[List of CFR Sections Affected (LSA), November 2003] [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....................................03-58960 Meeting.......................................................03-61340 Technical correction..........................................03-63017 1.225--1.243 (Subpart H) Added; interim.........................03-58960 1.276--1.285 (Subpart I) Added; interim.........................03-59070 3 Nomenclature change...........................................03-24879 3.1 Amended.....................................................03-37077 3.2 (b) revised.................................................03-37077 3.6 Revised.....................................................03-37077 3.7 (d) amended.................................................03-37077 3.9 (b) amended.................................................03-37077 [[Page 73]] 7 Nomenclature change...........................................03-24879 10 Nomenclature change..........................................03-24879 10.20 (c)(6) and (j)(2)(ii) amended.............................03-25285 12 Nomenclature change..........................................03-24879 14.61 (d) amended...............................................03-25285 16.1 (b)(2) amended; interim....................................03-62368 17 Nomenclature change..........................................03-24879 20 Meeting......................................................03-61340 Technical correction..........................................03-63017 20.20 (e) added.................................................03-25285 20.22 Existing text designated as (a); (b) added 03-25285 20.26 (a)(4) added; (b) revised.................................03-25285 20.27 Amended...................................................03-25285 20.28 Amended...................................................03-25285 20.29 Amended...................................................03-25285 20.33 Added.....................................................03-25285 20.34 Added.....................................................03-25285 20.40 (a) revised...............................................03-25285 20.41 (b) introductory text and (3) revised; (b)(2) amended; (c) added...................................03-25285 20.42 Redesignated as 20.45; new 20.42 added....................03-25286 20.43 Redesignated as 20.46; new 20.43 added....................03-25286 20.44 Revised...................................................03-25286 20.45 Redesignated as 20.47; new 20.45 redesignated from 20.42; (a) introductory text and (c)(1) amended; (c) introductory text and (6) revised.................................................03-25286 20.46 Redesignated as 20.48; new 20.46 redesignated from 20.43.....................................03-25286 (a) introductory text revised.................................03-25287 20.47 Redesignated as 20.49; new 20.47 redesignated from 20.45.....................................03-25286 20.48 Redesignated as 20.50; new 20.48 redesignated from 20.46.....................................03-25286 Amended.......................................................03-25287 20.49 Redesignated as 20.51; new 20.49 redesignated from 20.47.....................................03-25286 (a) and (c) revised...........................................03-25287 20.50 Redesignated as 20.52; new 20.50 redesignated from 20.48.....................................03-25286 20.51 Redesignated as 20.53; new 20.51 redesignated from 20.49.....................................03-25286 20.52 Redesignated as 20.54; new 20.52 redesignated from 20.50.....................................03-25286 20.53 Redesignated as 20.55; new 20.53 redesignated from 20.51.....................................03-25286 Amended.......................................................03-25287 20.54 Redesignated from 20.52...................................03-25286 20.55 Redesignated from 20.53...................................03-25286 20.81 (b) removed; (c) redesignated as new (b)..................03-25287 20.83 (a) amended...............................................03-25287 20.100 (c)(42) added; interim...................................03-58965 20.107 (a) revised..............................................03-25287 20.111 (b) and (c)(4) amended...................................03-25287 20.120 Added....................................................03-25287 (a) corrected.................................................03-65392 25 Nomenclature change..........................................03-24879 60 Nomenclature change..........................................03-24879 100 Nomenclature change.........................................03-24879 101 Nomenclature change.........................................03-24879 101.4 (h) revised...............................................03-51704 101.9 (c)(2)(ii) and (iii) redesignated as (c)(2)(iii) and (iv); new (c)(2)(ii) added; (c)(2)(i) and (d)(1)(ii)(A), (11)(iii) illustration, (12) illustration, (13)(ii) illustration, (e)(5) illustration, (j)(13)(ii)(A)(1) illustration and (2) illustration revised; (f), (g)(5) and (6) amended; eff. 1-1-06........................................03-41502 101.36 (b)(2)(i) revised; eff. 1-1-06...........................03-41505 101.80 Regulation at 67 FR 71461 confirmed......................03-39833 101.81 Regulation at 67 FR 61782 confirmed......................03-44209 101 Appendix B amended; eff. 1-1-06.............................03-41506 109 Nomenclature change.........................................03-24879 111 Removed.....................................................03-59715 165.110 Regulation at 68 FR 9881 confirmed.......................03-9881 172 Hearing denied..............................................03-46403 Technical correction................................03-57799, 03-57957 172.615 (a) table corrected; CFR correction.....................03-17277 172.867 (e) revised.............................................03-46402 172.869 Added...................................................03-50072 184 Nomenclature change.........................................03-24879 201 Nomenclature change.........................................03-24879 201.122 Corrected; CFR correction...............................03-55822 201.314 (h)(1) and (4) revised..................................03-18869 [[Page 74]] 201.323 Regulation at 65 FR 4110 eff. date delayed; (c) introductory text revised; (c)(3) amended; (d) and (e) redesignated as (e) and (f); new (d) added; eff. 7-26-04............................03-32981 310.518 Revised.................................................03-59715 310.538 (a) amended; (e) added..................................03-24348 310.545 (a)(3)(i) heading, (ii) and (d)(17) added; (d)(1) revised; eff. 4-19-04................................03-18881 (a)(18)(i), (v), (vi), and (d)(1) revised; (d)(32) added...............................................03-33376 (a)(4) redesignated as (a)(4)(i); new (a)(4)(i) heading, (ii) and (d)(34) added; (d)(1) revised.....................................................03-34291 (a)(26)(xi) and (d)(37) added; (d) introductory text and (13) revised.......................................03-51170 310.548 (d)(1) corrected........................................03-37963 312 Nomenclature change.........................................03-24879 314 Nomenclature change.........................................03-24879 314.52 (a)(3) redesignated as (a)(4); new (a)(3) added.......................................................03-36703 314.53 (b), (c)(1), (2) and (3) revised.........................03-36703 314.65 Amended..................................................03-25287 314.72 (a)(2)(iii) amended......................................03-25287 314.95 (a)(3) redesignated as (a)(4); new (a)(3) added.......................................................03-36705 328 Nomenclature change.........................................03-24879 330 Nomenclature change.........................................03-24879 335 Added; eff. 4-19-04.........................................03-18881 341.40 Corrected; eff. 12-23-04.................................03-17881 341.70 (b) corrected; eff. 12-23-04.............................03-17881 347.1--347.50 (Subpart A) Heading revised.......................03-33376 347.3 Revised...................................................03-33376 347.10--347.20 (Subpart B) Designation and heading added.......................................................03-33377 347.10 Redesignated as 347.12; new 347.10 added.................03-33377 347.12 Redesignated from 347.10.................................03-33377 347.20 Added; (d) suspended.....................................03-33377 347.50--347.60 (Subpart C) Designation and heading added.......................................................03-33377 347.50 Redesignated as 347.52; new 347.50 added.................03-33377 347.52 Redesignated from 347.50.................................03-33377 (c)(4) and (e) added; (d)(1)(i), (ii) and (3) revised.....................................................03-35293 Regulation at 68 FR 35293 confirmed...........................03-58273 347.60 Added....................................................03-33377 349.12 (a)(3) amended...........................................03-32982 350 Added.......................................................03-34291 352 Regulation at 66 FR 67485 reinstated........................03-33380 Suspended.....................................................03-33381 352.20 (b) added................................................03-33380 352.52 (c)(2) heading, (d)(4) heading, (f)(1)(ii) and (vi) revised............................................03-33380 352.60 (b)(2), (c) and (d) revised..............................03-33380 355 Nomenclature change.........................................03-24879 358.301--358.350 (Subpart D) Added..............................03-24348 369.20 Amended; eff. 4-19-04....................................03-18882 Amended.......................................................03-34293 500 Nomenclature change.........................................03-24879 509 Nomenclature change.........................................03-24879 510 Technical correction........................................03-42250 510.600 (c)(1) table and (2) table amended...........03-17882, 03-26995, 03-33381, 03-34293, 03-41066, 03-49704, 03-55823, 03-55824, 03- 59881, 03-62006 520 Nomenclature change.........................................03-24879 520.48 (c) and (d) revised......................................03-62006 520.88b (c) amended...................................03-54658, 03-55824 520.88f (b) amended...................................03-54658, 03-55824 520.446 (b)(3) amended..........................................03-55824 520.447 (b)(2) amended..........................................03-55824 520.522 Added...................................................03-54804 520.538 (d)(1) and (2) revised..................................03-18882 520.870 (a) amended.............................................03-51705 520.905a (d)(4)(ii) revised; (d)(4)(iii) amended 03-26205 520.1192 (a) and (b) revised; (d) redesignated as (e); new (d) added; new (e)(1)(iii) and (2)(iii) amended; new (e)(1)(ii) redesignated as (e)(1)(ii)(B); new (e)(1)(ii)(A) added; new (e)(1)(ii)(B) amended.......................................03-43294 520.1196 (b) revised............................................03-55823 520.1198 Added..................................................03-38601 Revised.......................................................03-55309 520.1288 Revised................................................03-51905 520.1350 Added..................................................03-42968 520.1446 Heading, (a), (d)(1)(i), (ii) and (iii) revised.....................................................03-51905 520.1452 (a) and (d)(3) revised; (c) added......................03-51445 520.1453 Added..................................................03-51446 520.1510 Revised................................................03-51906 [[Page 75]] 520.1660d (a)(9) added..........................................03-42968 520.1696b (b) amended...........................................03-26204 520.1720a (b)(5) added..........................................03-41066 (b)(3) amended................................................03-59881 520.1720c (a) and (b) revised; (c) removed; (d) redesignated as new (c).....................................03-43926 520.1870 (a), (b) and (c)(1) revised............................03-57351 520.1872 (a)(3) added; (c)(1)(i) table amended..................03-22293 520.2043 (b)(1) amended.........................................03-54803 (d)(1)(ii) revised............................................03-55199 (b)(2) and (d)(2)(i)(B) amended...............................03-55825 520.2044 (a)(3) and (b)(3) added................................03-34533 520.2340 Added..................................................03-34795 522 Nomenclature change.........................................03-24879 522.23 (b) introductory text amended............................03-33856 522.246 (b)(1) amended..........................................03-22594 522.312 Added...................................................03-26205 (d)(1) revised................................................03-34796 (d)(1) and (2) revised........................................03-49351 522.315 Added...................................................03-60296 522.480 (b)(2) amended..........................................03-59881 522.540 (a) revised.............................................03-56765 (b)(2)(i) and (c)(2) amended..................................03-59881 (a)(2)(i) amended.............................................03-65169 522.841 Added...................................................03-49704 522.900 Revised.................................................03-42969 (b)(1) amended................................................03-55824 522.1010 (b)(2) amended.........................................03-59881 522.1260 (a) and (b) revised....................................03-51705 522.1660 Heading revised........................................03-54805 (b) and (d)(1)(iii) amended...................................03-54806 522.1660a Added.................................................03-54805 522.1662a (k)(2) amended........................................03-36913 522.1680 (a) and (c)(3) revised; (b), (c)(1)(i) table and (ii) table amended; (c) footnote removed.....................................................03-36913 522.1696a (b)(1) and (3) amended................................03-34534 522.1696b (b)(2), (d)(2)(i)(A) and (iii)(A) amended.....................................................03-34534 Regulation at 68 FR 34534 corrected...........................03-42589 522.1720 (b)(1) and (2) amended; (b)(4) revised.................03-59881 522.1883 Revised................................................03-59881 522.1962 Heading and (b) amended; (a) and (c)(2) revised; (c)(3), (4) and footnote 1 removed; (c)(1) heading added........................................03-59881 522.2063 (b) amended............................................03-59881 522.2112 (b) and (c)(1) amended; (c)(2) and (3) revised.....................................................03-62006 522.2477 (b)(1), (2) and (d)(2)(i)(A) amended; (d)(2)(i)(B) and (C) redesignated as (d)(2)(i)(C) and (D); new (d)(2)(i)(B) added 03-42250 (b)(1) amended......................................03-48785, 03-55201 (b)(1) amended; (d)(1)(i)(D) revised..........................03-55200 522.2662 Revised................................................03-26206 522.2690 Added..................................................03-26995 524 Technical correction........................................03-42250 524.463 (b) amended.............................................03-55825 524.1044g (b) and (c) revised...................................03-42970 524.1376 (b) amended............................................03-33381 Regulation at 65 FR 33381 confirmed..........................03-42250 524.1580b (b) amended...........................................03-36913 524.1600a (b) amended...........................................03-55201 526.88 (b) amended..............................................03-44878 526.464b (d) amended............................................03-44878 526.464c (b) amended............................................03-44878 529.1044a (b) amended...........................................03-59881 529.1940 (d)(1), (2), (e)(1) and (2) revised; (e)(3) amended..............................................03-57613 556.36 Added....................................................03-62007 556.113 (a) redesignated as (a)(1); (a) heading and (2) added; (b)(2) amended...............................03-60296 556.346 Added...................................................03-42590 556.570 Revised.................................................03-54659 558.95 (d)(4)(ii)(b), (iii)(d), (iv)(a) and (c) amended.....................................................03-27727 558.140 (a) amended.............................................03-22294 558.145 (a)(2) amended..........................................03-47237 558.175 Revised.................................................03-17882 558.258 (e)(4) redesignated as (e)(5); new (e)(4) added.......................................................03-34534 558.305 (c) and (d) redesignated as (d) and (e); new (c) added...............................................03-42590 558.311 (b)(4) amended; (e)(2)(i) Footnote 1 and (3)(i) Footnote 1 revised; (e)(4) redesignated as (e)(5); new (e)(4) added.................................03-36745 (e)(4)(i) table amended.......................................03-51170 558.355 (f)(1)(xiv)(b) amended..................................03-55826 558.500 (d)(3) and (e)(2) added.................................03-54659 558.550 (a)(3) added; (d)(1)(xv)(c) amended.....................03-41067 (a)(3) and (d)(1)(xvi)(c) amended.............................03-54807 573.220 (c)(1)(iii) removed.....................................03-27904 573.460 (a) revised.............................................03-65633 [[Page 76]] 573.920 (h) revised.............................................03-52340 601 Nomenclature change.........................................03-24879 601.43 (a) introductory text and (b) amended....................03-34797 720.8 (a) amended...............................................03-25288 808 Nomenclature change.........................................03-24879 812 Nomenclature change.........................................03-24879 814 Nomenclature change.........................................03-24879 862.3080 Added..................................................03-40127 866.3610 Added..................................................03-62008 866.3940 Added..................................................03-61745 870.1 (e) added.................................................03-61344 870.1025 Revised................................................03-61344 870.5310 Added..................................................03-61344 872.1 (e) added.................................................03-19737 872.3660 (b) revised............................................03-19738 872.3661 Added..................................................03-19738 878.4493 (b) revised............................................03-32984 878.4495 (b) revised............................................03-32984 878.4830 (b) revised............................................03-32984 878.5000 (b) revised............................................03-32984 878.5010 (b) revised............................................03-32984 878.5020 (b) revised............................................03-32985 878.5030 (b) revised............................................03-32985 878.5035 (b) revised............................................03-32985 884.1 (e) added.................................................03-44415 884.2990 Added..................................................03-44415 886.1500 (b) correctly added; CFR correction....................03-49351 888.3045 Added..................................................03-32636 1030 Nomenclature change........................................03-24879 1240 Nomenclature change........................................03-24879 1240.63 Added; interim..........................................03-62368 1250 Nomenclature change........................................03-24879 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1300.01 (b)(43) added...........................................03-37409 (b)(41), (42) and (43) redesignated as (b)(42), (43) and (44); new (b)(41) added; interim...................03-41228 1300.02 (b)(28)(i)(E) revised...................................03-23203 (b)(28)(i)(D)(2) revised; (b)(33) and (34) added 03-57803 1301.13 (e)(1)(iii) revised.....................................03-37409 (c) revised; (e)(1)(iii) through (ix) redesignated as (e)(1)(iv) through (x); new (e)(1)(iii) added; interim..................................03-41228 (e)(1) revised................................................03-58598 1301.71 (b)(13) and (14) revised; (b)(15) added; interim.....................................................03-41228 1301.72 (b)(7) revised; interim.................................03-41228 1301.76 (d) added...............................................03-37409 1304.05 Added...................................................03-37410 1304.11 (e)(2) and (3) introductory text revised; interim.....................................................03-41228 1304.22 (b) revised; (e) added; interim.........................03-41229 1304.33 (c) revised; interim....................................03-41229 1305.03 Revised.................................................03-37410 1305.08 (b) revised; interim....................................03-41229 1306.05 (a) revised.............................................03-37410 1306.06 Revised.................................................03-37410 1306.11 (d)(5) added............................................03-37410 1306.14 (b) and (c) redesignated as (c) and (d); new (b) added...............................................03-37410 1306.15 Added...................................................03-37410 1306.24 (b) and (c) redesignated as (c) and (d); new (b) added...............................................03-37411 1306.26 (g) added...............................................03-37411 1306.27 Added...................................................03-37411 1307.11 Revised; interim........................................03-41229 1307.12 Heading and (a) revised; interim........................03-41229 1308 Regulation at 68 FR 1964 suspended.........................03-35293 Policy statement..............................................03-53289 Suspension withdrawn..........................................03-53677 1308.11 (g)(6) and (7) added....................................03-16430 1309.24 (g) revised.............................................03-37414 (e) revised...................................................03-57803 1310 Authority citation amended.................................03-62737 1310.03 (c) revised.............................................03-57804 1310.04 (h) added...............................................03-23203 (g)(1)(v) added...............................................03-53292 (c)(1) and (2), (d)(2), (e)(1) and (2), (f)(1)(ii) and (2) revised..................................03-57804 1310.05 (f) and (g) added.......................................03-57804 1310.08 (j) revised.............................................03-37414 (k) added.....................................................03-53292 1310.09 (e) added...............................................03-23203 1310.12 Added...................................................03-23204 1310.13 Added...................................................03-13204 1310.21 Added...................................................03-62737 Chapter III_Office of National Drug Control Policy (Parts 1400_1499) 1404 Revised..........................................03-66544, 03-66580 1404.440 Added..................................................03-66581 1405 Added............................................03-66557, 03-66581 1405.510 (c) amended............................................03-66582 1405.605 (a)(2) amended.........................................03-66582 Proposed Rules: 1--1299 (Ch. I).................................................03-19767 [[Page 77]] 1.......................03-16998, 03-23630, 03-25188, 03-25242, 03-56600 10..............................................................03-16461 11..............................................................03-25188 16..............................................................03-25242 101...............................03-23930, 03-41507, 03-51738, 03-66040 106...................................................03-22341, 03-38247 107...................................................03-22341, 03-38247 111.........................................03-17896, 03-19471, 03-27008 112...................................................03-19471, 03-27008 131...................................................03-39873, 03-61639 201.............................................................03-33429 310.........................................03-36527, 03-46133, 03-60302 312.............................................................03-36527 314...................................................03-36527, 03-61640 315.............................................................03-27008 320...................................................03-36527, 03-61640 333.............................................................03-32003 334...................................................03-46133, 03-60302 335.............................................................03-18915 343.............................................................03-33429 347.............................................................03-35346 348.............................................................03-42324 356.........................................03-32232, 03-50991, 03-57642 510...................................................03-31645, 03-47272 558...................................................03-31645, 03-47272 600...................................................03-36527, 03-44678 601...................................................03-27008, 03-36527 606.........................................03-36527, 03-44678, 03-61172 610.............................................................03-44678 640.............................................................03-44678 868.............................................................03-65014 870.............................................................03-65014 882.............................................................03-65014 1300............................................................03-62255 1301..............................03-37429, 03-40576, 03-53529, 03-62255 1304..................................................03-62255, 03-66048 1305............................................................03-38558 1306..................................................03-37429, 03-66048 1307............................................................03-62255 1308..................................................03-26247, 03-52872 1309............................................................03-66052 1310........................................03-24689, 03-66048, 03-66052 1311............................................................03-38558