[List of CFR Sections Affected (LSA), July 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) 3 Nomenclature change...........................................02-24879 3.1 Amended.....................................................02-37077 3.2 (b) revised.................................................02-37077 3.6 Revised.....................................................02-37077 3.7 (d) amended.................................................02-37077 3.9 (b) amended.................................................02-37077 7 Nomenclature change...........................................02-24879 10 Nomenclature change..........................................02-24879 10.20 (c)(6) and (j)(2)(ii) amended.............................02-25285 12 Nomenclature change..........................................02-24879 14.61 (d) amended...............................................02-25285 17 Nomenclature change..........................................02-24879 20.20 (e) added.................................................02-25285 20.22 Existing text designated as (a); (b) added 02-25285 [[Page 49]] 20.26 (a)(4) added; (b) revised.................................02-25285 20.27 Amended...................................................02-25285 20.28 Amended...................................................02-25285 20.29 Amended...................................................02-25285 20.33 Added.....................................................02-25285 20.34 Added.....................................................02-25285 20.40 (a) revised...............................................02-25285 20.41 (b) introductory text and (3) revised; (b)(2) amended; (c) added...................................02-25285 20.42 Redesignated as 20.45; new 20.42 added....................02-25286 20.43 Redesignated as 20.46; new 20.43 added....................02-25286 20.44 Revised...................................................02-25286 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.................................................02-25286 20.46 Redesignated as 20.48; new 20.46 redesignated from 20.43.....................................02-25286 (a) introductory text revised.................................02-25287 20.47 Redesignated as 20.49; new 20.47 redesignated from 20.45.....................................02-25286 20.48 Redesignated as 20.50; new 20.48 redesignated from 20.46.....................................02-25286 Amended.......................................................02-25287 20.49 Redesignated as 20.51; new 20.49 redesignated from 20.47.....................................02-25286 (a) and (c) revised...........................................02-25287 20.50 Redesignated as 20.52; new 20.50 redesignated from 20.48.....................................02-25286 20.51 Redesignated as 20.53; new 20.51 redesignated from 20.49.....................................02-25286 20.52 Redesignated as 20.54; new 20.52 redesignated from 20.50.....................................02-25286 20.53 Redesignated as 20.55; new 20.53 redesignated from 20.51.....................................02-25286 Amended.......................................................02-25287 20.54 Redesignated from 20.52...................................02-25286 20.55 Redesignated from 20.53...................................02-25286 20.81 (b) removed; (c) redesignated as new (b)..................02-25287 20.83 (a) amended...............................................02-25287 20.107 (a) revised..............................................02-25287 20.111 (b) and (c)(4) amended...................................02-25287 20.120 Added....................................................02-25287 25 Nomenclature change..........................................02-24879 60 Nomenclature change..........................................02-24879 100 Nomenclature change.........................................02-24879 101 Nomenclature change.........................................02-24879 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........................................02-41502 101.36 (b)(2)(i) revised; eff. 1-1-06...........................02-41505 101.80 Regulation at 67 FR 71461 confirmed......................02-39833 101.81 Regulation at 67 FR 61782 confirmed......................02-44209 101 Appendix B amended; eff. 1-1-06.............................02-41506 109 Nomenclature change.........................................02-24879 165.110 Regulation at 68 FR 9881 confirmed.......................02-9881 172.615 (a) table corrected; CFR correction.....................02-17277 184 Nomenclature change.........................................02-24879 201 Nomenclature change.........................................02-24879 201.314 (h)(1) and (4) revised..................................02-18869 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............................02-32981 310.538 (a) amended; (e) added..................................02-24348 310.545 (a)(3)(i) heading, (ii) and (d)(17) added; (d)(1) revised; eff. 4-19-04................................02-18881 (a)(18)(i), (v), (vi), and (d)(1) revised; (d)(32) added...............................................02-33376 (a)(4) redesignated as (a)(4)(i); new (a)(4)(i) heading, (ii) and (d)(34) added; (d)(1) revised.....................................................02-34291 310.548 (d)(1) corrected........................................02-37963 312 Nomenclature change.........................................02-24879 314 Nomenclature change.........................................02-24879 314.52 (a)(3) redesignated as (a)(4); new (a)(3) added.......................................................02-36703 314.53 (b), (c)(1), (2) and (3) revised.........................02-36703 314.65 Amended..................................................02-25287 314.72 (a)(2)(iii) amended......................................02-25287 [[Page 50]] 314.95 (a)(3) redesignated as (a)(4); new (a)(3) added.......................................................02-36705 328 Nomenclature change.........................................02-24879 330 Nomenclature change.........................................02-24879 335 Added; eff. 4-19-04.........................................02-18881 341.40 Corrected; eff. 12-23-04.................................02-17881 341.70 (b) corrected; eff. 12-23-04.............................02-17881 347.1--347.50 (Subpart A) Heading revised.......................02-33376 347.3 Revised...................................................02-33376 347.10 Redesignated as 347.12; new 347.10 added.................02-33377 347.12 Redesignated from 347.10.................................02-33377 347.20 Added; (d) suspended.....................................02-33377 347.10--347.20 (Subpart B) Designation and heading added.......................................................02-33377 347.50 Redesignated as 347.52; new 347.50 added.................02-33377 347.52 Redesignated from 347.50.................................02-33377 347.52 (c)(4) and (e) added; (d)(1)(i), (ii), (3) revised.....................................................02-35293 347.60 Added....................................................02-33377 347.50--347.60 (Subpart C) Designation and heading added.......................................................02-33377 349.12 (a)(3) amended...........................................02-32982 350 Added.......................................................02-34291 352 Regulation at 66 FR 67485 suspension lifted.................02-33380 352 Suspended...................................................02-33381 352.20 (b) added................................................02-33380 352.52 (c)(2) heading, (d)(4) heading, (f)(1)(ii) and (vi) revised............................................02-33380 352.60 (b)(2), (c) and (d) revised..............................02-33380 355 Nomenclature change.........................................02-24879 358.301--358.350 (Subpart D) Added..............................02-24348 369.20 Amended; eff. 4-19-04....................................02-18882 Amended.......................................................02-34293 500 Nomenclature change.........................................02-24879 509 Nomenclature change.........................................02-24879 510 Technical correction........................................02-42250 510.600 (c)(1) table and (2) table amended...........02-17882, 02-26995, 02-33381, 02-34293, 02-41066 520 Nomenclature change.........................................02-24879 520.538 (d)(1) and (2) revised..................................02-18882 520.905a (d)(4)(ii) revised; (d)(4)(iii) amended 02-26205 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.......................................02-43294 520.1198 Added..................................................02-38601 520.1350 Added..................................................02-42968 520.1660d (a)(9) added..........................................02-42968 520.1696b (b) amended...........................................02-26204 520.1720a (b)(5) added..........................................02-41066 520.1720c (a) and (b) revised; (c) removed; (d) redesignated as new (c).....................................02-43926 520.1872 (a)(3) added; (c)(1)(i) table amended..................02-22293 520.2044 (a)(3) and (b)(3) added................................02-34533 520.2340 Added..................................................02-34795 522 Nomenclature change.........................................02-24879 522.23 (b) introductory text amended............................02-33856 522.1696b Regulation at 68 FR 34534 corrected...................02-42589 522.246 (b)(1) amended..........................................02-22594 522.312 Added...................................................02-26205 (d)(1) revised................................................02-34796 522.900 Revised.................................................02-42969 522.1662a (k)(2) amended........................................02-36913 522.1680 (a) and (c)(3) revised; (b), (c)(1)(i) table and (ii) table amended; (c) footnote removed.....................................................02-36913 522.1696a (b)(1) and (3) amended................................02-34534 522.1696b (b)(2), (d)(2)(i)(A) and (iii)(A) amended.....................................................02-34534 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 02-42250 522.2662 Revised................................................02-26206 522.2690 Added..................................................02-26995 524 Technical correction........................................02-42250 524.1044g (b) and (c) revised...................................02-42970 524.1376 (b) amended............................................02-33381 Regulation at 65 FR 33381 confirmed..........................02-42250 524.1580b (b) amended...........................................02-36913 526.88 (b) amended..............................................02-44878 526.464b (d) amended............................................02-44878 526.464c (b) amended............................................02-44878 556.346 Added...................................................02-42590 [[Page 51]] 558.95 (d)(4)(ii)(b), (iii)(d), (iv)(a) and (c) amended.....................................................02-27727 558.140 (a) amended.............................................02-22294 558.175 Revised.................................................02-17882 558.258 (e)(4) redesignated as (e)(5); new (e)(4) added.......................................................02-34534 558.305 (c) and (d) redesignated as (d) and (e); new (c) added...............................................02-42590 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.................................02-36745 558.550 (a)(3) added; (d)(1)(xv)(c) amended.....................02-41067 573.220 (c)(1)(iii) removed.....................................02-27904 601 Nomenclature change.........................................02-24879 601.43 (a) introductory text and (b) amended....................02-34797 720.8 (a) amended...............................................02-25288 808 Nomenclature change.........................................02-24879 812 Nomenclature change.........................................02-24879 814 Nomenclature change.........................................02-24879 862.3080 Added..................................................02-40127 872.1 (e) added.................................................02-19737 872.3660 (b) revised............................................02-19738 872.3661 Added..................................................02-19738 878.4493 (b) revised............................................02-32984 878.4495 (b) revised............................................02-32984 878.4830 (b) revised............................................02-32984 878.5000 (b) revised............................................02-32984 878.5010 (b) revised............................................02-32984 878.5020 (b) revised............................................02-32985 878.5030 (b) revised............................................02-32985 878.5035 (b) revised............................................02-32985 884.1 (e) added.................................................02-44415 884.2990 Added..................................................02-44415 888.3045 Added..................................................02-32636 1030 Nomenclature change........................................02-24879 1240 Nomenclature change........................................02-24879 1250 Nomenclature change........................................02-24879 Chapter II--Drug Enforcement Administration, Department of Justice (Parts 1300--1399) 1300.01 (b)(43) added...........................................02-37409 (b)(41), (42) and (43) redesignated as (b)(42), (43) and (44); new (b)(41) added; interim...................02-41228 1300.02 (b)(28)(i)(E) revised...................................02-23203 1301.13 (e)(1)(iii) revised.....................................02-37409 (c) revised; (e)(1)(iii) through (ix) redesignated as (e)(1)(iv) through (x); new (e)(1)(iii) added; interim..................................02-41228 1301.71 (b)(13) and (14) revised; (b)(15) added; interim.....................................................02-41228 1301.72 (b)(7) revised; interim.................................02-41228 1301.76 (d) added...............................................02-37409 1304.05 Added...................................................02-37410 1304.11 (e)(2) and (3) introductory text revised; interim.....................................................02-41228 1304.22 (b) revised; (e) added; interim.........................02-41229 1304.33 (c) revised; interim....................................02-41229 1305.03 Revised.................................................02-37410 1305.08 (b) revised; interim....................................02-41229 1306.05 (a) revised.............................................02-37410 1306.06 Revised.................................................02-37410 1306.11 (d)(5) added............................................02-37410 1306.14 (b) and (c) redesignated as (c) and (d); new (b) added...............................................02-37410 1306.15 Added...................................................02-37410 1306.24 (b) and (c) redesignated as (c) and (d); new (b) added...............................................02-37411 1306.26 (g) added...............................................02-37411 1306.27 Added...................................................02-37411 1307.11 Revised; interim........................................02-41229 1307.12 Heading and (a) revised; interim........................02-41229 1308 Regulation at 68 FR 1964 suspended.........................02-35293 1308.11 (g)(6) and (7) added....................................02-16430 1309.24 (g) revised.............................................02-37414 1310.04 (h) added...............................................02-23203 1310.08 (j) revised.............................................02-37414 1310.09 (e) added...............................................02-23203 1310.12 Added...................................................02-23204 1310.13 Added...................................................02-13204 Proposed Rules: 1--1299 (Ch. I).................................................02-19767 1.................................02-16998, 02-23630, 02-25188, 02-25242 10..............................................................02-16461 11..............................................................02-25188 16..............................................................02-25242 101...................................................02-23930, 02-41507 106...................................................02-22341, 02-38247 107...................................................02-22341, 02-38247 111.........................................02-17896, 02-19471, 02-27008 112...................................................02-19471, 02-27008 131.............................................................02-39873 201.............................................................02-33429 310.............................................................02-36527 312.............................................................02-36527 314.............................................................02-36527 315.............................................................02-27008 320.............................................................02-36527 333.............................................................02-32003 335.............................................................02-18915 343.............................................................02-33429 [[Page 52]] 347.............................................................02-35346 348.............................................................02-42324 356.............................................................02-32232 510.............................................................02-31645 558.............................................................02-31645 600...................................................02-36527, 02-44678 601...................................................02-27008, 02-36527 606...................................................02-36527, 02-44678 610.............................................................02-44678 640.............................................................02-44678 1301..................................................02-37429, 02-40576 1305............................................................02-38558 1306............................................................02-37429 1308............................................................02-26247 1310............................................................02-24689 1311............................................................02-38558