignated as 520.284....................................59133 520.300a Redesignated as 520.284a..................................59133 520.300b Redesignated as 520.284b..................................59133 520.300c Redesignated as 520.284c..................................59133 520.441 (d)(1)(i)(A)(2), (2)(i)(A)(2), (4)(i)(A)(2), (B)(2), (ii)(A)(2), (B)(2), (iii)(C), (iv)(C), (5)(i)(A)(2), (ii)(A)(2), (iii)(C) and (iv)(C) amended.......................94989 520.445 (d)(3) amended.............................................94989 520.540c (b) amended...............................................11508 520.823 (d)(1)(i), (iii), (2)(i), (iii), (3)(i) and (iii) revised 94989 520.928 (c) revised................................................67151 520.1044a (d)(3) revised...........................................94989 520.1044c (d)(3) revised; (d)(4) removed...........................94989 520.1084 Added.....................................................36789 520.1263c (b)(1), (d)(1)(iii), (2)(iii) and (3)(iii) amended.......94989 520.1265 (d)(3) added..............................................94989 520.1430 Heading revised...........................................36789 520.1484 (e)(1)(iii) and (2)(iii) revised..........................94989 520.1660a Heading, (e)(1) and (3) revised..........................94989 520.1660d (d)(1)(i)(A)(1), (3), (B)(1), (3), (ii)(A)(1), (3), (B)(1), (3), (C)(1), (3), (iii)(A), (C), (iv)(A), (iv)(C), (v)(A), (v)(C), (2)(i) and (iii) revised.......................94989 520.1696b (b) amended..............................................36789 (c) redesignated as (d); new (c) added; new (d)(3) revised.......94990 520.2075 (a) and (c) revised.......................................59133 520.2123b (d)(1)(i) removed; (d)(1)(ii) and (iii) redesignated as new (d)(1)(i) and (ii); (d)(2) amended.........................94990 520.2130 (b) amended...............................................48702 520.2134 (b) amended...............................................48702 520.2184 (d)(3) amended............................................94990 520.2200 (d)(1)(iii) and (2)(iii) amended..........................94990 520.2218 (d)(1)(ii) and (2)(ii) amended............................94990 520.2220a Heading, (d)(1)(iii), (2)(iii) and (3)(iii) revised......94990 520.2261a (b) amended..............................................36789 (d)(3) amended...................................................94990 520.2261b (d)(1)(iii), (2)(iii), (3)(iii) and (4)(iii) amended.....94990 520.2325a (a)(2) removed; (a)(3) and (4) redesignated as new (a)(2) and (3).................................................36789 (a)(3) amended...................................................59134 (d) amended......................................................94990 520.2345c (d)(1)(iii) removed......................................67151 520.2345d (d)(1)(iii), (2)(iii), (3)(iii) and (4)(iii) amended.....94990 520.2471 (b) amended...............................................48702 520.2640 (b)(1) amended............................................48702 522.150 (b) amended................................................48702 522.224 Added......................................................67151 522.540 (d)(2)(i) amended..........................................11508 522.690 (b)(3) amended.............................................36789 522.840 (b) amended................................................48702 522.842 (a)(2) amended.............................................48702 522.1055 Revised...................................................59134 (b) amended......................................................11508 522.1077 (b)(3) amended............................................36789 522.1182 (b) introductory text, (7) introductory text, (i) and (ii) amended...................................................59134 (b)(3) amended...................................................11508 522.1192 (b)(2) amended............................................59134 522.1260 (b)(2) amended............................................59134 522.1380 (b) amended...............................................11508 522.1680 (b) amended...............................................36789 522.1684 Added.....................................................36789 [[Page 44]] (b) amended......................................................48702 522.1870 (a), (c)(1)(i), (iii), (2)(i) and (iii) revised...........67151 522.1940 (a)(2) amended............................................48702 522.2005 (b)(1) amended............................................36789 522.2112 (b) amended...............................................48702 522.2471 (b) amended...............................................48703 522.2476 (a)(1) amended............................................48703 522.2477 (b)(1) amended............................................48703 522.2615 (b) amended...............................................11508 522.2630 (d)(1)(iii)(A) revised....................................67151 522.2640 (b)(1) amended............................................48703 Revised..........................................................67151 524 Drug application approvals withdrawn...........................11509 524.916 (b) amended................................................48703 524.998 Added......................................................67152 524.1005 (b)(1) amended............................................11508 524.1044g (b)(3) correctly amended.................................18749 524.1044h (a) and (b) revised......................................59134 524.1193 (b)(2) correctly amended..................................25328 524.1445 (b) amended...............................................48703 524.1465 (b) amended...............................................11508 524.1484k Heading correctly revised................................25328 529.400 (a) footnote 1 removed.....................................67152 529.1660 (d)(3) added..............................................94991 556.480 Removed....................................................94994 556.748 (c) revised................................................36789 558 Drug application approvals withdrawn.............36790, 59135, 95025 Drug application approvals withdrawn.............................11509 558.3 (b)(1)(i) and (ii) revised; (b)(13) and (14) added...........57800 Regulation at 81 FR 57800 eff. date confirmed....................85873 558.4 (d) tables amended.............................36790, 59134, 94995 558.58 (e)(6) amended..............................................67152 (e)(2), (7), (8), (10) and (11) removed; (f) added...............94995 558.59 Revised..............................................67152, 94995 558.68 (b) amended.................................................48703 (a) and (e) revised..............................................59134 (c) and (d) redesignated as (d) and (c); (e)(1)(i) and (2)(i) amended..........................................................67152 (e)(1)(ii) revised...............................................11509 558.76 (e)(2)(iii) through (xvi) redesignated as (e)(2)(iv) through (xvii); new (e)(2)(iii) added..........................94995 558.128 (e)(7)(xi) amended.........................................67152 Revised..........................................................94995 558.140 (b)(2) amended.............................................63054 (d) redesignated as (e); new (d) added...........................95004 558.145 (a)(2) removed.............................................63054 Removed..........................................................95004 558.175 (b) amended; (c) and (e) added; (d)(5) and (6) removed.....95004 558.195 (e)(1)(vi), (2)(iii) and (v) amended.......................67152 (e)(1)(iv), (v), (vi), (2)(ii), (iv) and (vii) removed; (e)(4) added............................................................95004 558.198 (d)(1)(iv) and (v) removed; (d)(3) added...................95004 558.248 (a) and (b) revised; (d)(1)(iii) removed...................36790 (d) redesignated as (e); new (d) added; (a) and new (e) revised 95004 558.258 (e)(2)(ii) through (v) removed; (e)(6) added...............95005 558.261 (c) and (d) redesignated as (d) and (c)....................67152 558.265 (d)(1)(iii), (iv) and (vii) removed; (d)(4) added..........95005 558.274 (a)(1), (c)(1)(i), (ii), (2)(i) and (ii) amended...........48703 (c)(1)(ii) and (2)(ii) removed...................................59135 Revised..........................................................95005 558.295 (b) removed................................................67152 558.300 (e)(4) through (7) removed; (f) added......................95005 558.305 (e)(2), (3), (5) and (6) removed; (e)(4) redesignated as new (e)(2); (f) added..........................................95005 558.311 (e)(1)(i), (vi), (vii) and (xv) amended; (e)(1)(iii), (v) and (xx) through (xxviii) removed; (e)(5)(i) redesignated as (e)(5)(ii); new (e)(5)(i) and (iii) added......................95005 558.325 (d)(3) revised.............................................67152 Revised..........................................................95005 558.342 (b)(2), (e)(1)(i) through (iv), (ix) and (x) amended.......48703 (e)(1)(iv), (ix), (x) and (xi) amended...........................67152 (e)(1)(iii), (iv), (viii), (ix) and (xi) removed; (e)(2) revised 95009 558.355 (b)(1), (2), (4) through (9), (11), (12), (14), (f)(1)(xiii)(b), (xxi)(b), (xxii)(b), (xxviii)(b), (xxix)(b), (xxxi)(b), (3)(i)(b)(2)(iii), (ii)(b), (xii)(b), [[Page 45]] (4)(ii)(b), (iii)(b) and (6)(i)(b)(2)(iii) amended.............48703 (f)(1)(xxviii) removed; (f)(8)(i) and (ii) revised...............59135 (a) and (b) and (f)(8) revised; (f)(1)(viii), (ix), (xiii), (xiv), (xxi), (xxii), (xxxi), (2)(iv), (3)(ii) and (xii) removed 95009 558.363 (a)(1), (3), (8), (d)(1)(ii)(B), (iii)(B), (iv)(B), (v)(B) and (vi)(B) amended............................................48703 (d)(1)(vi) removed...............................................59135 558.364 (d) redesignated as (e); (a) through (d) revised...........95009 558.366 (b) and (d) amended........................................48703 (d) amended......................................................67153 (d) table amended; (e) added.....................................95009 558.435 Removed....................................................95009 558.450 Revised....................................................95009 (e)(4)(iii) redesignated as (e)(4)(v); new (e)(4)(iii) and (iv) added.....................................11512 558.455 (d) revised; (e)(1)(i), (2)(i), (3)(i), (4)(i), (ii) and (iv) removed; (e)(4)(v) amended................................95012 558.460 Removed....................................................95013 558.485 (e)(1)(v) through (xii) removed; (e)(3) added..............95013 558.500 (b), (e)(1)(i) through (iv), (2)(i) through (xiii) and (3)(i) through (iv) amended....................................48703 (e)(1)(ii), (iii), (iv), (2)(iv), (ix), (x) and (xiii) removed; (e)(4) added.....................................................95013 558.515 (d) table amended; (e) added...............................95013 558.550 (d)(1)(xxii)(B) amended....................................48703 (d)(1)(xxii) removed.............................................59135 (d)(1)(x), (xi), (xiii) and (xvi) removed; (d)(4) revised........95013 558.555 (d)(3), (4), (5), (e)(2), (3) and (4) removed; (f) added 95013 558.575 Heading and (a) revised; (b), (c) and (d) redesignated as (c), (d) and (e); new (b) and (d) added........................95013 558.582 Revised....................................................95013 558.586 Revised....................................................95013 558.612 (e)(1)(i) and (iii) removed; (e)(1)(ii) and (iv) redesignated as new (e)(1)(i) and (ii); (e)(2) added...........95015 558.618 (b), (e)(1)(i) and (2)(i) amended..........................48703 (e)(2)(ii) and (iii) amended.....................................59135 (c) and (d) redesignated as (d) and (c)..........................67153 558.625 (b)(3) removed; (b)(4) and (5) redesignated as new (b)(3) and (4)........................................................36790 (b)(1), (f)(2)(i), (iii) and (vii) revised; (f)(2)(viii) and (ix) removed.....................................................59135 (b)(1) amended...................................................48703 (d) removed; (c), (e) and (f) redesignated as (d), (c) and (e); (b), new (d) and new (e) revised.................................95015 558.630 (b)(1) amended.............................................48703 (b)(1) revised...................................................59135 Revised..........................................................95021 558.633 Added......................................................36790 (d)(1) revised...................................................67153 558.635 Revised....................................................95022 (a) and (e) revised; (d)(1) and (2) added........................11512 558.665 (e)(2) through (6), (8), (10), (11) and (12) amended.......48703 (e)(5), (6), (11) and (12) removed; (f) added....................95025 558.680 (d)(1)(x) removed; (e)(3) added............................95025 570.3 (f), (h) and (k) revised; (i) amended; (n) added.............55051 Regulation at 81 FR 55051 eff. date corrected....................62004 570.30 (a) and (i) amended; (b), (c) and (d) revised...............55052 Regulation at 81 FR 55052 eff. date corrected....................62004 570.35 (a), (b)(1), (3) and (4) revised; (c) removed...............55052 Regulation at 81 FR 55052 eff. date corrected....................62004 570.38 (a) revised.................................................55052 Regulation at 81 FR 55052 eff. date corrected....................62004 570.203--570.280 (Subpart E) Added.................................55052 Regulation at 81 FR 55052 eff. date corrected....................62004 573.304 Added......................................................35611 Regulation at 81 FR 35611 eff. date confirmed; comment period extended.........................................................41441 573.496 Added......................................................86269 573.696 Added......................................................67154 Introductory text and (b) revised................................95027 601 Technical correction...........................................89848 601.2 (f) added....................................................60221 [[Page 46]] 607 Heading revised................................................60221 Technical correction.............................................89848 607.1 Added........................................................60221 607.3 (b) amended; (k) and (l) added...............................60222 607.7 Revised......................................................60222 607.20 (c) amended.................................................60222 607.21 Amended.....................................................60222 607.22 Revised.....................................................60222 607.25 Revised.....................................................60222 607.26 Amended.....................................................60222 607.30 (a) introductory text revised...............................60222 607.35 Revised.....................................................60223 607.37 Revised.....................................................60223 607.39 Revised.....................................................60223 607.40 (d) introductory text and (3) revised; (e) added............60223 607.65 (g) added...................................................60223 607.80 (Subpart E) Added...........................................60223 610.20--610.21 (Subpart C) Removed.................................26691 Regulation at 81 FR 26691 eff. date confirmed....................52329 610.50 Revised.....................................................26691 Regulation at 81 FR 26691 eff. date confirmed....................52329 610.53 Revised.....................................................26691 Regulation at 81 FR 26691 eff. date confirmed....................52329 660.2 (c) revised..................................................38924 660.20 (a) revised.................................................38925 660.28 Revised.....................................................38925 660.35 Revised.....................................................38926 660.45 Revised.....................................................38928 660.50 (a) revised.................................................38928 660.55 Revised.....................................................38928 701 Nomenclature change............................................49897 710 Nomenclature change............................................49897 720 Nomenclature change............................................49897 801 Authority citation revised.....................................38930 801.4 Revised.......................................................2217 Regulation at 82 FR 2217 eff. date delayed to 3- 21-17...........................................................9501 801.15 Heading and (c)(1) revised..................................38930 801.109 (b)(1) revised.............................................38930 807.85 (a) introductory text revised...............................70340 809.10 (a)(4) and (b)(5)(ii) amended; (g) added....................38931 812.3 (b) revised..................................................70340 862 Actions on petitions....................................68293, 68295 866.3328 Added......................................................3618 870.4510 Added.....................................................71371 870.5200 Revised...................................................33133 870.5210 Added.....................................................33134 870.5800 Reinstated; CFR correction.................................4151 874.4180 Added.....................................................73029 876.5011 Added.....................................................45231 878.4420 Added.....................................................42244 878.4460 Heading and (a) revised...................................91730 878.4480 Removed...................................................91730 878.4815 Added.....................................................64763 880.5140 Revised...................................................91737 880.5145 Added.....................................................91737 880.6250 Heading and (a) revised...................................91730 882 Authority citation revised.....................................87811 882.1471 Added.....................................................87811 882.1561 Added.....................................................67155 882.5600 Added.....................................................94253 882.5700 Added.....................................................44772 884.4050 Added.....................................................40183 884.4910 Added......................................................1603 886.1342 Added.....................................................65280 886.1925 Added.....................................................34270 886.5838 Added.....................................................37500 888 Technical correction............................................2217 888.3070 Heading, (a) and (b)(2) revised; (b)(3) added; (c) removed........................................................96373 890 Authority citation revised.....................................71612 890.3450 Added.....................................................71612 890.5525 (b) revised; (c) removed..................................48706 895.102 Added......................................................91731 895.103 Added......................................................91731 1005.2 Revised.....................................................85873 1100 Added.........................................................29102 Authority citation revised........................................2217 Regulation at 82 FR 2217 eff. date delayed to 3- 21-17...........................................................9501 1100.5 Added........................................................2217 Regulation at 82 FR 2217 eff. date delayed to 3- 21-17...........................................................9501 1105 Added..................................................52334, 95868 Regulation at 81 FR 52334 withdrawn..............................80567 Regulation at 81 FR 95868 eff. date delayed to 3-21-17.........................................................8894 1140 Heading revised...............................................29102 1140.1 Revised.....................................................29102 1140.2 Revised.....................................................29102 1140.3 Revised.....................................................29102 1140.10 Revised....................................................29103 1140.14 Revised....................................................29103 1143 Added.........................................................29103 1150 Authority citation revised....................................28715 [[Page 47]] 1150.3 Amended.....................................................28715 1150.5 (a) amended; (c) and (d) added..............................28715 1150.7 (a)(1) revised; (a)(2) added................................28716 1150.9 (a)(1) revised; (a)(2) added................................28716 1250 Nomenclature change...........................................49897 1271 Technical correction..........................................89848 1271.1 (a) and (b)(2) amended......................................60223 1271.3 (mm) and (nn) added.........................................60223 1271.20 Amended....................................................60223 1271.22 Revised....................................................60223 1271.23 Added......................................................60224 1271.25 (a) introductory text, (2), (3) and (c)(4) revised; (a)(5), (6) and (d) added......................................60224 1271.26 Revised....................................................60224 1271.90 (b) redesignated as (c); new (b) added; heading, (a)(3) introductory text, (4), new (c) introductory text, (2) and (6) revised........................................................40517 1271.370 (b)(4) amended............................................40518 1271.420 (a) revised...............................................85873 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1300.01 (b) amended................................................97018 Regulation at 81 FR 97018 eff. date delayed to 3-21-17.........................................................8688 1300.02 (b) amended................................................97019 Regulation at 81 FR 97019 eff. date delayed to 3-21-17.........................................................8688 1301 Policy statement..............................................53846 1301.12 (b)(3) revised.............................................97019 Regulation at 81 FR 97019 eff. date delayed to 3-21-17.........................................................8688 1301.24 (a)(1) revised.............................................97019 Regulation at 81 FR 97019 eff. date delayed to 3-21-17.........................................................8688 1301.26 (b) introductory text revised..............................97019 Regulation at 81 FR 97019 eff. date delayed to 3-21-17.........................................................8688 1301.34 (c)(2) revised.............................................97019 Regulation at 81 FR 97019 eff. date delayed to 3-21-17.........................................................8688 1301.74 (g) revised; interim.......................................58839 (c) introductory text revised....................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1301.75 (e) revised; interim.......................................58839 1302.07 Revised....................................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1303.12 (b) and (d) amended........................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1303.22 Introductory text amended..................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1304.02 Revised....................................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1304.21 (d) revised................................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1304.31 (a) amended................................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1304.32 (a) amended................................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1304.33 (a) and (f)(1) revised.....................................97020 Regulation at 81 FR 97020 eff. date delayed to 3-21-17.........................................................8688 1305.07 Introductory text and (a) revised; interim.................58839 1305.17 (d) revised; interim.......................................58839 1308 Authority citation revised....................................97021 Policy statement..................................................8590 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1308.01 Revised....................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1308.11 (b)(3) through (55) redesignated as (b)(4) through (56); new (b)(3) added...............................................22025 (d)(48), (49) and (50) added; (h)(1), (2) and (3) removed; (h)(4) through (25) redesignated as new (h)(1) through (22)......29145 (h)(26) and (27) added...........................................29496 (d)(51) through (54) added; (h)(4) through (7) removed; (h)(8) through (22), (26) and (27) redesignated as new (h)(4) through (18), (19) and (20)..............................................61133 (d)(55), (56) and (57) added; (h)(1), (2) and (3) removed; (h)(4) through (20) redesignated as new (h)(1) through (17)......66184 (h)(18) added....................................................79393 [[Page 48]] (h)(19) added....................................................85877 (d)(58) added....................................................90196 (h)(23) through (28) added.......................................93599 (h)(23) through (28) correctly removed............................2218 1308.12 (c)(29) added; interim.....................................58839 1308.15 (e)(1), (2) and (3) redesignated as (e)(2), (3) and (4); new (e)(1) added; interim......................................29491 1308.21 (a) amended................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1308.23 (b) amended................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1308.25 (a) amended................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1308.31 (a) amended................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1308.33 (b) amended................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1308.49 Revised....................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1309.26 (a)(1) revised.............................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1309.32 (d) revised................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1309.46 (d) amended................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1309.51 (a) amended................................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1309.71 (b)(5) and (7) revised.....................................97021 Regulation at 81 FR 97021 eff. date delayed to 3-21-17.........................................................8688 1310 Heading revised...............................................97022 Regulation at 81 FR 97022 eff. date delayed to 3-21-17.........................................................8688 1310.03 (b) amended; (c) revised...................................97022 Regulation at 81 FR 97022 eff. date delayed to 3-21-17.........................................................8688 1310.05 (a) through (e) revised....................................97022 Regulation at 81 FR 97022 eff. date delayed to 3-21-17.........................................................8688 1310.06 Revised....................................................97023 Regulation at 81 FR 97023 eff. date delayed to 3-21-17.........................................................8688 1310.13 (b) amended................................................97025 Regulation at 81 FR 97025 eff. date delayed to 3-21-17.........................................................8688 1312.03 Added......................................................97025 Regulation at 81 FR 97025 eff. date delayed to 3-21-17.........................................................8688 1312.11 Revised....................................................97026 Regulation at 81 FR 97026 eff. date delayed to 3-21-17.........................................................8688 1312.12 Revised....................................................97026 Regulation at 81 FR 97026 eff. date delayed to 3-21-17.........................................................8688 1312.13 (e) revised................................................97027 Regulation at 81 FR 97027 eff. date delayed to 3-21-17.........................................................8688 1312.14 Revised....................................................97027 Regulation at 81 FR 97027 eff. date delayed to 3-21-17.........................................................8688 1312.15 (a) and (b) amended........................................97027 Regulation at 81 FR 97027 eff. date delayed to 3-21-17.........................................................8688 1312.16 Revised....................................................97027 Regulation at 81 FR 97027 eff. date delayed to 3-21-17.........................................................8688 1312.18 Heading, (b), (c) introductory text and (3) revised; (e) through (h) added..............................................97028 Regulation at 81 FR 97028 eff. date delayed to 3-21-17.........................................................8688 1312.19 Revised....................................................97029 Regulation at 81 FR 97029 eff. date delayed to 3-21-17.........................................................8688 1312.21 Revised....................................................97029 Regulation at 81 FR 97029 eff. date delayed to 3-21-17.........................................................8688 1312.22 Revised....................................................97029 Regulation at 81 FR 97029 eff. date delayed to 3-21-17.........................................................8688 1312.23 (e) revised................................................97032 Regulation at 81 FR 97032 eff. date delayed to 3-21-17.........................................................8688 1312.24 Revised....................................................97032 Regulation at 81 FR 97032 eff. date delayed to 3-21-17.........................................................8688 1312.25 Revised....................................................97032 Regulation at 81 FR 97032 eff. date delayed to 3-21-17.........................................................8688 1312.26 Revised....................................................97033 Regulation at 81 FR 97033 eff. date delayed to 3-21-17.........................................................8688 1312.27 Heading, (a) and (b) revised; (d) through (g) added........97033 Regulation at 81 FR 97033 eff. date delayed to 3-21-17.........................................................8688 1312.28 Revised....................................................97035 [[Page 49]] Regulation at 81 FR 97035 eff. date delayed to 3-21-17.........................................................8688 1312.31 (b) introductory text revised; (d)(2) and (3) amended; (d)(4) added...................................................97035 Regulation at 81 FR 97035 eff. date delayed to 3-21-17.........................................................8688 1312.32 Revised....................................................97036 Regulation at 81 FR 97036 eff. date delayed to 3-21-17.........................................................8688 1313.03 Added......................................................97036 Regulation at 81 FR 97036 eff. date delayed to 3-21-17.........................................................8688 1313.12 Heading, (a), (b), (c) introductory text, (d) and (e) introductory text revised......................................97036 Regulation at 81 FR 97036 eff. date delayed to 3-21-17.........................................................8688 1313.13 Revised....................................................97036 Regulation at 81 FR 97036 eff. date delayed to 3-21-17.........................................................8688 1313.14 Revised....................................................97037 Regulation at 81 FR 97037 eff. date delayed to 3-21-17.........................................................8688 1313.15 Heading and (b) revised....................................97037 Regulation at 81 FR 97037 eff. date delayed to 3-21-17.........................................................8688 1313.16 Heading and (b) revised....................................97037 Regulation at 81 FR 97037 eff. date delayed to 3-21-17.........................................................8688 1313.17 Revised....................................................97037 Regulation at 81 FR 97037 eff. date delayed to 3-21-17.........................................................8688 1313.21 Heading, (a), (b), (c) introductory text, (d) and (e) introductory text revised; (h) added...........................97038 Regulation at 81 FR 97038 eff. date delayed to 3-21-17.........................................................8688 1313.22 Revised....................................................97038 Regulation at 81 FR 97038 eff. date delayed to 3-21-17.........................................................8688 1313.23 Revised....................................................97038 Regulation at 81 FR 97038 eff. date delayed to 3-21-17.........................................................8688 1313.26 Heading and (b) revised....................................97039 Regulation at 81 FR 97039 eff. date delayed to 3-21-17.........................................................8688 1313.27 Revised....................................................97039 Regulation at 81 FR 97039 eff. date delayed to 3-21-17.........................................................8688 1313.31 (b) introductory text, (7), (8), (14) and (15) revised.....97039 Regulation at 81 FR 97039 eff. date delayed to 3-21-17.........................................................8688 1313.32 Revised....................................................97039 Regulation at 81 FR 97039 eff. date delayed to 3-21-17.........................................................8688 1313.33 (b) and (c) revised........................................97040 Regulation at 81 FR 97040 eff. date delayed to 3-21-17.........................................................8688 1313.34 Revised....................................................97040 Regulation at 81 FR 97040 eff. date delayed to 3-21-17.........................................................8688 1313.35 Revised....................................................97040 Regulation at 81 FR 97040 eff. date delayed to 3-21-17.........................................................8688 1314.110 (a)(1) and (2) amended....................................97040 Regulation at 81 FR 97040 eff. date delayed to 3-21-17.........................................................8688 1315 Nomenclature change...........................................97041 Regulation at 81 FR 97041 eff. date delayed to 3-21-17.........................................................8688 1316.47 (a) revised................................................97041 Regulation at 81 FR 97041 eff. date delayed to 3-21-17.........................................................8688 1316.48 Revised....................................................97041 Regulation at 81 FR 97041 eff. date delayed to 3-21-17.........................................................8688 1321.01 Revised....................................................97041 Regulation at 81 FR 97041 eff. date delayed to 3-21-17.........................................................8688 Proposed Rules: 1--1299 (Ch. I)....................................................79400 1......................................28035, 43155, 75349, 78526, 95068 2...........................................................74364, 74368 11..........................................................27067, 28035 ..................................................................7751 15.................................................................60299 ..................................................................6367 16............................................28035, 57812, 58342, 75351 ..................................................................7751 56.................................................................19066 58..........................................................58342, 75351 73...................................................63728, 69740, 90267 101....................................27067, 66562, 76323, 84516, 96404 ...........................................................4225, 10868 111................................................................28035 112................................................................75349 ..................................................................7751 117...........................................30219, 57816, 58421, 75349 ..................................................................4803 172................................................................38984 175..................................................31877, 37561, 52370 176...........................................25625, 31877, 37561, 52370 177...........................................31877, 37561, 42585, 52370 178..................................................31877, 37561, 52370 216.........................................................71648, 91071 310................................................................42912 330................................................................19069 507..................................................30219, 58421, 75349 [[Page 50]] 511................................................................57812 514................................................................74962 556................................................................74962 558................................................................57818 573..................................................67260, 78528, 96405 610................................................................26753 807................................................................71415 820................................................................24041 882.........................................................24386, 32258 895.........................................................24386, 32258 1005...............................................................43155 1100.................................................28778, 28780, 28781 1105...............................................................52371 1132................................................................8004 1140.................................................28778, 28780, 28781 1143.................................................28778, 28780, 28781 1150...............................................................28783 1271.................................................23661, 23664, 43155 1300--1399 (Ch. II).........................................53688, 53767 1300...............................................................63576 1301...............................................................63576 1302...............................................................63576 1303...............................................................63576 1304...............................................................63576 1308...................................59929, 61636, 63576, 66224, 70652 ............................................................2280, 8593 1309...............................................................63576 1310........................................................63576, 89402 1312...............................................................63576 1313...............................................................63576 1314...............................................................63576 1315...............................................................63576 1316...............................................................63576 1321...............................................................63576