[List of CFR Sections Affected (LSA), October 2016]
[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
Policy statement..........................................39183, 57784
Nomenclature change..............................................49895
1.1 (c) amended....................................................59131
1.20 Amended.......................................................59131
1.24 Amended.......................................................59131
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
1.900--1.934 (Subpart O) Added.....................................20166
2.125 (e)(4)(vi) and (ix) removed..................................74302
5 Nomenclature change..............................................49895
11 Policy statement.........................................54499, 57784
11.1 (n) added.....................................................20170
(o) added........................................................34218
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
20.100 (c)(22) removed.............................................45409
(c)(46) added....................................................55046
(c)(9) amended...................................................60212

[[Page 56]]

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
80 Nomenclature change.............................................49895
100 Nomenclature change............................................49895
100.155 (a) and (b) amended........................................59131
101 Policy statement..........................43061, 54499, 54501, 66527
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
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
101.105 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
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

[[Page 57]]

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
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
201.1 (f) amended..................................................60212
201.2 Amended......................................................60212
201.25 (c)(1) introductory text amended............................60212
207 Revised........................................................60212
211 Nomenclature change............................................49897
Policy statement.................................................57784
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
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;

[[Page 58]]

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
507 Nomenclature change............................................49897
Policy statement.................................................57784
507.3 Regulation at 80 FR 56337 eff. date
confirmed in part..............................................64060
510.600 (c)(1) table and (2) table amended....36788, 48702, 59133, 67151
514 Authority citation revised.....................................29141
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
515.10 (b)(8) amended..............................................60221
520 Drug application approvals withdrawn...........................36790
520.100 (b)(3) and (4) removed.....................................59133
520.110 (b) amended................................................48702
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
520.928 (c) revised................................................67151
520.1084 Added.....................................................36789
520.1430 Heading revised...........................................36789
520.1696b (b) amended..............................................36789
520.2075 (a) and (c) revised.......................................59133
520.2130 (b) amended...............................................48702
520.2134 (b) amended...............................................48702
520.2261a (b) amended..............................................36789
520.2325a (a)(2) removed; (a)(3) and (4)
redesignated as new (a)(2) and (3).............................36789
(a)(3) amended...................................................59134
520.2345c (d)(1)(iii) removed......................................67151
520.2471 (b) amended...............................................48702
520.2640 (b)(1) amended............................................48702
522.150 (b) amended................................................48702
522.224 Added......................................................67151
522.690 (b)(3) amended.............................................36789
522.840 (b) amended................................................48702
522.842 (a)(2) amended.............................................48702
522.1055 Revised...................................................59134
522.1077 (b)(3) amended............................................36789
522.1182 (b) introductory text, (7) introductory
text, (i) and (ii) amended.....................................59134
522.1192 (b)(2) amended............................................59134
522.1260 (b)(2) amended............................................59134
522.1680 (b) amended...............................................36789
522.1684 Added.....................................................36789
(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
522.2630 (d)(1)(iii)(A) revised....................................67151
522.2640 (b)(1) amended............................................48703

[[Page 59]]

Revised..........................................................67151
524.916 (b) amended................................................48703
524.998 Added......................................................67152
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
524.1484k Heading correctly revised................................25328
529.400 (a) footnote 1 removed.....................................67152
556.748 (c) revised................................................36789
558 Drug application approvals withdrawn....................36790, 59135
558.3 (b)(1)(i) and (ii) revised; (b)(13) and (14)
added..........................................................57800
558.4 (d) tables amended....................................36790, 59134
558.58 (e)(6) amended..............................................67152
558.59 Revised.....................................................67152
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
558.128 (e)(7)(xi) amended.........................................67152
558.140 (b)(2) amended.............................................63054
558.145 (a)(2) removed.............................................63054
558.195 (e)(1)(vi), (2)(iii) and (v) amended.......................67152
558.248 (a) and (b) revised; (d)(1)(iii) removed
36790
558.261 (c) and (d) redesignated as (d) and (c)....................67152
558.274 (a)(1), (c)(1)(i), (ii), (2)(i) and (ii)
amended........................................................48703
(c)(1)(ii) and (2)(ii) removed...................................59135
558.295 (b) removed................................................67152
558.325 (d)(3) revised.............................................67152
558.342 (b)(2), (e)(1)(i) through (iv), (ix) and
(x) amended....................................................48703
(e)(1)(iv), (ix), (x) and (xi) amended...........................67152
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),
(4)(ii)(b), (iii)(b) and (6)(i)(b)(2)(iii)
amended........................................................48703
(f)(1)(xxviii) removed; (f)(8)(i) and (ii)
revised........................................................59135
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
558.366 (b) and (d) amended........................................48703
(d) amended......................................................67153
558.500 (b), (e)(1)(i) through (iv), (2)(i)
through (xiii) and (3)(i) through (iv) amended
48703
558.550 (d)(1)(xxii)(B) amended....................................48703
(d)(1)(xxii) removed.............................................59135
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
558.630 (b)(1) amended.............................................48703
(b)(1) revised...................................................59135
558.633 Added......................................................36790
(d)(1) revised...................................................67153
558.665 (e)(2) through (6), (8), (10), (11) and
(12) amended...................................................48703
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
573.696 Added......................................................67154
601.2 (f) added....................................................60221
607 Heading revised................................................60221
607.1 Added........................................................60221
607.3 (b) amended; (k) and (l) added...............................60222
607.7 Revised......................................................60222
607.20 (c) amended.................................................60222

[[Page 60]]

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
801.15 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
870.4510 Added.....................................................71371
870.5200 Revised...................................................33133
870.5210 Added.....................................................33134
874.4180 Added.....................................................73029
876.5011 Added.....................................................45231
878.4420 Added.....................................................42244
878.4815 Added.....................................................64763
882.1561 Added.....................................................67155
882.5700 Added.....................................................44772
884.4050 Added.....................................................40183
886.1342 Added.....................................................65280
886.1925 Added.....................................................34270
886.5838 Added.....................................................37500
890 Authority citation revised.....................................71612
890.3450 Added.....................................................71612
890.5525 (b) revised; (c) removed..................................48706
1100 Added.........................................................29102
1105 Added.........................................................52334
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
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
1271.1 (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

Chapter II_Drug Enforcement Administration, Department of Justice (Parts
1300_1399)

1301 Policy statement..............................................53846
1301.74 (g) revised; interim.......................................58839
1301.75 (e) revised; interim.......................................58839
1305.07 Introductory text and (a) revised; interim
58839
1305.17 (d) revised; interim.......................................58839
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

[[Page 61]]

(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
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

Proposed Rules:

1....................................................28035, 43155, 75349
2...........................................................74364, 74368
11..........................................................27067, 28035
15.................................................................60299
16............................................28035, 57812, 58342, 75351
56.................................................................19066
58..........................................................58342, 75351
73..........................................................63728, 69740
101.........................................................27067, 66562
111................................................................28035
112................................................................75349
117...........................................30219, 57816, 58421, 75349
172................................................................38984
175..................................................31877, 37561, 52370
176...........................................25625, 31877, 37561, 52370
177...........................................31877, 37561, 42585, 52370
178..................................................31877, 37561, 52370
216................................................................71648
310................................................................42912
330................................................................19069
507..................................................30219, 58421, 75349
511................................................................57812
514................................................................74962
556................................................................74962
558................................................................57818
573................................................................67260
610................................................................26753
807................................................................71415
820................................................................24041
882.........................................................24386, 32258
895.........................................................24386, 32258
1005...............................................................43155
1100.................................................28778, 28780, 28781
1105...............................................................52371
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
1309...............................................................63576
1310...............................................................63576
1312...............................................................63576
1313...............................................................63576
1314...............................................................63576
1315...............................................................63576
1316...............................................................63576
1321...............................................................63576