[List of CFR Sections Affected (LSA), September 2018] [From the U.S. Government Publishing Office, www.gpo.gov] TITLE 21_FOOD AND DRUGS Chapter I_Food and Drug Administration, Department of Health and Human Services (Parts 1_1299) 1 Notification.....................................................22193 1 Policy statement.................................................42024 11 Notification.............................................20731, 22193 16 Notification....................................................22193 74.3054 Added......................................................26359 74.3054 Regulation at 83 FR 26359 eff. 7-10-18.....................47069 74.3708 Added......................................................48375 101 Policy statement...............................................19619 101 Notification............................................20731, 27894 102.50 Table revised...............................................19431 106 Notification...................................................22193 110 Notification...................................................22193 110 Regulation at 80 FR 56144 withdrawn............................46107 111 Notification...................................................22193 112 Notification...................................................22193 114 Notification...................................................22193 [[Page 44]] 117 Notification............................................22193, 46878 120 Notification...................................................22193 123 Notification...................................................22193 129 Notification...................................................22193 172 Notification...................................................23358 172.380 (b), (c)(1), and (2) revised...............................47559 179 Notification...................................................22193 211 Notification...................................................22193 507 Notification............................................22193, 46878 510.600 (c)(1) table and (2) table amended..................14586, 48943 514 Notification...................................................30534 520 Drug application approvals withdrawn...........................48950 520.390a (b)(1)(i) amended.........................................48944 520.441 (b)(3) amended.............................................48944 520.443 (b) amended................................................48944 520.580 (b)(1) and (2) amended.....................................48944 520.596 Redesignated from 520.600; new 520.596 revised........................................................48944 520.598 Added......................................................48945 520.600 Redesignated as 520.596....................................48944 520.600 Added......................................................48945 520.602 Added......................................................48945 520.622a (a)(6) amended............................................48945 520.622b (c)(2) amended............................................48945 520.622c (b)(6) amended............................................48945 520.763a (b) amended...............................................48945 520.763b (b) amended...............................................48945 520.763c (b) amended...............................................48945 520.905d (a) and (b) revised.......................................48945 520.1044c (b)(2) amended...........................................48945 520.1084 (b) amended...............................................14587 520.1182 Removed...................................................48945 520.1199 (a) introductory text and (c)(2) amended 14587 520.1242a (b)(3) amended...........................................48945 520.1263c (b)(1) and (2) amended...................................48945 520.1265 (b)(2) amended............................................48945 520.1286 Added.....................................................48945 520.1408 (b)(1) amended............................................48946 520.1660d (b)(4) amended...........................................48946 520.1720a (b)(2) amended...........................................48946 520.1804 Removed...................................................48946 520.1840 (b)(2) and (d)(4) removed; (b)(3) and (4) redesignated as new (b)(2) and new (3).........................48946 520.1900 (b)(1) amended............................................48946 520.2220a (b)(1) and (2) amended...................................48946 520.2345d (b)(4) amended...........................................48946 520.2380a (b)(1) and (d)(1)(i) removed.............................48946 520.2640 (b)(1) and (2) revised....................................14587 522 Drug application approvals withdrawn...........................48950 522.970 (b)(1) amended.............................................48946 522.1044 (b)(3) amended............................................48946 522.1182 (b)(4) amended............................................48946 522.1222 (b) amended...............................................48946 522.1242 (b) amended...............................................48946 522.1410 (b) amended...............................................48946 522.1660a (b) amended..............................................48946 522.1662a (a)(2), (b)(2), (g)(2), and (h)(2) amended........................................................48946 522.1720 (b)(3) amended............................................48946 522.2220 (b)(1) and (3) amended....................................48946 522.2424 (b) amended...............................................48946 522.2470 (b) and (c) revised.......................................14587 522.2483 (b) amended...............................................48946 522.2662 (b)(1) amended............................................48946 524 Drug application approvals withdrawn...........................48950 524.814 (b) revised................................................48946 524.815 Added......................................................48946 524.900 (b) amended................................................48946 524.1580a (b)(1) amended...........................................48947 524.1580b (b) amended..............................................48947 526.1696b (b) amended..............................................14587 529.1044a (b) amended..............................................48947 556.275 (b)(3)(ii) added...........................................48947 556.440 Removed....................................................48947 558 Drug application approvals withdrawn...........................48950 558.4 (d) table amended............................................48947 558.68 (e)(1)(iii) and (iv) added..................................14587 558.128 (e)(4)(ii), (vii), (viii), (ix), and (xviii) through (xxvi) amended.................................14588 558.128 (e)(4)(xi) and (xiii) amended..............................48947 558.185 (b) revised; (e)(1) removed; (e)(2) and (3) redesignated as new (e)(1) and (2).........................48947 558.195 (e)(2)(v) removed..........................................48947 558.205 (a) revised; (b), (c), and (d) redesignated as (c), (d), and (e); new (b) added..........................................................48947 558.311 (b)(9) and (e)(1)(xix) amended.............................14588 558.311 (e)(5) revised.............................................48947 558.325 (e)(2)(xiv) revised........................................14588 558.325 (e)(1)(ii) redesignated as (e)(1)(v); (e)(1)(iv), (vii), (viii), (ix), and (x) added 48947 558.342 (e)(1) tables amended; (e)(1)(v) through (xi) removed; (e)(2)(i), (ii), and (iii) redesignated as (e)(2)(ii), [[Page 45]] (iii), and (iv); (e)(1)(iii), (iv), and new (e)(2)(i) added................................................48948 558.365 Removed....................................................48948 558.450 (e)(5)(iv) amended.........................................48948 558.485 Revised....................................................48948 558.625 (e)(2)(ii) and (iii) revised...............................48949 573.615 Added......................................................19935 600.21 Regulation at 83 FR 3589 withdrawn..........................19936 600.22 Regulation at 83 FR 3589 withdrawn..........................19936 803 Notification...................................................40973 862.1840 (b) introductory text revised.............................25914 864.9165 Added.....................................................23217 866.5830 Added.....................................................27701 866.5950 (b) introductory text revised.............................25914 866.6080 Added.....................................................28995 876.1500 (b)(1) revised............................................25914 876.4310 Added.....................................................27703 876.4350 Added.....................................................27897 878.4040 (b)(1) revised............................................22848 878.4430 Added.....................................................26577 880.6210 Added.....................................................19628 880.6710 (b) revised...............................................25915 884.5330 Heading and (a) revised...................................48714 884.5340 Added.....................................................48714 884.5960 (b) revised...............................................25915 888 Authority citation revised.....................................26579 888.3023 Added.....................................................26579 890.5525 (b)(2)(i)(A) revised......................................13864 900.3 (b)(1) revised...............................................13864 900.11 (b)(2)(i) revised...........................................13864 1020.30 (c) revised................................................13864 1040.10 (a)(3)(i), (f)(6)(ii), and (g)(10) revised 13864 1040.20 (d)(3)(iii) and (iv) revised...............................13865 1308.15 (f) added..................................................48953 1312 Authority citation revised....................................48953 1312.30 Introductory text revised; (b) added.......................48953 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1303.11 (b)(4) amended; (b)(5) redesignated as (b)(7); new (b)(5) and (6) added; (c) revised 32789 1303.12 (b) amended................................................32790 1303.13 (b)(1) and (c) revised.....................................32790 1303.21 (a) amended................................................32790 1303.22 (c)(2) amended; (d) added..................................32790 1303.23 (a)(2) and (b)(2) amended..................................32790 1303.32 (a) amended................................................32790 1308 Policy statement..............................................21834 1308.11 (b)(18) through (58) redesignated as (b)(19) through (59); new (b)(18) and (60) added; (h)(2) and (4) removed..................................17488 1308.11 (h)(31) through (35) added (temporary).....................31882 1308.11 (h)(36) added (temporary)..................................44478 Proposed Rules: 1--1299 (Ch. I)....................................................49023 1...........................................................42062, 49022 3...........................................................22428, 26392 15...................................................30595, 35154, 38666 20.................................................................46437 73.................................................................15089 101.........................................................17961, 32221 172.........................................................23382, 47118 201................................................................22224 310................................................................46121 343................................................................22224 573................................................................34076 720................................................................46437 807................................................................46444 812................................................................46444 814................................................................46444 876................................................................41023 878................................................................41023 886.........................................................41023, 48403 892................................................................25598 1100........................................................26617, 26618 1130...............................................................26619 1140........................................................26617, 26618 1143........................................................26617, 26618 1303...............................................................17329 1308.................................................21826, 24696, 27520